Study of Strengthening Exercises and Improving Movement for Painful Shoulders in Adults With Spinal Cord Injury

April 18, 2007 updated by: University of Southern California

Strengthening and Optimal Movements for Painful Shoulders in Chronic Spinal Cord Injury (STOMPS)

The purpose of this study is to conduct research to see if we can help people who have a spinal cord injury and shoulder pain to decrease the pain in the shoulders. We are investigating the effectiveness of a home exercise program for the shoulders and changes in how tasks are performed compared to an educational program on shoulder pain. There are no new experimental procedures included in this study; instead it is a comparison of two types of treatment that have been provided for this problem before. The new part of this study is the collecting of information before and after treatment. We hypothesize that those who participate in this home exercise program will have decrease shoulder pain and increase activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adults who sustain a spinal cord injury (SCI) now have the potential to lead active, productive lives with near normal life expectancy. Recent studies have demonstrated that many people with SCI develop health and functional problems at earlier ages than their non-disabled peers, with symptoms often occurring between the mid-30's and the mid-50's. These symptoms and impairments include: pain, musculoskeletal problems, declining energy, loss of strength and new functional limitations. These are examples of the challenges people may face as they reach mid-life with a SCI. A prevalent impairment in the long-term SCI population is upper extremity pain. Both the incidence and severity of pain increase with longer duration of SCI. The impact of shoulder pain on function and independence after SCI can be significant and detrimental. Development of shoulder pain in the SCI population has been associated with the increased weight-bearing demand placed on the upper extremities for mobility, muscle imbalances in the shoulder girdle, poor postural alignment from trunk paralysis and the need to function from a seated position. The efficacy of specific interventions has not been fully investigated. Treatment effectiveness must be determined using measures that include the pain impairment (severity), the disability or functional limitation associated with pain, and the participation or handicap limitations associated with pain. The goal is to develop a program that has standardized resistance, requires little equipment, is simple to conduct and minimizes the time commitment required of the patient. The effect of the combined intervention on shoulder pain and function will be assessed with a randomized clinical trial comparing the intervention to an attention control group receiving generalized information regarding shoulder joint anatomy and pain management. Secondary goals of this study are to identify the critical muscle groups for which strength changes are associated with shoulder pain reduction and to determine the impact of the intervention on physical activity, health related quality of life and overall subjective quality of life.

Study Type

Interventional

Enrollment

80

Phase

  • Phase 1

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
    • California
      • Downey, California, United States, 90242
        • Rancho Los Amigos National Rehabilitation Hospital

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

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • post-pubescent (age 14 or older) onset of paraplegia,
  • at least 5 years duration with spinal cord injury, current age between 19 and 75,
  • unilateral or bilateral shoulder pain that interferes with at least one functional task (e.g. transfers, wheelchair propulsion),
  • subjects who propel a manual wheelchair >50% normalized velocity and ability to understand the informed consent.

Exclusion Criteria:

  • hospitalization within the last month
  • a cortisone injection to the shoulder within the last 4 months,
  • a fracture within the last year,
  • shoulder surgery to the painful side within the last year,
  • a diagnosis of complete rotator cuff tear, rheumatoid arthritis, adhesive capsulitis at the shoulder or complex regional pain syndrome (also known as reflex sympathetic dystrophy),
  • any serious medical conditions, major depression, alcohol abuse, or being unlikely to complete the 12-weeks of treatment.

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: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
shoulder pain as measured by Wheelchair Users Shoulder Pain Index (WUSPI)

Secondary Outcome Measures

Outcome Measure
General shoulder pain measured by a visual analog scale (VAS)from the McGill Short Form Pain Questionnaire
Shoulder torque with a hand held dynamometer
Subject's activity level with the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Community involvement with the Community Activities Checklist (CAC)
Quality of life with the SF-36 Health Related Quality of Life questionnaire
Quality of life with the Subjective Quality of Life Scale (SQOL)
Wheelchair propulsion

Collaborators and Investigators

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

Sponsor

University of Southern California

Collaborators

Physical Therapy Clinical Research Network

Investigators

  • Principal Investigator: Bryan Kemp, Ph.D, Rancho Los Amigos National Rehabilitation Center
  • Principal Investigator: Carolee J. Winstein, Ph.D., PT, University of Southern California
  • Principal Investigator: Sara Mulroy, Ph.D., PT, Rancho Los Amigos National Rehabilitation Center

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

March 1, 2004

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

April 16, 2007

First Submitted That Met QC Criteria

April 16, 2007

First Posted (Estimate)

April 18, 2007

Study Record Updates

Last Update Posted (Estimate)

April 19, 2007

Last Update Submitted That Met QC Criteria

April 18, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-025022

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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