Trial for Shoulder Pathology and Pain in Chronic SCI

Not Applicable

Completed

• Conditions: Shoulder Pain
• Interventions: Behavioral: education; Behavioral: shoulder exercise

• Registration Number: NCT03521856
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-05-02
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Study First Submitted: 2018-04-29
• Study First Submitted QC: 2018-04-29
• Study First Posted: 2018-05-11
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Candidates will be men or women, 18 years of age or older.
2. Candidates must have an SCI and be at least 1 year post-diagnosis
3. Candidates must use a wheelchair (manual or electric) for at least the majority of the time.
4. Candidates must be able to transfer themselves without the help of others.
5. 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.

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Exclusion Criteria

1. Patients younger than 18 years of age.
2. Patients who have a history of pre-injury rotator cuff tears or shoulder injury.
3. Patients who do not use a wheelchair (manual or electric) at least 50% of the time.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
education-only control	education	Subjects watched a 1 hour educational video on shoulder anatomy, mechanisms of shoulder injury and pain, and hints for managing shoulder pain
shoulder exercise intervention	shoulder exercise	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.

Primary Outcome Measures

Name	Time	Method
Change in shoulder pathology	Baseline to week 12	Quantitative ultrasound measures of the supraspinatus tendon

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States