ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 33 for:    " July 27, 2011":" August 26, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy

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: NCT01419314
Recruitment Status : Completed
First Posted : August 18, 2011
Results First Posted : January 3, 2013
Last Update Posted : January 3, 2013
Sponsor:
Collaborators:
Harris County Hospital District
DJO Incorporated
Information provided by (Responsible Party):
Robert Sandoval, Texas Woman's University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions HIV
AIDS
Peripheral Neuropathy
Pain
Sleep
Interventions Device: Splinting application to the lower extremities
Device: Splint liner application
Enrollment 46

Recruitment Details The participants were randomized to use a night application of bilateral lower extremity splints (23 participants) or using the soft liners of the splints only (23 participants). One participant was excluded from the liner group as he failed to disclose a recent diabetes diagnosis.
Pre-assignment Details One of the participants in the liner group was excluded from the study at the beginning as he developed type-II diabetes. The total number of participants in the liner group was thus 22 at baseline.
Arm/Group Title Splinting Application Splint Liner Application
Hide Arm/Group Description Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only. The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
Period Title: Start of Study
Started 23 [1] 22 [2]
Completed 23 22
Not Completed 0 0
[1]
minor comfort issues were reported within the first 2 weeks of the trial
[2]
No comfort issues reported.
Period Title: Follow-up at Week 3 of the Trial
Started 23 [1] 22 [2]
Completed 17 21
Not Completed 6 1
Reason Not Completed
Withdrawal by Subject             3             1
Lost to Follow-up             3             0
[1]
3 participants discontinued the trial, 3 failed to return for additional follow-ups.
[2]
one participant failed to return for the 3 week follow-up
Period Title: Follow-up at Week 6 of the Trial
Started 17 21 [1]
Completed 16 [2] 19
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             2
[1]
2 participants did not return for their final follow-up
[2]
2 people who missed the first follow-up, returned for the final follow-up at week 6 (n=18).
Arm/Group Title LE Splints Group Splint Liner Application Total
Hide Arm/Group Description Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only. The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance. Total of all reporting groups
Overall Number of Baseline Participants 23 22 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
22
 100.0%
45
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 22 participants 45 participants
50.65  (8.04) 46.09  (7.71) 48.42  (8.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
Female
9
  39.1%
10
  45.5%
19
  42.2%
Male
14
  60.9%
12
  54.5%
26
  57.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
American Indian or Alaska Native 0 0 0
Asian 0 1 1
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 12 12 24
White 9 6 15
Latino 2 3 5
Unknown or Not Reported 0 0 0
CD4   [1] 
Mean (Standard Deviation)
Unit of measure:  Cells/mm3
Number Analyzed 23 participants 22 participants 45 participants
586.13  (233.64) 446.09  (232.54) 517.67  (241.07)
[1]
Measure Description: The most recent CD4 cell counts were extracted from the medical record.
Log Viral load   [1] 
Log Mean (Standard Deviation)
Unit of measure:  Log (copies/ml)
Number Analyzed 23 participants 22 participants 45 participants
2.25  (1.08) 1.96  (0.75) 2.10  (0.93)
[1]
Measure Description: The most recent measured HIV viral load (log viral load) was extracted from the medical record. Measured in viral copies/ml on a logarithmic scale with 1.48 log/ml representing undetectable viral load levels for the viral load test conducted in our site (less than 50 copies/ml)
Years living with HIV   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 22 participants 45 participants
11.30  (6.01) 10.32  (7.62) 10.82  (6.79)
[1]
Measure Description: The number of years living with HIV was calculated by subtracting the year of diagnosis to the year of sutdy enrollment.
Pain scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a 0-100 scale.
Number Analyzed 23 participants 22 participants 45 participants
61.35  (20.98) 60.16  (14.35) 60.77  (17.85)
[1]
Measure Description: Neuropathic Pain Scale (NPS) score, where a score of "0" equates to "no pain" and "100" is the maximum neuropathic pain score possible. The scale score is computed by totaling all 10 pain sub-scales, each individually scored from 0-10.
Sleep Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a 0-21 scale
Number Analyzed 23 participants 22 participants 45 participants
14.13  (3.89) 15.14  (4.68) 14.62  (4.28)
[1]
Measure Description: Pittsburgh Sleep Quality Index (PSQI),this is a 0-21 score scale with 21/21 denoting maximum sleep disturbances. The PSQI is scored by adding all seven sub-scales, each with a maximum score of three. A score greater than 5/21 characterizes the individual as a "poor sleeper."
Function- Forward reach   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 23 participants 22 participants 45 participants
35.31  (6.45) 36.88  (8.36) 36.07  (7.37)
[1]
Measure Description: The average of 3 reaching trials are reported. One participant in the liner group had extreme reaching values (>3 standard deviation from the mean) and was excluded from the report (n=22). Longer distances in this test represent better volitional control of balance in the sagittal plane. Reaching distances >30 cm are considered to be within normal limits.
Function-Walking Distance   [1] 
Mean (Standard Deviation)
Unit of measure:  Meters (m)
Number Analyzed 23 participants 22 participants 45 participants
246.00  (133.71) 241.89  (151.46) 243.99  (141.04)
[1]
Measure Description: The 6 minute walk distance was collected on all participants. Longer walking distances represent decreased impact on function. Non-HIV cohorts typically are able to walk 400-600m in six-minutes.
1.Primary Outcome
Title Pain Scores at Week 3
Hide Description A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.
Time Frame Week 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The total number of participants returning for the first follow-up at week three with complete data.
Arm/Group Title Lower Extremity Splinting Application Splint Liner
Hide Arm/Group Description:
nighttime splint application to the lower extremities
Night time application of lower extremity splint liner
Overall Number of Participants Analyzed 16 21
Mean (Standard Deviation)
Unit of Measure: units on a scale 0-100 (0= no pain)
50.53  (16.48) 53.76  (15.41)
2.Primary Outcome
Title Pain Scores
Hide Description A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.
Time Frame Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The total number of participants that completed the 6 week trial in each investigational group
Arm/Group Title Splinting Application Splint Liner Application
Hide Arm/Group Description:
Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: units on a scale 0-100 (0=no pain)
40.22  (18.57) 49.89  (21.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Splinting Application, Splint Liner Application
Comments A repeated measure ANOVA was performed to evaluate the contrasts of interest.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments Sphericity was not tenable for the factor pain scores, degrees of freedom were corrected using Huynh-Feldt estimates, df (1.71,56.46).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 45.19
Confidence Interval (2-Sided) 95%
38.33 to 52.05
Parameter Dispersion
Type: Standard Deviation
Value: 20.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Splinting Application
Comments Null hypothesis: Is there a difference in baseline pain scores compared to those at week 6 in the splinting group?
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0005
Comments Bonferroni adjustment for significance<0.013.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.09
Confidence Interval (2-Sided) 95%
8.80 to 23.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.60
Estimation Comments Paired t-test contrasting pain scores from baseline to week six of the trial-Splint group. The statistical power for the within splint intervention contrast was calculated to be 0.99.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Splinting Application, Splint Liner Application
Comments Null Hypothesis: There is not difference in pain scores between the liner and splint applications at week three.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.155
Comments Bonferroni adjustment for significance<0.013.
Method t-test, 2 sided
Comments df(35)
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.23
Confidence Interval (2-Sided) 95%
-13.93 to 7.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.27
Estimation Comments The statistical power for the between intervention contrast was calculated to be 0.26
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Splinting Application, Splint Liner Application
Comments Null Hypothesis: There is no difference in pain scores between the liner and splint applications at week six.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.155
Comments [Not Specified]
Method t-test, 2 sided
Comments df(35)
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.67
Confidence Interval (2-Sided) 95%
-23.20 to 3.85
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.66
Estimation Comments [Not Specified]
3.Primary Outcome
Title Sleep Quality/Quantity Scores (PSQI)
Hide Description The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions.
Time Frame week 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants returning for the first follow-up with complete data.
Arm/Group Title Splinting Application Splint Liner Application
Hide Arm/Group Description:
Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
Overall Number of Participants Analyzed 16 21
Mean (Standard Deviation)
Unit of Measure: Scores ranging 0-21, 0=no disturbances
13.13  (4.51) 14.29  (4.58)
4.Primary Outcome
Title Sleep Quality/Quantity Scores (PSQI)
Hide Description The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.
Time Frame week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants returning for the second follow-up
Arm/Group Title Splinting Application Splint Liner Application
Hide Arm/Group Description:
Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: Scores ranging 0-21, 0=no disturbances
12.06  (4.84) 11.95  (5.57)
5.Secondary Outcome
Title Function-Reach
Hide Description

Forward reach test

For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed "to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor". The average distance of three reaching attempts was recorded and used in the analysis.

Time Frame week 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.
Arm/Group Title Lower Extremity Splinting Application Splint Liner
Hide Arm/Group Description:
nighttime splint application to the lower extremities
Night time application of lower extremity splint liner
Overall Number of Participants Analyzed 16 20
Mean (Standard Deviation)
Unit of Measure: Centimeters (cm)
38.76  (6.76) 38.35  (7.04)
6.Secondary Outcome
Title Function-Reach
Hide Description

Forward reach test

For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed "to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor". The average distance of three reaching attempts was recorded and used in the analysis.

Time Frame week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.
Arm/Group Title Lower Extremity Splinting Application Splint Liner
Hide Arm/Group Description:
nighttime splint application to the lower extremities
Night time application of lower extremity splint liner
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: Centimeters (cm)
40.00  (6.22) 39.34  (6.22)
7.Secondary Outcome
Title Function-Walking Distance
Hide Description

Six minute walk test

For this test the participants were instructed to: "Please walk as far, as fast and as safe as you can for up to six minutes". The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor.

Time Frame week 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants returning for the 3 week follow-up with complete data
Arm/Group Title Lower Extremity Splinting Application Splint Liner
Hide Arm/Group Description:
nighttime splint application to the lower extremities
Night time application of lower extremity splint liner
Overall Number of Participants Analyzed 16 19
Mean (Standard Deviation)
Unit of Measure: Meters (m)
255.84  (143.58) 263.52  (156.74)
8.Secondary Outcome
Title Function-Walking Distance
Hide Description

Six minute walk test

For this test the participants were instructed to: "Please walk as far, as fast and as safe as you can for up to six minutes". The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor.

Time Frame week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants returning for the 6 week follow-up
Arm/Group Title Lower Extremity Splinting Application Splint Liner
Hide Arm/Group Description:
nighttime splint application to the lower extremities
Night time application of lower extremity splint liner
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: Meters (m)
279.52  (146.61) 304.90  (137.63)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lower Extremity Splinting Application Splint Liner
Hide Arm/Group Description nighttime splint application to the lower extremities Night time application of lower extremity splint liner
All-Cause Mortality
Lower Extremity Splinting Application Splint Liner
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lower Extremity Splinting Application Splint Liner
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lower Extremity Splinting Application Splint Liner
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
The contrast between the splinting group and liner group was statistically underpowered. The data was collected and analyzed by the primary investigator. The clinical diagnosis of peripheral neuropathy was not confirmed with EMG or punch skin biopsy.
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: Roberto Sandoval PT
Organization: Texas Woman's University
Phone: 713-859-9351
Responsible Party: Robert Sandoval, Texas Woman's University
ClinicalTrials.gov Identifier: NCT01419314     History of Changes
Other Study ID Numbers: 16196
First Submitted: August 10, 2011
First Posted: August 18, 2011
Results First Submitted: September 13, 2012
Results First Posted: January 3, 2013
Last Update Posted: January 3, 2013