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Regional Anesthesia Military Battlefield Pain Outcomes Study (RAMBPOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00431847
Recruitment Status : Completed
First Posted : February 6, 2007
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
Brooke Army Medical Center
University of Pennsylvania
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Anxiety Disorders
Complex Regional Pain Syndrome Type II
Depressive Disorders
Post-Traumatic Stress Disorder
Substance Abuse
Interventions Procedure: Regional Anesthesia
Procedure: Standard Pain Management Protocol
Enrollment 386
Recruitment Details Six hundred eighty-seven (687) combat-injured military service members hospitalized with at least one major limb injury were assessed for eligibility as an inpatient at one of two military treatment facilities. Three hundred one (301) of these patients did not meet criteria for study enrollment.
Pre-assignment Details Three hundred eighty-six (386) participants provided study data. Twenty-Eight (28) of these participants were excluded from group observation due to completion of less than two study visits.
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA) Unknown Treatment Status
Hide Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia. No patient data on exposure to Regional Anesthesia
Period Title: Overall Study
Started 132 45 24 184 1
Completed 126 [1] 42 [1] 20 [1] 170 [1] 0
Not Completed 6 3 4 14 1
Reason Not Completed
completion of less than two study visits             6             3             4             14             0
Protocol Violation             0             0             0             0             1
[1]
All participants with at least two study visits were included in analysis.
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA) Total
Hide Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia. Total of all reporting groups
Overall Number of Baseline Participants 126 42 20 170 358
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 42 participants 20 participants 170 participants 358 participants
28.20  (6.30) 26.68  (4.80) 29.08  (8.97) 28.15  (7.87) 28.04  (7.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 42 participants 20 participants 170 participants 358 participants
Female
0
   0.0%
1
   2.4%
0
   0.0%
2
   1.2%
3
   0.8%
Male
126
 100.0%
41
  97.6%
20
 100.0%
168
  98.8%
355
  99.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 42 participants 20 participants 170 participants 358 participants
Hispanic or Latino
14
  11.1%
8
  19.0%
4
  20.0%
19
  11.2%
45
  12.6%
Not Hispanic or Latino
112
  88.9%
34
  81.0%
16
  80.0%
151
  88.8%
313
  87.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 42 participants 20 participants 170 participants 358 participants
American Indian or Alaska Native
2
   1.6%
1
   2.4%
0
   0.0%
6
   3.5%
9
   2.5%
Asian
5
   4.0%
3
   7.1%
0
   0.0%
6
   3.5%
14
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   4.0%
0
   0.0%
2
  10.0%
12
   7.1%
19
   5.3%
White
101
  80.2%
31
  73.8%
17
  85.0%
129
  75.9%
278
  77.7%
More than one race
12
   9.5%
6
  14.3%
1
   5.0%
17
  10.0%
36
  10.1%
Unknown or Not Reported
1
   0.8%
1
   2.4%
0
   0.0%
0
   0.0%
2
   0.6%
Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 126 participants 42 participants 20 participants 170 participants 358 participants
High School/GED 47 18 8 74 147
Some College 47 18 9 72 146
Bachelor's Degree or Higher 32 6 3 24 65
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 126 participants 42 participants 20 participants 170 participants 358 participants
Never Married 51 19 7 89 166
Married or Living w/Partner 70 22 13 67 172
Separated/Divorced 5 1 0 14 20
Number of Deployments, Continuous  
Mean (Standard Deviation)
Unit of measure:  Deployments
Number Analyzed 126 participants 42 participants 20 participants 170 participants 358 participants
2.13  (1.27) 1.80  (0.90) 2.40  (2.54) 1.85  (1.05) 1.97  (1.25)
Injury Severity Score (ISS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 126 participants 42 participants 20 participants 170 participants 358 participants
17.31  (8.56) 19.74  (11.88) 24.65  (12.59) 18.07  (11.57) 18.37  (10.79)
[1]
Measure Description: Injury Severity Scores (ISS): ISS is a scale to evaluate anatomic injury severity following trauma that ranges from 0 to 75, with 75 indicating the greatest severity. An Abbreviated Injury Scale (AIS) score is allocated to the six body regions (Head, Face, Chest, Abdomen, Extremities, and External). The highest AIS score in each body region is used. The 3 most severely injured body regions scores are squared and summed to produce the ISS. The ISS correlates linearly with mortality, morbidity, and hospital stay.
Length of Initial Hospital Stay  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 126 participants 42 participants 20 participants 170 participants 358 participants
41.14  (30.54) 47.45  (33.74) 59.90  (47.64) 27.95  (30.72) 36.69  (33.35)
1.Primary Outcome
Title Neuropathic Pain Scale - Pain Intensity
Hide Description The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. Item numbers ask respondents to describe the intensity of their combat limb pain on a scale of 0 - 10, where "0" is no pain and "10" is the most intense pain imaginable.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on the Neuropathic Pain Scale
3  (0.16) 3.44  (0.3) 3.92  (0.45) 3.04  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.03230
Confidence Interval (2-Sided) 95%
-0.0448 to -0.02013
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.006190
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4492
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi Squared
Estimated Value 2.65
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.640
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1080
Confidence Interval (2-Sided) 95%
-0.5621 to 0.3461
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2308
Estimation Comments Estimated intercept group difference
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3286
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3299
Confidence Interval (2-Sided) 95%
-0.3334 to 0.9932
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3372
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0694
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.8591
Confidence Interval (2-Sided) 95%
-0.06841 to 1.7866
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.4716
Estimation Comments [Not Specified]
2.Primary Outcome
Title Neuropathic Pain Scale - Overall Pain Quality
Hide Description The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. The NPS Overall Pain Quality composite score is a measure of six distinct pain qualities of respondents' combat limb pain on a scale of 0 - 10, where "0" is no pain and "10" is the most intense sensation imaginable. The six pain qualities included in the composite score is sharp, hot, dull, cold, itchy, and sensitive to touch.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on the Neuropathic Pain Scale
1.90  (0.11) 2.04  (0.20) 2.13  (0.27) 1.82  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.02332
Confidence Interval (2-Sided) 95%
-0.03076 to -0.01589
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.003777
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4772
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 2.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6077
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.07724
Confidence Interval (2-Sided) 95%
-0.2184 to 0.3729
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1503
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3616
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2004
Confidence Interval (2-Sided) 95%
-0.2311 to 0.6319
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2194
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3155
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3082
Confidence Interval (2-Sided) 95%
-0.2948 to 0.9112
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3066
Estimation Comments [Not Specified]
3.Primary Outcome
Title Neuropathic Pain Scale - Total Score
Hide Description The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. It has a scale of 0 - 10, where "0" is no pain and "10" is the most intense sensation imaginable. The NPS total score is an average of all ten items.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on the Neuropathic Pain Scale
2.35  (0.12) 2.60  (0.22) 2.80  (0.31) 2.29  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.02746
Confidence Interval (2-Sided) 95%
-0.03573 to -0.01919
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.004202
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3345
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 3.40
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8223
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.03860
Confidence Interval (2-Sided) 95%
-0.2993 to 0.3765
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1718
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2448
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2919
Confidence Interval (2-Sided) 95%
-0.2009 to 0.7848
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2506
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2014
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4482
Confidence Interval (2-Sided) 95%
-0.2405 to 1.1369
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3502
Estimation Comments [Not Specified]
4.Primary Outcome
Title Brief Pain Inventory - Worst Pain
Hide Description The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Worst Pain asks the respondent to rate worst pain in the past week from the combat limb injury on a scale of 0 to 10, where "0" is no pain, and "10" is pain as bad as you can imagine.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on the Brief Pain Inventory Scale
4.54  (0.18) 4.95  (0.36) 5.83  (0.44) 4.62  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.04030
Confidence Interval (2-Sided) 95%
-0.5446 to -0.02613
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.007196
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3631
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 3.19
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7148
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1004
Confidence Interval (2-Sided) 95%
-0.6404 to 0.4396
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2746
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3741
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3568
Confidence Interval (2-Sided) 95%
-0.4318 to 1.1453
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.4009
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0213
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.2969
Confidence Interval (2-Sided) 95%
0.1938 to 2.4000
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.5609
Estimation Comments [Not Specified]
5.Primary Outcome
Title Brief Pain Inventory - Average Pain
Hide Description The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Average Pain asks the respondent to rate combat limb injury pain on average (no time frame given) on a scale of 0 to 10, where "0" is no pain, and "10" is pain as bad as you can imagine.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on the Brief Pain Inventory Scale
2.18  (0.13) 2.45  (0.23) 3.21  (0.42) 2.45  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.02776
Confidence Interval (2-Sided) 95%
-0.03702 to -0.01850
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.004706
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2752
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 3.88
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1094
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3079
Confidence Interval (2-Sided) 95%
-0.6851 to 0.06941
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1918
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8786
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0428
Confidence Interval (2-Sided) 95%
-0.5079 to 0.5935
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2800
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0847
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6759
Confidence Interval (2-Sided) 95%
-0.09297 to 1.4448
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3910
Estimation Comments [Not Specified]
6.Primary Outcome
Title Brief Pain Inventory - Pain Interference
Hide Description The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is scored as the mean of the seven interference items, each ranging 0 to 10, where "0" is pain from combat limb injury does not interfere and "10" is pain from combat limb injury completely interferes with this aspect of daily life.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on the Brief Pain Inventory Scale
1.91  (0.15) 2.03  (0.25) 2.57  (0.46) 1.88  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.03645
Confidence Interval (2-Sided) 95%
-0.04808 to -0.02481
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.005913
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3677
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 3.16
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7926
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.05816
Confidence Interval (2-Sided) 95%
-0.4929 to 0.3766
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2210
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5953
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1708
Confidence Interval (2-Sided) 95%
-0.4610 to 0.8026
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3212
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1261
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6873
Confidence Interval (2-Sided) 95%
-0.1943 to 1.5689
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.4482
Estimation Comments [Not Specified]
7.Primary Outcome
Title Brief Pain Inventory - Treatment Relief
Hide Description The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess the severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures in the last 24 hours, how much relief pain treatments or medications provided on a scale of 0%, meaning no relief, to 100%, indicating complete relief.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: percentage of pain relief
67.53  (2.39) 66.80  (3.04) 58.58  (4.88) 66.77  (1.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.4831
Confidence Interval (2-Sided) 95%
-0.7286 to -0.2377
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1243
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3617
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 3.20
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2532
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.1574
Confidence Interval (2-Sided) 95%
-2.2715 to 8.5863
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.7573
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7580
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.2227
Confidence Interval (2-Sided) 95%
-6.5833 to 9.0286
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.9633
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1837
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.1649
Confidence Interval (2-Sided) 95%
-17.7484 to 3.4187
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.3759
Estimation Comments [Not Specified]
8.Primary Outcome
Title SF-36 Physical Component Summary
Hide Description The Physical component score (PCS) is an aggregate of the eight subscale scores measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is calculated for each by subtracting the scale mean of a sample of the U.S. general population from an individual’s scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the PCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the PCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: t-score
40.30  (0.96) 37.00  (1.72) 31.51  (2.05) 41.94  (0.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.4741
Confidence Interval (2-Sided) 95%
0.3971 to 0.5511
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03909
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6075
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 1.83
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4558
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9534
Confidence Interval (2-Sided) 95%
-3.4675 to 1.5607
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.2763
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0914
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.3505
Confidence Interval (2-Sided) 95%
-7.2442 to 0.5432
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.9770
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.3700
Confidence Interval (2-Sided) 95%
-14.4589 to -2.2810
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.0921
Estimation Comments [Not Specified]
9.Primary Outcome
Title SF-36 Mental Component Summary
Hide Description The Mental component score (MCS) is an aggregate of the eight subscale scores that account for measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the U.S. general population from an individual’s scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the MCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the MCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: t-score
52.47  (1.11) 52.12  (1.84) 49.90  (2.94) 51.30  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.2169
Confidence Interval (2-Sided) 95%
-0.2987 to -0.1352
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04148
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0950
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 6.37
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5878
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7246
Confidence Interval (2-Sided) 95%
-1.9056 to 3.3547
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3351
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9053
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2466
Confidence Interval (2-Sided) 95%
-4.3231 to 3.8299
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.0697
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4682
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.3457
Confidence Interval (2-Sided) 95%
-8.7034 to 4.0120
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.2285
Estimation Comments [Not Specified]
10.Primary Outcome
Title Post Traumatic Stress Disorder (PTSD) Total Severity
Hide Description Post-Traumatic Stress Disorder Checklist (PCL): The PCL is a 17-item PTSD assessment instrument that asks respondents to rate the extent to which they have experienced each of the 17 diagnostic symptoms for PTSD outlined in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV). Scores are computed by adding the 17 items scored 1 to 5. Scores range from 17 to 85. Higher scores indicate higher severity of symptoms.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on the PCL scale
27.99  (1.10) 30.23  (1.98) 25.62  (2.00) 27.63  (0.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1938
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.04639
Confidence Interval (2-Sided) 95%
-0.02369 to 0.1165
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03562
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4884
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 2.43
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6593
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6174
Confidence Interval (2-Sided) 95%
-2.1348 to 3.3696
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3991
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0889
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.4575
Confidence Interval (2-Sided) 95%
-0.5280 to 7.4431
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.0263
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8727
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4499
Confidence Interval (2-Sided) 95%
-5.9692 to 5.0694
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.8061
Estimation Comments [Not Specified]
11.Primary Outcome
Title Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance
Hide Description Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on TOPS scale
41.85  (2.07) 43.57  (3.65) 51.27  (6.29) 40.62  (1.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.5230
Confidence Interval (2-Sided) 95%
-0.6973 to -0.3486
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08855
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1800
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 4.89
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4151
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.3020
Confidence Interval (2-Sided) 95%
-3.2530 to 7.8570
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.8198
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3157
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.3376
Confidence Interval (2-Sided) 95%
-4.1592 to 12.8344
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.3140
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0911
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 11.8250
Confidence Interval (2-Sided) 95%
-1.9040 to 25.5541
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.9715
Estimation Comments [Not Specified]
12.Primary Outcome
Title Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction
Hide Description Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the health care satisfaction scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on TOPS scale
61.01  (1.80) 56.29  (3.54) 47.68  (4.67) 58.77  (1.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.2888
Confidence Interval (2-Sided) 95%
-0.4675 to -0.1100
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09078
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0966
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 6.33
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2195
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.9879
Confidence Interval (2-Sided) 95%
-1.7938 to 7.7697
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4264
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5105
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.4636
Confidence Interval (2-Sided) 95%
-9.8289 to 4.9018
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.7381
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0903
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.3871
Confidence Interval (2-Sided) 95%
-22.4174 to 1.6433
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.1087
Estimation Comments [Not Specified]
13.Primary Outcome
Title Treatment Outcomes in Pain Survey (TOPS):Life Control
Hide Description Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on TOPS scale
75.82  (1.92) 68.02  (4.15) 58.52  (5.76) 73.76  (1.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6602
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.04113
Confidence Interval (2-Sided) 95%
-0.2252 to 0.1429
Parameter Dispersion
Type: Standard Error of the Mean
Value: -0.04113
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6764
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 1.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3458
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.4902
Confidence Interval (2-Sided) 95%
-2.7036 to 7.6840
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.6357
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1969
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.2518
Confidence Interval (2-Sided) 95%
-13.2466 to 2.7430
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.0583
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0480
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -12.9796
Confidence Interval (2-Sided) 95%
-25.8429 to -0.1162
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.5287
Estimation Comments [Not Specified]
14.Primary Outcome
Title Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability
Hide Description Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on TOPS scale
48.29  (2.37) 51.04  (4.05) 57.51  (4.33) 47.87  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0199
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.2349
Confidence Interval (2-Sided) 95%
-0.4323 to -0.03745
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1003
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4577
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 2.60
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7417
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9502
Confidence Interval (2-Sided) 95%
-6.6240 to 4.7236
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.8797
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7778
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.2580
Confidence Interval (2-Sided) 95%
-7.5129 to 10.0289
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.4523
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2411
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.5232
Confidence Interval (2-Sided) 95%
-5.7608 to 22.8073
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.2532
Estimation Comments [Not Specified]
15.Primary Outcome
Title Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes
Hide Description Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the satisfaction with outcomes scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on TOPS scale
66.72  (1.75) 61.46  (3.56) 53.06  (5.00) 66.24  (1.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0504
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.1629
Confidence Interval (2-Sided) 95%
-0.00029 to 0.3261
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08284
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6942
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 1.45
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5297
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.5241
Confidence Interval (2-Sided) 95%
-3.2469 to 6.2951
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4216
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3155
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.7679
Confidence Interval (2-Sided) 95%
-11.1478 to 3.6120
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.7464
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1105
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.7558
Confidence Interval (2-Sided) 95%
-21.7515 to 2.2399
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.0920
Estimation Comments [Not Specified]
16.Primary Outcome
Title Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms
Hide Description Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on TOPS scale
35.97  (1.92) 41.22  (3.86) 48.82  (5.91) 36.80  (1.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -.2979
Confidence Interval (2-Sided) 95%
-0.4465 to -0.1493
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.07538
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4361
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 2.72
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7297
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9001
Confidence Interval (2-Sided) 95%
-6.0247 to 4.2246
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.6015
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2868
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.2896
Confidence Interval (2-Sided) 95%
-3.6250 to 12.2043
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.0186
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1516
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.0118
Confidence Interval (2-Sided) 95%
-3.3270 to 21.3505
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.2663
Estimation Comments [Not Specified]
17.Primary Outcome
Title Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses
Hide Description Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Time Frame Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
Hide Arm/Group Description:
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Overall Number of Participants Analyzed 126 42 20 170
Mean (Standard Error)
Unit of Measure: units on TOPS scale
48.29  (2.37) 51.07  (5.18) 71.65  (6.85) 48.02  (2.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury. T
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.9776
Confidence Interval (2-Sided) 95%
-1.2584 to -0.6967
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1426
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8548
Comments [Not Specified]
Method Chi-squared
Comments Degrees of Freedom: 3
Method of Estimation Estimation Parameter Chi-Squared
Estimated Value 0.78
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3882
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.3635
Confidence Interval (2-Sided) 95%
-4.3026 to 11.0296
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.8899
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9322
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5029
Confidence Interval (2-Sided) 95%
-12.1376 to 11.1317
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.9044
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0233
Comments [Not Specified]
Method Mixed Models Analysis
Comments RA groups treated as classification variables with No RA group as reference.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 21.1166
Confidence Interval (2-Sided) 95%
2.8992 to 39.3341
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.2462
Estimation Comments [Not Specified]
Time Frame 0, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24 months after start of injury rehabilitation
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA)
Hide Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
All-Cause Mortality
RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/126 (0.00%)   0/42 (0.00%)   0/20 (0.00%)   0/170 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/126 (0.00%)   0/42 (0.00%)   0/20 (0.00%)   0/170 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Rollin M Gallagher, MD, MPH
Organization: Philadelphia Veterans Affairs Medical Center
Phone: (215) 823-5800 ext 4907
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00431847     History of Changes
Obsolete Identifiers: NCT01710475
Other Study ID Numbers: D4506-I
First Submitted: February 2, 2007
First Posted: February 6, 2007
Results First Submitted: February 8, 2016
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017