Shoulder PainNCT03521856
Trial for Shoulder Pathology and Pain in Chronic SCI
A study testing shoulder exercise and education in people with Shoulder Pain, run by University of Miami at 1 site in United States.
Trial summary
This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- shoulder exercise and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2012to 31 Aug 2016
- 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
- Candidates will be men or women, 18 years of age or older.
- Candidates must have an SCI and be at least 1 year post-diagnosis
- Candidates must use a wheelchair (manual or electric) for at least the majority of the time.
- Candidates must be able to transfer themselves without the help of others.
- The presence of at least moderate shoulder pain (rating of >= 4 on a 0-10 rating scale for average pain intensity) for 3 or more months.
Who cannot join
- Patients younger than 18 years of age.
- Patients who have a history of pre-injury rotator cuff tears or shoulder injury.
- Patients who do not use a wheelchair (manual or electric) at least 50% of the time.
Trial locations and contacts
1 site in 1 country.
About this study
This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. The research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.
- Conditions
- Shoulder Pain
- Being tested
- shoulder exercise, education
- Keywords
- spinal cord injuries, SCI
- Medical subject headings
- Shoulder Pain, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shoulder exerciseBehavioural
Exercises performed 3 times a week for 12 weeks
educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| shoulder exercise intervention | Experimental | A home exercise intervention for strengthening and stretching the shoulders - Strengthening and Optimal Movement for Painful Shoulders (STOMPS) - performed 3 times per week for 12 weeks. Receives: Behavioral: shoulder exercise |
| education-only control | Active comparator | Subjects watched a 1 hour educational video on shoulder anatomy, mechanisms of shoulder injury and pain, and hints for managing shoulder pain Receives: Behavioral: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in shoulder pathology
Quantitative ultrasound measures of the supraspinatus tendon
Measured: Baseline to week 12
Secondary outcomes (5)
Change in shoulder pain using the numerical rating scale
Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)
Measured: Baseline to week 12
Change in shoulder pain using the numerical rating scale
Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)
Measured: Baseline to week 16
Change in shoulder pain using the WUSPI
Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)
Measured: Baseline to week 12
Change in shoulder pain using the WUSPI
Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)
Measured: Baseline to week 16
Change in shoulder pathology
Quantitative ultrasound measures of the supraspinatus tendon
Measured: Baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start2 May 2012
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Elizabeth Roy Felix, University of Miami
- Investigators
- Elizabeth R Felix, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521856
- Sponsor's protocol ID
- 20111005
- Status last verified
- Sep 2022
- First submitted
- 29 Apr 2018
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 21292803Cardenas DD, Felix ER, Cowan R, Orell MF, Irwin R. Effects of Home Exercises on Shoulder Pain and Pathology in Chronic Spinal Cord Injury: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2020 Jun;99(6):504-513. doi: 10.1097/PHM.0000000000001362.
PubMed 31851011
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial for Shoulder Pathology and Pain in Chronic SCI
- ClinicalTrials.gov ID
- NCT03521856
- Acronym / sponsor ID
- 20111005
- Conditions
- Shoulder Pain
- Keywords
- spinal cord injuries, SCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- 2 May 2012 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 11 May 2018 (actual)
- 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.
This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. The research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shoulder exercise intervention | Experimental | Behavioral: shoulder exerciseA home exercise intervention for strengthening and stretching the shoulders - Strengthening and Optimal Movement for Painful Shoulders (STOMPS) - performed 3 times per week for 12 weeks. |
| education-only control | Active comparator | Behavioral: educationSubjects watched a 1 hour educational video on shoulder anatomy, mechanisms of shoulder injury and pain, and hints for managing shoulder pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidates will be men or women, 18 years of age or older.
- Candidates must have an SCI and be at least 1 year post-diagnosis
- Candidates must use a wheelchair (manual or electric) for at least the majority of the time.
- Candidates must be able to transfer themselves without the help of others.
- The presence of at least moderate shoulder pain (rating of >= 4 on a 0-10 rating scale for average pain intensity) for 3 or more months.
Key exclusion criteria (3 listed)
- Patients younger than 18 years of age.
- Patients who have a history of pre-injury rotator cuff tears or shoulder injury.
- Patients who do not use a wheelchair (manual or electric) at least 50% of the time.
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 exerciseExercises performed 3 times a week for 12 weeks | Behavioural | shoulder exercise intervention |
| education | Behavioural | education-only control |
Primary outcome
Change in shoulder pathology
Time frame: Baseline to week 12
Quantitative ultrasound measures of the supraspinatus tendon
5 secondary outcomes
Change in shoulder pain using the numerical rating scale
Time frame: Baseline to week 12
Change in shoulder pain using the numerical rating scale
Time frame: Baseline to week 16
Change in shoulder pain using the WUSPI
Time frame: Baseline to week 12
Change in shoulder pain using the WUSPI
Time frame: Baseline to week 16
Change in shoulder pathology
Time frame: Baseline to week 16
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 16 Sep 2022.
- 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.
- Results publication: PubMed 31851011Cardenas DD, Felix ER, Cowan R, Orell MF, Irwin R. Effects of Home Exercises on Shoulder Pain and Pathology in Chronic Spinal Cord Injury: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2020 Jun;99(6):504-513. doi: 10.1097/PHM.0000000000001362.
- Individual participant dataSharing planned: No
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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.
Elizabeth R Felix, PhD principal investigator
University of Miami
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 exercise and education in people with Shoulder Pain, run by University of Miami 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 5 inclusion and 3 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 16 Sep 2022. 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?
Change in shoulder pathology (time frame: Baseline to week 12). 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 NCT03521856, which also lists 2 linked publications.
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 16 Sep 2022.