Therapeutic Exercise for Rotator Cuff Tendinopathy

Overseen By Lori A Michener, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Prior surgery, Cervical stenosis, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome?

Research shows that exercise programs, including strengthening and flexibility exercises, can significantly improve shoulder pain and function in people with rotator cuff tendinopathy. These exercises are often as effective as surgery, and structured programs can be designed for home or clinic use, with benefits typically seen within 12 weeks. ^{1 2 3 4 5}

Is therapeutic exercise for rotator cuff tendinopathy safe for humans?

Therapeutic exercise for rotator cuff tendinopathy is generally considered safe for humans, as studies have shown it to be effective in improving shoulder pain and function without significant safety concerns. ^{1 6 7 8 9}

How is the treatment of therapeutic exercise for rotator cuff tendinopathy different from other treatments?

Therapeutic exercise for rotator cuff tendinopathy is unique because it can be tailored to individual needs, allowing for flexibility in whether exercises are done at home or in a clinic, and it emphasizes resistance and repetition without a strict optimal level. Unlike other treatments, it does not require pain avoidance during exercise, and it can be designed by physiotherapists with varying levels of experience. ^{1 5 6 8 9}

Research Team

Lori A Michener, PT, ATC, PhD

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for individuals aged 18-45 with a clinical diagnosis of rotator cuff tendinopathy, confirmed by specific shoulder tests. Participants must have shoulder pain rated at least 3/10 and a BMI ≤30. They should be able to attend sessions, sign consent forms, and safely undergo MRI scans. Exclusions include prior surgeries in the area, certain spinal conditions, inability to complete questionnaires, or any serious pathology affecting the spine or nervous system.

Inclusion Criteria

Participant must read, sign and date the appropriate Informed consent document

Participant BMI must be ≤ 30

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

Exclusion Criteria

Has a device or other condition that is not safe for MRI, including pacemakers

I have signs of nerve damage or issues with my central nervous system.

I do not have serious spine or shoulder conditions like infections, arthritis, fractures, dislocations, osteoporosis, or tumors.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Therapeutic exercise of resistance and mobility training delivered by a trained health professional

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

44 weeks

2 visits (in-person) at 26 and 52 weeks

Treatment Details

Interventions

• Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome

Trial Overview The study investigates how therapeutic exercise affects people with rotator cuff tendinopathy/subacromial pain syndrome. It aims to understand brain mechanisms behind exercise response using brain imaging and will explore predictors of positive outcomes while considering biomechanical and pain-related factors.

Participant Groups

Group I: Exercise Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Therapeutic exercise for rotator cuff tendinopathy: a systematic review of contextual factors and prescription parameters. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Progressive strengthening exercises for subacromial impingement syndrome. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A randomised controlled feasibility study investigating the use of eccentric and concentric strengthening exercises in the treatment of rotator cuff tendinopathy. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The role of progressive, therapeutic exercise in the management of upper limb tendinopathies: A systematic review and meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Isometric versus isotonic exercise in individuals with rotator cuff tendinopathy-Effects on shoulder pain, functioning, muscle strength, and electromyographic activity: A protocol for randomized clinical trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A prospective, double-blind, randomized clinical trial comparing subacromial injection of betamethasone and xylocaine to xylocaine alone in chronic rotator cuff tendinosis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise-Based Muscle Development Programmes and Their Effectiveness in the Functional Recovery of Rotator Cuff Tendinopathy: A Systematic Review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Exercise for rotator cuff tendinopathy: a systematic review. [2022]