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

This study has been completed.
Sponsor:
Collaborator:
Physical Therapy Clinical Research Network
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00461474
First received: April 16, 2007
Last updated: April 18, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Shoulder Pain
Behavioral: Shoulder strengthening exercises
Behavioral: Movement Optimization
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Strengthening and Optimal Movements for Painful Shoulders in Chronic Spinal Cord Injury (STOMPS)

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • shoulder pain as measured by Wheelchair Users Shoulder Pain Index (WUSPI)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 80
Study Start Date: March 2004
Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461474

Locations
United States, California
Rancho Los Amigos National Rehabilitation Hospital
Downey, California, United States, 90242
Sponsors and Collaborators
University of Southern California
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00461474     History of Changes
Other Study ID Numbers: HS-025022
Study First Received: April 16, 2007
Last Updated: April 18, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Shoulder pain
Chronic Spinal Cord Injury
Exercise
Physical therapy techniques
Motor performance

Additional relevant MeSH terms:
Shoulder Pain
Spinal Cord Injuries
Wounds and Injuries
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 22, 2014