Trial for Shoulder Pathology and Pain in Chronic SCI

September 12, 2022 updated by: Elizabeth Roy Felix, University of Miami
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: shoulder exercise
Exercises performed 3 times a week for 12 weeks
Active Comparator: 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
Behavioral: education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in shoulder pathology
Time Frame: Baseline to week 12
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
Time Frame: Baseline to week 12
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
Time Frame: Baseline to week 16
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
Time Frame: Baseline to week 12
Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)
Baseline to week 12
Change in shoulder pain using the WUSPI
Time Frame: Baseline to week 16
Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)
Baseline to week 16
Change in shoulder pathology
Time Frame: Baseline to week 16
Quantitative ultrasound measures of the supraspinatus tendon
Baseline to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

U.S. Department of Education

Investigators

  • Principal Investigator: Elizabeth R Felix, PhD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2012

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

August 31, 2016

Study Registration Dates

First Submitted

April 29, 2018

First Submitted That Met QC Criteria

April 29, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20111005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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