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

NCT ID: NCT00461474

Last Updated: 2007-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2006-03-31

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.

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Shoulder strengthening exercises

Intervention Type: BEHAVIORAL

Movement Optimization

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Physical Therapy Clinical Research Network

NETWORK

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Principal Investigators

Bryan Kemp, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Rancho Los Amigos National Rehabilitation Center

Carolee J. Winstein, Ph.D., PT

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Sara Mulroy, Ph.D., PT

Role: PRINCIPAL_INVESTIGATOR

Rancho Los Amigos National Rehabilitation Center

Locations

Rancho Los Amigos National Rehabilitation Hospital

Downey, California, United States

Countries

United States

Other Identifiers

HS-025022

Identifier Type: -

Identifier Source: org_study_id