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

NCT00461474 | Completed Phase 1 DMC

• 1 other identifier: HS-025022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Pain

Keywords

Shoulder pain; Chronic Spinal Cord Injury; Exercise; Physical therapy techniques; Motor performance

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

• 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

Interventions

Shoulder strengthening exercises BEHAVIORAL

Movement Optimization BEHAVIORAL

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Physical Therapy Clinical Research Network: collaborator

Study Sites (1)

Rancho Los Amigos National Rehabilitation Hospital

Downey, California, 90242, United States

Location

MeSH Terms

Conditions

Shoulder Pain; Motor Activity

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: March 1, 2004
• Study Completion: March 1, 2006
• Last Updated: April 19, 2007

Record last verified: 2007-04

Locations

US (1)