Trial for Shoulder Pathology and Pain in Chronic SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-02

Study Completion Date

2016-08-31

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.

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Detailed Description

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Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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shoulder exercise intervention

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.

Group Type EXPERIMENTAL

shoulder exercise

Intervention Type BEHAVIORAL

Exercises performed 3 times a week for 12 weeks

education-only control

Subjects watched a 1 hour educational video on shoulder anatomy, mechanisms of shoulder injury and pain, and hints for managing shoulder pain

Group Type ACTIVE_COMPARATOR

education

Intervention Type BEHAVIORAL

Interventions

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shoulder exercise

Exercises performed 3 times a week for 12 weeks

Intervention Type BEHAVIORAL

education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No