Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

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: NCT00597766
Recruitment Status : Completed
First Posted : January 18, 2008
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Information provided by (Responsible Party):
John Chae, MD, MetroHealth Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Shoulder Pain
Interventions Drug: Lidocaine
Drug: Triamcinolone + Lidocaine
Enrollment 28
Recruitment Details Subjects were recruited from an urban, academic rehabilitation center from 10/2007 to 6/2012 in the United States.
Pre-assignment Details Subjects had to have a positive Neer's test (50% pain reduction by subacromial lidocaine) to be enrolled and randomized. 59 were screened. 28 subjects were consented and enrolled.
Arm/Group Title 20mg Triamcinolone 40mg Triamcinolone 60mg Triamcinolone
Hide Arm/Group Description Low dose group. Standard dose group High dose group
Period Title: Enrolled
Started 9 9 10
Completed 9 9 10
Not Completed 0 0 0
Period Title: Follow-up 1, Week 4
Started 9 9 10
Completed 8 9 10
Not Completed 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Period Title: Follow-up 2, Week 8
Started 8 9 10
Completed 8 9 9
Not Completed 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             1
Period Title: Follow-up 3, Week 12
Started 8 9 9
Completed 8 9 9
Not Completed 0 0 0
Arm/Group Title 20mg Triamcinolone 40mg Triamcinolone 60mg Triamcinolone Total
Hide Arm/Group Description Low dose group. Standard dose group High dose group Total of all reporting groups
Overall Number of Baseline Participants 9 9 10 28
Hide Baseline Analysis Population Description
The number of participants was determined on a power analysis. The goal was 31 subjects per group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 10 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  77.8%
8
  88.9%
9
  90.0%
24
  85.7%
>=65 years
2
  22.2%
1
  11.1%
1
  10.0%
4
  14.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 10 participants 28 participants
58.3  (7.1) 54.7  (10.2) 54.0  (9.9) 55.6  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 10 participants 28 participants
Female
4
  44.4%
3
  33.3%
5
  50.0%
12
  42.9%
Male
5
  55.6%
6
  66.7%
5
  50.0%
16
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 10 participants 28 participants
9 9 10 28
1.Primary Outcome
Title BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire
Hide Description Change in BPI-12, Worst pain in the last week on 0 (No Pain) to 10 (Worst Pain Possible) scale, from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
Time Frame Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)
Hide Outcome Measure Data
Hide Analysis Population Description
We used available-cases. Missing values handled with maximum likelihood methods.
Arm/Group Title 20mg Triamcinolone 40mg Triamcinolone 60mg Triamcinolone
Hide Arm/Group Description:
Low dose group.
Standard dose group
High dose group
Overall Number of Participants Analyzed 9 9 10
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.7
(-3.9 to 0.6)
-2.2
(-4.4 to 0.0)
-4.7
(-6.8 to -2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20mg Triamcinolone, 60mg Triamcinolone
Comments

Hypothesis that 60mg group would have greater pain relief than the the 20mg group.

The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size > 1.0),18 participants per group are needed. *NOTE* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments Comparison 60mg vs. 20mg: F (1,92)=2.06, p=0.16
Method Linear mixed model
Comments 1st order antedependence covariance structure
Method of Estimation Estimation Parameter GroupXtime interaction
Estimated Value -0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20mg Triamcinolone, 40mg Triamcinolone
Comments

Hypothesis that 40mg group would have greater pain reduction than the 20mg group.

The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size > 1.0),18 participants per group are needed. *NOTE* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments Comparison 40mg vs. 20mg: F (1,90)=0.1, p=0.77
Method linear mixed model
Comments first order antedependent covariance structure
Method of Estimation Estimation Parameter group x time interaction
Estimated Value -0.04
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Fugl-Meyer Motor Assessment, Upper Limb Domain
Hide Description

Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale:

0 = cannot perform

  1. = performs partially
  2. = performs fully Scores for 33 motor function items are summed to arrive at a total score ranging from 0 to 66, where higher scores indicate greater motor function Differences baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
Time Frame Baseline, weeks 4, 8, 12 (4 times)
Hide Outcome Measure Data
Hide Analysis Population Description
Available-case analysis with missing data handled by maximum likelihood methods.
Arm/Group Title 20mg Triamcinolone 40mg Triamcinolone 60mg Triamcinolone
Hide Arm/Group Description:
Low dose group.
Standard dose group
High dose group
Overall Number of Participants Analyzed 9 9 10
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
5.1
(-0.1 to 10.4)
4.5
(-0.9 to 9.8)
2.3
(-2.8 to 7.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20mg Triamcinolone, 60mg Triamcinolone
Comments This study was not powered for secondary outcomes. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments Comparison 60mg vs. 20mg: F (1,36)=1.7, p=0.2
Method Linear mixed model
Comments first order antedpendent covariance structure
Method of Estimation Estimation Parameter group x time interaction
Estimated Value -0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20mg Triamcinolone, 40mg Triamcinolone
Comments This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments Comparison 40mg vs. 20mg: F (1,35)=0.0, p=0.9
Method linear mixed model
Comments 1st order antedependence covariance structure
Method of Estimation Estimation Parameter group x time interaction
Estimated Value -0.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Pain Free External Rotation Range of Motion (ROM)
Hide Description Differences in least-mean squares (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
Time Frame Baseline, weeks 4, 8, 12 (4 times)
Hide Outcome Measure Data
Hide Analysis Population Description
Available-case analysis with missing data handled by maximum likelihood methods.
Arm/Group Title 20mg Triamcinolone 40mg Triamcinolone 60mg Triamcinolone
Hide Arm/Group Description:
Low dose group.
Standard dose group
High dose group
Overall Number of Participants Analyzed 9 9 10
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
26.7
(8.2 to 45.1)
12.7
(-6.0 to 31.4)
10.3
(-7.5 to 28.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20mg Triamcinolone, 60mg Triamcinolone
Comments The study was not powered for secondary analyses. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments Comparison 60mg vs. 20mg: F (1,36)=1.6, p=0.2
Method linear mixed model
Comments unstructured covariance structure
Method of Estimation Estimation Parameter Groupxtime interaction
Estimated Value 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20mg Triamcinolone, 40mg Triamcinolone
Comments Secondary outcomes were not powered for analysis. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments Comparison 40mg vs. 20mg: F (1,35)=1.0, p=0.3
Method linear mixed model
Comments Unstructured covariance structure
Method of Estimation Estimation Parameter Groupxtime interaction
Estimated Value 1.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Pain Free Abduction Range of Motion (ROM)
Hide Description Difference in least-squares means (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
Time Frame Baseline, weeks 4, 8, 12 (4 times)
Hide Outcome Measure Data
Hide Analysis Population Description
Available-case analysis with missing data handled by maximum likelihood methods.
Arm/Group Title 20mg Triamcinolone 40mg Triamcinolone 60mg Triamcinolone
Hide Arm/Group Description:
Low dose group.
Standard dose group
High dose group
Overall Number of Participants Analyzed 9 9 10
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
33.3
(7.9 to 58.7)
15.2
(-10.6 to 41.0)
28.0
(3.3 to 52.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20mg Triamcinolone, 60mg Triamcinolone
Comments This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments Comparison 60mg vs. 20mg: F (1,36)=0.06, p=0.8
Method linear mixed model
Comments first order antedepentent covariance structure
Method of Estimation Estimation Parameter group x time interaction
Estimated Value 0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20mg Triamcinolone, 40mg Triamcinolone
Comments This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments Comparison 40mg vs. 20mg: F (1,35)=1.1, p=0.3
Method linear mixed model
Comments first order antedependent covariance structure
Method of Estimation Estimation Parameter group x time interaction
Estimated Value 1.7
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 20mg Triamcinolone 40mg Triamcinolone 60mg Triamcinolone
Hide Arm/Group Description Low dose group. Standard dose group High dose group
All-Cause Mortality
20mg Triamcinolone 40mg Triamcinolone 60mg Triamcinolone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
20mg Triamcinolone 40mg Triamcinolone 60mg Triamcinolone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)      1/10 (10.00%)    
Gastrointestinal disorders       
GI Illness requiring hospitalization [1]  0/9 (0.00%)  0 0/9 (0.00%)  0 1/10 (10.00%)  1
[1]
Subject hospitalized for gastrointestinal illness. Unrelated to study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
20mg Triamcinolone 40mg Triamcinolone 60mg Triamcinolone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)      0/10 (0.00%)    
The study was powered to detect differnces between high-dose and placebo, and standard-dose and placebo. The trial was altered due to ethical concerns for placebo injection due to apparent effectiveness in the literature. Low dose was substituted.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Richard Wilson
Organization: MetroHealth Medical Center
Phone: 216-957-3529
EMail: rwilson@metrohealth.org
Layout table for additonal information
Responsible Party: John Chae, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00597766     History of Changes
Other Study ID Numbers: K24HD054600 ( U.S. NIH Grant/Contract )
K24HD054600 ( U.S. NIH Grant/Contract )
First Submitted: January 9, 2008
First Posted: January 18, 2008
Results First Submitted: September 15, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017