Trial for Shoulder Pathology and Pain in Chronic SCI

Study Overview
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Brief Summary
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This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. The research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.

Official Title
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Trial for Shoulder Pathology and Pain in Chronic SCI

Conditions
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Shoulder Pain

Intervention / Treatment
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* Behavioral: shoulder exercise
* Behavioral: education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates will be men or women, 18 years of age or older. Candidates must have an SCI and be at least 1 year post-diagnosis Candidates must use a wheelchair (manual or electric) for at least the majority of the time. Candidates must be able to transfer themselves without the help of others. The presence of at least moderate shoulder pain (rating of >= 4 on a 0-10 rating scale for average pain intensity) for 3 or more months. Exclusion Criteria: Patients younger than 18 years of age. Patients who have a history of pre-injury rotator cuff tears or shoulder injury. Patients who do not use a wheelchair (manual or electric) at least 50% of the time.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: shoulder exercise intervention<br>A home exercise intervention for strengthening and stretching the shoulders - Strengthening and Optimal Movement for Painful Shoulders (STOMPS) - performed 3 times per week for 12 weeks. | Behavioral: shoulder exercise<br>* Exercises performed 3 times a week for 12 weeks<br>|
| Active Comparator: education-only control<br>Subjects watched a 1 hour educational video on shoulder anatomy, mechanisms of shoulder injury and pain, and hints for managing shoulder pain | Behavioral: education<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in shoulder pathology | Quantitative ultrasound measures of the supraspinatus tendon | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in shoulder pain using the numerical rating scale | Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable) | Baseline to week 12 | 
| Change in shoulder pain using the numerical rating scale | Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable) | Baseline to week 16 | 
| Change in shoulder pain using the WUSPI | Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150) | Baseline to week 12 | 
| Change in shoulder pain using the WUSPI | Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150) | Baseline to week 16 | 
| Change in shoulder pathology | Quantitative ultrasound measures of the supraspinatus tendon | Baseline to week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injuries, SCI