Recruiting

Therapeutic Exercise

Sponsor:

University of Southern California

Code:

NCT04923477

Conditions

Rotator Cuff Tendinosis

Rotator Cuff Tendinitis

Rotator Cuff Injuries

Subacromial Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome

Study Details

Brief summary:

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.

Conditions

Rotator Cuff Tendinosis

Rotator Cuff Tendinitis

Rotator Cuff Injuries

Subacromial Pain Syndrome

Study ID

NCT04923477

Start date

Jun 8, 2021

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise Group

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

Interventions

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 measure

  • Pennsylvania Shoulder Score (PENN) [ Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 26 weeks and 52 weeks ]

Central Contacts and Locations

Central contacts

Lori A Michener, PT, ATC, PhD

323-224-5032lmichene@usc.edu

Locations

Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory

Recruiting

Los Angeles, California, United States, 90089

Contacts

Principal Investigator:

Lori A Michener, PhD

More Information

Sponsor

University of Southern California

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-02-03.