Study of Strengthening Exercises and Improving Movement for Painful Shoulders in Adults With Spinal Cord Injury
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Shoulder strengthening exercises
Movement Optimization
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder pain, Chronic Spinal Cord Injury, Exercise, Physical therapy techniques, Motor performance
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.
Sites / Locations
- Rancho Los Amigos National Rehabilitation Hospital
Outcomes
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
Full Information
NCT ID
NCT00461474
First Posted
April 16, 2007
Last Updated
April 18, 2007
Sponsor
University of Southern California
Collaborators
Physical Therapy Clinical Research Network
1. Study Identification
Unique Protocol Identification Number
NCT00461474
Brief Title
Study of Strengthening Exercises and Improving Movement for Painful Shoulders in Adults With Spinal Cord Injury
Official Title
Strengthening and Optimal Movements for Painful Shoulders in Chronic Spinal Cord Injury (STOMPS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Southern California
Collaborators
Physical Therapy Clinical Research Network
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Shoulder pain, Chronic Spinal Cord Injury, Exercise, Physical therapy techniques, Motor performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Shoulder strengthening exercises
Intervention Type
Behavioral
Intervention Name(s)
Movement Optimization
Primary Outcome Measure Information:
Title
shoulder pain as measured by Wheelchair Users Shoulder Pain Index (WUSPI)
Secondary Outcome Measure Information:
Title
General shoulder pain measured by a visual analog scale (VAS)from the McGill Short Form Pain Questionnaire
Title
Shoulder torque with a hand held dynamometer
Title
Subject's activity level with the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Title
Community involvement with the Community Activities Checklist (CAC)
Title
Quality of life with the SF-36 Health Related Quality of Life questionnaire
Title
Quality of life with the Subjective Quality of Life Scale (SQOL)
Title
Wheelchair propulsion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Kemp, Ph.D
Organizational Affiliation
Rancho Los Amigos National Rehabilitation Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolee J. Winstein, Ph.D., PT
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara Mulroy, Ph.D., PT
Organizational Affiliation
Rancho Los Amigos National Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Los Amigos National Rehabilitation Hospital
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Strengthening Exercises and Improving Movement for Painful Shoulders in Adults With Spinal Cord Injury
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