NCT04923477 · University of Southern California
Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Pennsylvania Shoulder Score (PENN)
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 26 weeks and 52 weeks
The PENN is a self-report measure of pain, satisfaction with shoulder use, and function. The pain section has 3 questions of pain at rest, with normal daily activities, and with strenuous activities. The disability section has 20 items rated on a 4-category Likert scale for difficulty (0=cannot do at all, 1=much difficulty, 2=some difficulty, 3=no difficulty, and x=did not do before injury). The satisfaction section is 1 question, rating satisfaction with shoulder use on a 0-10 numeric scale (10 = fully satisfied).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- pain ≥ 3/10 on a numeric pain rating scale
- age: 18 - 45 years
- Participant must read, sign and date the appropriate Informed consent document.
- Participant BMI ≤ 30
Exclusion criteria
- Insufficient ability to comprehend and complete the questionnaires,
- Inability to attend sessions,
- Prior surgery of shoulder, neck or thoracic spine,
- Primary complaint of neck or thoracic pain,
- Diagnosis of cervical spinal stenosis,
- Any serious spinal and shoulder pathology: infections, arthrosis, rheumatic disorders, acute fractures, shoulder dislocation, osteoporosis, or tumors,
- 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,
- two or more neurologic signs of nerve root compression to include myotomal weakness, positive muscle stretch reflex, and dermatomal sensory loss,
- any shoulder or arm pain with cervical spine tests of Spurling's Test, cervical rotation to the ipsilateral side, or axial compression test, or
- primary adhesive capsulitis defined by passive range of motion loss \>50% as compared bilaterally of shoulder external rotation, internal rotation, or elevation.
- Has a device or other condition that is not safe for MRI, including pacemakers.
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 3, 2026 · Source of record for eligibility and locations