Overview

This trial is active, not recruiting.

Conditions spinal cord injury, shoulder pain
Treatment shoulder home exercise program
Sponsor Rancho Research Institute, Inc.
Collaborator Rancho Los Amigos National Rehabilitation Center
Start date April 2012
End date July 2017
Trial size 166 participants
Trial identifier NCT02135978, H133N110018

Summary

The purpose of this study is to determine if a shoulder exercise program can prevent the onset of shoulder pain and improve community participation in persons who have a spinal cord injury (SCI). Upon entry into the study patients will have pain-free shoulders and will be followed for 3 years to determine rate of shoulder pain development. Patients will learn a simple shoulder home exercise program and will be instructed on techniques to protect their shoulder during wheelchair propulsion, transfers and activities of daily living. Patients will be instructed to perform the home exercise program 3 days per week. Two types of treatment (training) delivery approaches that have been documented to reduce chronic shoulder pain will be compared. The rate of shoulder pain development for the two groups will be compared to the rate of shoulder pain development in the historical control group. The investigators hypothesize that the rate of shoulder pain development will be lower in the experimental treatment groups compared to the historical control group. Any differences between the two treatment delivery approaches for the experimental treatment groups will help to provide guidelines for the most effective delivery approach of a shoulder pain prevention program.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Patients will attend two sessions of one-to-one training with a physical therapist to learn the shoulder home exercise program. The sessions are 4 weeks apart. They will also review a handout on techniques to protect their shoulder during wheelchair propulsion and transfers.
shoulder home exercise program
Patients receive instruction and practice on the shoulder home exercise program, receive a notebook with handouts including pictures and written instructions on how to perform the program, and receive a kit containing the exercise equipment. Patients are asked to perform the exercises at home 3 days a week over the next 3 years.
(Active Comparator)
Patients will attend four classes held each week for 4 consecutive weeks. The classes are led by a physical therapist and a peer mentor (with a spinal cord injury). Two to four research patients are in each class. Classes begin with an interactive education presentation on techniques and recommendations to protect the shoulder during transfers, wheelchair propulsion, raises and activities of daily living. This is followed by performance of the home exercise program. Patients will be called every 3 to 6 months by a peer mentor to receive encouragement, praise, and/or problem solve barriers to exercise.
shoulder home exercise program
Patients receive instruction and practice on the shoulder home exercise program, receive a notebook with handouts including pictures and written instructions on how to perform the program, and receive a kit containing the exercise equipment. Patients are asked to perform the exercises at home 3 days a week over the next 3 years.
(No Intervention)
Historical control group has received no intervention. Eligibility criteria, outcome measures and study duration for historical control group is matched for the experimental group and active comparator.

Primary Outcomes

Measure
Presence of shoulder pain
time frame: 36 month (3 year) evaluation time point

Secondary Outcomes

Measure
Activity levels
time frame: Baseline and every 2-3 months over the 3 year study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - spinal cord injury - at least 2 years duration post spinal cord injury and no greater than 20 years duration post spinal cord injury - at least 18 years of age - free of shoulder pain that interferes with daily activities or requires medical intervention at the time of enrollment in the study - a total score on the "Wheelchair User's Shoulder Pain Index" of 10 or less - adequate arm strength and movement to perform the shoulder exercise program Exclusion Criteria: - positive shoulder impingement signs (positive Hawkins-Kennedy test and painful arc in shoulder abduction or flexion) - biceps tendonitis (positive Speed's test) - adhesive capsulitis, or cervical radiculopathy - a history of shoulder injury or surgery or orthopedic or neurologic disorders (other than SCI) that would impact arm function

Additional Information

Official title Southern California Spinal Cord Injury Model System: A Randomized Clinical Trial to Evaluate Two Prevention Programs for Maintenance of Shoulder Health and Function After Spinal Cord Injury
Principal investigator Sara J Mulroy, PhD, PT
Description All persons are at risk for shoulder pain from a shoulder injury or rotator cuff injury. Persons with SCI are at a greater risk because of the increased use of their shoulders. Lifestyle changes following SCI place a large demand on an individual's shoulders. Pushing a wheelchair, transferring, and performing pressure relief raises are three common activities that put added strain on the shoulders. In addition to these activities, reaching from a wheelchair can put strain on the shoulder because many environments are not ideally set up for wheelchair users. These new stressors are believed by the medical community to lead to shoulder pain. The prevalence of shoulder pain for persons with spinal cord injury is 30-70%. Untreated, shoulder pain may lead to additional losses in function and community mobility. Previous research shows that shoulder exercises along with education on how to improve one's technique for wheelchair propulsion, transfers, and weight relief raises can significantly reduce chronic shoulder pain and improve quality of life. The investigators aim to not only reduce existing shoulder pain, but also to prevent the onset of new pain. The current study will teach the same 4 simple shoulder strengthening exercises performed in the prior study to patients with healthy shoulders. Half of the patients will receive 2 sessions of one-to-one training with a physical therapist, and the other half will receive 4 sessions of training combined with an interactive education program on techniques to protect their shoulder in a class format led by a physical therapist and a peer mentor with a spinal cord injury. Patients will be followed for 3 years to learn if they develop shoulder pain.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Rancho Research Institute, Inc..