Shoulder PainNCT02777281
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
A study testing Shoulder pain and SCI and Shoulder pain and able bodies in people with Shoulder Pain and Spinal Cord Injury, run by University of Minnesota at 1 site in United States.
Trial summary
This study will compare two exercise programs in an interventional study for manual wheelchair users with spinal cord injury and shoulder pain. Subjects without spinal cord injury will also be enrolled to compare exercise approaches. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Shoulder Pain, Spinal Cord Injury
- What is being tested?
- Shoulder pain and SCI and Shoulder pain and able bodies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 1 Dec 2023
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Persons with paraplegia at least 1 year post SCI. Prior to this time patients are still adjusting to independent function with manual wheelchairs as their primary means of mobility. This criteria ensures the subjects have had sufficient exposure to the functional demands associated with their condition.
- Age 21 to 60 years old; below age 21, particularly in males, the humeral growth plate may not have fully closed. Including subjects above this age ensures skeletal maturity. After age 60, even in able-bodied individuals, substantial degenerative changes can begin to occur in the shoulder joint.
- Use of a manual wheelchair as the primary means of mobility (> 50% time). This is the population with most risk of development of shoulder pain and associated secondary complications.
- A history of unilateral or bilateral shoulder pain that interferes with at least one functional task. Symptoms localized to the proximal anterior, lateral, or posterior glenohumeral (shoulder joint) region are required. Rotator cuff tendinopathy and "impingement" syndromes involve localized pain in this region. More diffuse symptoms are consistent with combined shoulder/neck syndromes or radiating pain from cervical spine pathology.
Who cannot join
- Inability to provide informed consent.
- Reproduction of shoulder pain, pain radiating down the upper extremity, numbness or tingling in the upper extremity, or other upper extremity symptoms during a cervical screening examination or thoracic outlet testing. This result would be indicative of primary cervical or thoracic outlet pathology.
- Shoulder pain of traumatic origin. Cumulative trauma disorders are of primary interest and most amenable to the proposed exercise interventions.
- History of shoulder surgery or dislocation.
- Recent history of fracture (within 1 year), hospitalization (within the past month), or cortisone injection to the shoulder (within 4 months). These conditions may interfere with safe or effective completion of the exercise intervention.
- A diagnosis or imaging findings of rheumatoid arthritis, end stage osteoarthritis, full thickness rotator cuff tear, adhesive capsulitis, or complex regional pain syndrome. These subjects may have joint disease progression that is severe, or not appropriately treated with a stretching and strengthening intervention.
- Diagnosed major depression, alcohol or substance abuse, or other serious medical conditions. These conditions may prevent subjects from regularly completing the exercise intervention
- All criteria apply to both groups excepting manual wheelchair use and SCI criteria not applicable to the able bodied subject group.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
This study will compare two exercise programs in an interventional study for manual wheelchair users with spinal cord injury and shoulder pain. Subjects without spinal cord injury will also be enrolled to compare exercise approaches.
Read the detailed description
The investigators hypothesis is that the biomechanically based exercise program will demonstrate greater muscle activation of targeted muscles, and reduced compression risk to the rotator cuff tendons.
- Conditions
- Shoulder Pain, Spinal Cord Injury
- Being tested
- Shoulder pain and SCI, Shoulder pain and able bodies
- Keywords
- Shoulder Pain, Wheelchair, Spinal Cord injury
- 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 pain and SCIBehavioural
Shoulder pain and SCI
Shoulder pain and able bodiesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Shoulder pain and SCI | Other | Manual wheelchair users with SCI Receives: Behavioral: Shoulder pain and SCI |
| Shoulder pain and able bodies | Other | No SCI or wheelchair use but presence of shoulder pain Receives: Behavioral: Shoulder pain and able bodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activity
Muscle activity during exercises is measured as a change in EMG
Measured: baseline
Rotator cuff compression risk
Motion and position data of the upper arm relative to the shoulder blade measured in degrees
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startSep 2015
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
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.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula M Ludewig, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777281
- Sponsor's protocol ID
- 1405M50661
- Status last verified
- Jan 2024
- First submitted
- 14 May 2014
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
- ClinicalTrials.gov ID
- NCT02777281
- Acronym / sponsor ID
- 1405M50661
- Conditions
- Shoulder Pain, Spinal Cord Injury
- Keywords
- Shoulder Pain, Wheelchair, Spinal Cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 19 May 2016 (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.
This study will compare two exercise programs in an interventional study for manual wheelchair users with spinal cord injury and shoulder pain. Subjects without spinal cord injury will also be enrolled to compare exercise approaches.
Detailed description
The investigators hypothesis is that the biomechanically based exercise program will demonstrate greater muscle activation of targeted muscles, and reduced compression risk to the rotator cuff tendons.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder pain and SCI | Other | Behavioral: Shoulder pain and SCIManual wheelchair users with SCI |
| Shoulder pain and able bodies | Other | Behavioral: Shoulder pain and able bodiesNo SCI or wheelchair use but presence of shoulder pain |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Persons with paraplegia at least 1 year post SCI. Prior to this time patients are still adjusting to independent function with manual wheelchairs as their primary means of mobility. This criteria ensures the subjects have had sufficient exposure to the functional demands associated with their condition.
- Age 21 to 60 years old; below age 21, particularly in males, the humeral growth plate may not have fully closed. Including subjects above this age ensures skeletal maturity. After age 60, even in able-bodied individuals, substantial degenerative changes can begin to occur in the shoulder joint.
- Use of a manual wheelchair as the primary means of mobility (> 50% time). This is the population with most risk of development of shoulder pain and associated secondary complications.
- A history of unilateral or bilateral shoulder pain that interferes with at least one functional task. Symptoms localized to the proximal anterior, lateral, or posterior glenohumeral (shoulder joint) region are required. Rotator cuff tendinopathy and "impingement" syndromes involve localized pain in this region. More diffuse symptoms are consistent with combined shoulder/neck syndromes or radiating pain from cervical spine pathology.
Key exclusion criteria (8 listed)
- Inability to provide informed consent.
- Reproduction of shoulder pain, pain radiating down the upper extremity, numbness or tingling in the upper extremity, or other upper extremity symptoms during a cervical screening examination or thoracic outlet testing. This result would be indicative of primary cervical or thoracic outlet pathology.
- Shoulder pain of traumatic origin. Cumulative trauma disorders are of primary interest and most amenable to the proposed exercise interventions.
- History of shoulder surgery or dislocation.
- Recent history of fracture (within 1 year), hospitalization (within the past month), or cortisone injection to the shoulder (within 4 months). These conditions may interfere with safe or effective completion of the exercise intervention.
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 pain and SCIShoulder pain and SCI | Behavioural | Shoulder pain and SCI |
| Shoulder pain and able bodies | Behavioural | Shoulder pain and able bodies |
Primary outcome
Muscle activity
Time frame: baseline
Muscle activity during exercises is measured as a change in EMG
Rotator cuff compression risk
Time frame: baseline
Motion and position data of the upper arm relative to the shoulder blade measured in degrees
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 5 Jan 2024.
Related trials for Shoulder Pain
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
Active, not recruiting
Effects of Scapular Stabilization on Rotator Cuff Strength, Shoulder Pain, Ansd Function
Shoulder Pain and Stiffness
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.
Paula M Ludewig, PhD principal investigator
University of Minnesota
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 pain and SCI and Shoulder pain and able bodies in people with Shoulder Pain and Spinal Cord Injury, run by University of Minnesota 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 8 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 5 Jan 2024. 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?
Muscle activity (time frame: baseline). The study lists 2 primary outcomes in all. 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 5 Jan 2024; AzTrials last refreshed its copy on 1 Nov 2026.