Shoulder PainPhase 1NCT00461474
Study of Strengthening Exercises and Improving Movement for Painful Shoulders in Adults With Spinal Cord Injury
A Phase 1 study testing Shoulder strengthening exercises and Movement Optimization in people with Shoulder Pain, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Shoulder strengthening exercises and Movement Optimization
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Mar 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rancho Los Amigos National Rehabilitation Hospital
Downey, California, 90242
About this study
Official title: Strengthening and Optimal Movements for Painful Shoulders in Chronic Spinal Cord Injury (STOMPS)
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.
Read the 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
- Being tested
- Shoulder strengthening exercises, Movement Optimization
- Keywords
- Shoulder pain, Chronic Spinal Cord Injury, Exercise, Physical therapy techniques, Motor performance
- Medical subject headings
- Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder strengthening exercisesBehavioural
Movement OptimizationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Quality of life with the Subjective Quality of Life Scale (SQOL)
Wheelchair propulsion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startMar 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Physical Therapy Clinical Research Network
- Investigators
- Bryan Kemp, Ph.D, Principal investigator, Rancho Los Amigos National Rehabilitation CenterCarolee J. Winstein, Ph.D., PT, Principal investigator, University of Southern CaliforniaSara Mulroy, Ph.D., PT, Principal investigator, Rancho Los Amigos National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461474
- Sponsor's protocol ID
- HS-025022
- Status last verified
- Apr 2007
- First submitted
- 16 Apr 2007
- Last updated
- 19 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening and Optimal Movements for Painful Shoulders in Chronic Spinal Cord Injury (STOMPS)
- ClinicalTrials.gov ID
- NCT00461474
- Acronym / sponsor ID
- HS-025022
- Conditions
- Shoulder Pain
- Keywords
- Shoulder pain, Chronic Spinal Cord Injury, Exercise, Physical therapy techniques, Motor performance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Physical Therapy Clinical Research Network
- Study start
- Mar 2004
- Study completion
- Mar 2006 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder strengthening exercises | Behavioural | – |
| Movement Optimization | Behavioural | – |
Primary outcome
shoulder pain as measured by Wheelchair Users Shoulder Pain Index (WUSPI)
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Kemp, Ph.D principal investigator
Rancho Los Amigos National Rehabilitation Center
Carolee J. Winstein, Ph.D., PT principal investigator
University of Southern California
Sara Mulroy, Ph.D., PT principal investigator
Rancho Los Amigos National Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Shoulder strengthening exercises and Movement Optimization in people with Shoulder Pain, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder pain as measured by Wheelchair Users Shoulder Pain Index (WUSPI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2007.