Spinal Cord InjuryNCT02135978
Maintenance of Shoulder Health and Function After Spinal Cord Injury
A study testing Shoulder home exercise program in people with Spinal Cord Injury and Shoulder Pain, run by Rancho Research Institute, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Shoulder Pain
- What is being tested?
- Shoulder home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jul 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rancho Los Amigos National Rehabilitaiton Center
Downey, California, 90242
About this study
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
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.
Read the detailed 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.
- Conditions
- Spinal Cord Injury, Shoulder Pain
- Being tested
- Shoulder home exercise program
- Keywords
- Spinal Cord Injury, Shoulder Pain, Exercise
- Medical subject headings
- Spinal Cord Injuries, Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder home exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| One-to-one training group for shoulder home exercise program | 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. Receives: Other: Shoulder home exercise program |
| Enhanced training group for shoulder home exercise program | 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. Receives: Other: Shoulder home exercise program |
| Historical control group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of shoulder pain
Presence of shoulder pain will be measured using the "Wheelchair User's Shoulder Pain Index". This questionnaire uses a visual analog scale to rate level of shoulder pain during the previous week while performing 15 common daily activities such as transferring from the bed to a wheelchair or pushing a wheelchair > 10 minutes.
Measured: 36 month (3 year) evaluation time point
Secondary outcomes (1)
Activity levels
Patients will be called every 2-3 months to report the frequency and intensity of their shoulder exercise program. Patients will be asked questions about their arm use specific to their functional abilities during the previous 1 to 3 days, such as the number of transfers performed, number of depression raises performed, how often they use their arms for chores or use their arms to help with walking (if applicable). All patients with a manual wheelchair will have an odometer installed on their wheelchair and will report their distance and speed of wheelchair propulsion.
Measured: Baseline and every 2-3 months over the 3 year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startApr 2012
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rancho Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Rancho Los Amigos National Rehabilitation Center
- Responsible party
- Principal investigator, Sara Mulroy, Rancho Research Institute, Inc.
- Investigators
- Sara J Mulroy, PhD, PT, Principal investigator, Rancho Research Institute and Rancho Los Amigos National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135978
- Sponsor's protocol ID
- H133N110018
- Status last verified
- Apr 2018
- First submitted
- 6 May 2014
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mulroy SJ, Thompson L, Kemp B, Hatchett PP, Newsam CJ, Lupold DG, Haubert LL, Eberly V, Ge TT, Azen SP, Winstein CJ, Gordon J; Physical Therapy Clinical Research Network (PTClinResNet). Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011 Mar;91(3):305-24. doi: 10.2522/ptj.20100182. Epub 2011 Feb 3.
PubMed 21292803
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02135978
- Acronym / sponsor ID
- H133N110018
- Conditions
- Spinal Cord Injury, Shoulder Pain
- Keywords
- Spinal Cord Injury, Shoulder Pain, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Rancho Research Institute, Inc.University, hospital or other
- Collaborators
- Rancho Los Amigos National Rehabilitation Center
- Study start
- Apr 2012
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 May 2014 (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 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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One-to-one training group for shoulder home exercise program | Experimental | Other: Shoulder home exercise programPatients 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. |
| Enhanced training group for shoulder home exercise program | Active comparator | Other: Shoulder home exercise programPatients 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. |
| Historical control group | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 home exercise programPatients 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. | Other | Enhanced training group for shoulder home exercise program, One-to-one training group for shoulder home exercise program |
Primary outcome
Presence of shoulder pain
Time frame: 36 month (3 year) evaluation time point
Presence of shoulder pain will be measured using the "Wheelchair User's Shoulder Pain Index". This questionnaire uses a visual analog scale to rate level of shoulder pain during the previous week while performing 15 common daily activities such as transferring from the bed to a wheelchair or pushing a wheelchair > 10 minutes.
1 secondary outcome
Activity levels
Time frame: Baseline and every 2-3 months over the 3 year study
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 11 Apr 2018.
- Background: PubMed 21292803Mulroy SJ, Thompson L, Kemp B, Hatchett PP, Newsam CJ, Lupold DG, Haubert LL, Eberly V, Ge TT, Azen SP, Winstein CJ, Gordon J; Physical Therapy Clinical Research Network (PTClinResNet). Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011 Mar;91(3):305-24. doi: 10.2522/ptj.20100182. Epub 2011 Feb 3.
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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.
Sara J Mulroy, PhD, PT principal investigator
Rancho Research Institute and 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 study testing Shoulder home exercise program in people with Spinal Cord Injury and Shoulder Pain, run by Rancho Research Institute, Inc. 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 6 inclusion and 4 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 11 Apr 2018. 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.
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?
Presence of shoulder pain (time frame: 36 month (3 year) evaluation time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02135978, which also lists 1 linked publication.
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 11 Apr 2018.