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

NCT04923477 | Recruiting

• 1 other identifier: HS-20-00994
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pennsylvania Shoulder Score (PENN)

  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).

  Baseline, 2 weeks, 4 weeks, 8 weeks, 26 weeks and 52 weeks

Secondary Outcomes (4)

• Functional Magnetic Resonance Imaging (fMRI)

  Baseline, 2 weeks, 4 weeks, and 8 weeks

• Shoulder Kinematics and Muscle Activity

  Baseline, 2 weeks, 4 weeks, and 8 weeks

• Pain pressure threshold (PPT)

  Baseline, 2 weeks, 4 weeks, and 8 weeks

• OSPRO- Yellow Flags

  Baseline, 2 weeks, 4 weeks, 8 weeks, 26 and 52 weeks.

Study Arms (1)

Exercise Group

EXPERIMENTAL

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

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

Interventions

Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome OTHER

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.

Exercise Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory

Los Angeles, California, 90089, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Lori A Michener, PT, ATC, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori A Michener, PT, ATC, PhD

CONTACT

323-224-5032; lmichene@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The proposed research will be a prospective longitudinal cohort laboratory experimental design to examine mechanisms of a single bout and 2, 4, and 8 weeks of therapeutic exercise in participants with rotator cuff tendinopathy

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 11, 2021
• Study Start: June 8, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)