Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms

Study Purpose

Rotator cuff tendinopathy, one of the pathologies identified as part of the cluster of shoulder symptoms known as subacromial pain syndrome, is a common musculoskeletal shoulder condition. Resolution of pain and disability is poor despite treatment, with only about 50% reporting full recovery at 12

- 18 months.

Prior studies suggest therapeutic exercise when used alone and with other interventions can have positive outcomes; however, not all patients with rotator cuff tendinopathy respond. Few studies have assessed the effects of exercise for individuals with chronic pain, especially brain driven mechanisms, thought to play a key role. In this study, we will use brain imaging to understand the mechanisms, identify predictors of a positive response to exercise, and the relationship to biomechanical and pain-related factors in patients with RC tendinopathy. The findings from this study will optimize the delivery and treatment response to exercise for individuals with shoulder pain.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 45 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. the clinical diagnosis for RC tendinopathy will be made with positive 3 of 5 tests: Hawkins-Kennedy, Neer, painful arc, empty can, external rotation resistance test. 2. pain ≥ 3/10 on a numeric pain rating scale. 3. age: 18

- 45 years.

4. Participant must read, sign and date the appropriate Informed consent document. 5. Participant BMI ≤ 30.

Exclusion Criteria:

1. Insufficient ability to comprehend and complete the questionnaires, 2. Inability to attend sessions, 3. Prior surgery of shoulder, neck or thoracic spine, 4. Primary complaint of neck or thoracic pain, 5. Diagnosis of cervical spinal stenosis, 6. Any serious spinal and shoulder pathology: infections, arthrosis, rheumatic disorders, acute fractures, shoulder dislocation, osteoporosis, or tumors, 7. Central Nervous System involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman and/or Babinski reflexes, 8. two or more neurologic signs of nerve root compression to include myotomal weakness, positive muscle stretch reflex, and dermatomal sensory loss, 9. any shoulder or arm pain with cervical spine tests of Spurling's Test, cervical rotation to the ipsilateral side, or axial compression test, or. 10. primary adhesive capsulitis defined by passive range of motion loss >50% as compared bilaterally of shoulder external rotation, internal rotation, or elevation. 11. Has a device or other condition that is not safe for MRI, including pacemakers.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04923477
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Southern California
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lori A Michener, PT, ATC, PhD
Principal Investigator Affiliation	University of Southern California
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rotator Cuff Tendinosis, Rotator Cuff Tendinitis, Rotator Cuff Injuries, Subacromial Pain Syndrome

Additional Details

Theoretical models propose the development of shoulder pain from an acute injury or repetitive motion seen in sports and certain work environments. Repetitive motions, in combination with altered muscle activity and altered movement strategies, may lead to damage of the rotator cuff structures resulting in local shoulder pain. Emerging evidence supports the hypothesis that localized pain may result in chronic centralized pain over time through central sensitization. Central nervous system changes, specifically those at the level of the brain have been shown to play a role in chronic pain. Neurophysiological mechanisms have been shown to predict symptom progression in other chronic pain conditions. Despite a large body of evidence that therapeutic exercise, mechanisms leading to pain relief are still not well understood. Studies identify a critical role of exercise in modulating excitation and inhibition of key pain centers in the central nervous systems. However, limited evidence exists as to the mechanisms of exercise in the management of patients with chronic pain with therapeutic exercise.

Arms & Interventions

Arms

Experimental: Exercise Group

Therapeutic exercise of resistance and mobility training delivered by a trained health professional x 8 weeks.

Interventions

Other: - Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome

Therapeutic exercise of resistance and mobility via a combination of HEP and in-person/virtual visits 5 days/ wk. Exercise program instruction in person, then 2-3 visits /wk x 8 wks (in-person or virtual) with a trained professional for the progression of exercises. Adherence to exercise will be measured daily via text and recorded in a mobile app. Patients will start with Phase 1 exercises of shoulder external & internal rotation, scapular stabilization, and active shoulder elevation; resistance levels of elastic bands will be assigned and progressed based on patient-reported shoulder pain and perceived difficulty. Patients will be advanced to Phase 2 when they complete Phase 1. The exercise protocol will be delivered with the methods previously published by Tate, 2010 and Mintken 2016.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory

Los Angeles, California, 90089

Site Contact

Oscar Villa Diequez, PT, MS

[email protected]

323-224-5032

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