- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04923477
Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms
Mechanisms of Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lori A Michener, PT, ATC, PhD
- Phone Number: 323-224-5032
- Email: lmichene@usc.edu
Study Locations
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California
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Los Angeles, California, United States, 90089
- Recruiting
- Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory
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Contact:
- Oscar Villa Diequez, PT, MS
- Phone Number: 323-224-5032
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Principal Investigator:
- Lori A Michener, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise Group
Therapeutic exercise of resistance and mobility training delivered by a trained health professional x 8 weeks.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
Baseline, 2 weeks, 4 weeks, 8 weeks, 26 weeks and 52 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Magnetic Resonance Imaging (fMRI)
Time Frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
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A high resolution structural image will be acquired from each participant with a magnetization-prepared rapid gradient-echo (MP-RAGE) sequence, with a repetition time (TR) = 2200 ms, echo time (TE) = 3.26 ms, slice thickness = 1 mm, 176 slices, 256 × 256 voxel matrices, and 13 mm voxel size.
Resting state scans will be acquired while participants rest with eyes closed for 10 min in 40-slice whole brain volumes, with slice thickness = 4 mm, TR = 2000 ms, TE = 28 ms, and flip angle = 77°.
Imaging during the rotator cuff muscle activation will be performed by having the participant perform muscle activation tasks for the deltoid and rotator cuff while lying supine in the MRI scanner.
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Baseline, 2 weeks, 4 weeks, and 8 weeks
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Shoulder Kinematics and Muscle Activity
Time Frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
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Shoulder kinematics of the humerus, thorax, and scapula will be assessed.
Muscle activity will be assessed of the rotator cuff (supraspinatus and infraspinatus), deltoid, upper, lower, and middle trapezius, and serratus anterior muscles.
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Baseline, 2 weeks, 4 weeks, and 8 weeks
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Pain pressure threshold (PPT)
Time Frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
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PPT will be measured using a mechanical pressure algometer (Wagner Instruments, Greenwich, CT) with a flat rubber covered 1 cm2 round force gage over the bilateral deltoids and anterior tibias
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Baseline, 2 weeks, 4 weeks, and 8 weeks
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OSPRO- Yellow Flags
Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 26 and 52 weeks.
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The Optimal Screening for Prediction of Referral and Outcome (OSPRO) is designed to assess pain-associated psychological distress.
The OSPRO-YF includes items from pain vulnerability domains (negative affect and fear-avoidance) and pain resilience domains (positive affect and self-efficacy) to identify pain associated psychological distress.
We will use the 17-item version of the OSPRO-YF tool.
A summary score can be created by summing all item responses from the original parent questionnaires on the original scale, with pain-resilience items reverse scored, providing a potential score range of 6 to 89, with higher scores indicating higher psychological distress.
Scores for each of the 11 original parent questionnaires used to create the OSPRO-YF will also be calculated.
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Baseline, 2 weeks, 4 weeks, 8 weeks, 26 and 52 weeks.
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Collaborators and Investigators
Investigators
- Principal Investigator: Lori A Michener, PT, ATC, PhD, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-20-00994
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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