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Therapeutic Exercise for Rotator Cuff Tendinopathy

N/A

Recruiting

Led By Lori A Michener, PT, ATC, PhD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pain level must be ≥ 3/10 on a numeric pain rating scale

Age must be between 18 and 45 years

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 weeks, 4 weeks, 8 weeks, 26 and 52 weeks.

Awards & highlights

Summary

This trial is testing whether therapeutic exercise can help people with rotator cuff tendinopathy, a common shoulder condition that often doesn't get better with treatment.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects from therapeutic exercises may include increased pain or discomfort in the affected area during or after exercises due to muscle fatigue or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pain level is 3 or higher on a scale of 0 to 10.

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I struggle to understand and fill out questionnaires.

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I have pain in my neck or upper back.

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I have had surgery on my shoulder, neck, or upper back.

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I cannot attend sessions in person.

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I have been diagnosed with narrowing of the spinal canal in my neck.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks, 4 weeks, 8 weeks, 26 and 52 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks, 4 weeks, 8 weeks, 26 and 52 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 4 weeks, 8 weeks, 26 and 52 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pennsylvania Shoulder Score (PENN)

Secondary outcome measures

Functional Magnetic Resonance Imaging (fMRI)

OSPRO- Yellow Flags

Pain pressure threshold (PPT)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Exercise GroupExperimental Treatment1 Intervention

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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

919 Previous Clinical Trials

1,611,381 Total Patients Enrolled

1 Trials studying Rotator Cuff Tears

116 Patients Enrolled for Rotator Cuff Tears

Lori A Michener, PT, ATC, PhDPrincipal InvestigatorUniversity of Southern California

Media Library

Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome Clinical Trial Eligibility Overview. Trial Name: NCT04923477 — N/A

Rotator Cuff Tears Research Study Groups: Exercise Group

Rotator Cuff Tears Clinical Trial 2023: Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome Highlights & Side Effects. Trial Name: NCT04923477 — N/A

Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome 2023 Treatment Timeline for Medical Study. Trial Name: NCT04923477 — N/A

Rotator Cuff Tears Patient Testimony for trial: Trial Name: NCT04923477 — N/A

~7 spots leftby Dec 2024

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