Rotator Cuff TendinosisNCT04923477
Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms
A study testing Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome in people with Rotator Cuff Tendinosis and Rotator Cuff Tendinitis, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Rotator Cuff Tendinosis, Rotator Cuff Tendinitis, Rotator Cuff Injuries
- What is being tested?
- Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory
Los Angeles, California, 90089
Kayla Seymore, PhD, 323-224-5032, kseymore@usc.edu
Lori A Michener, PhD
About this study
Official title: Mechanisms of Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome
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.
Read the detailed description
Theoretical models propose the development of shoulder pain from an acute injury or repetitive motion seen in sports and certain work environments. Repetitive motions, in combination with altered muscle activity and altered movement strategies, may lead to damage of the rotator cuff structures resulting in local shoulder pain. Emerging evidence supports the hypothesis that localized pain may result in chronic centralized pain over time through central sensitization. Central nervous system changes, specifically those at the level of the brain have been shown to play a role in chronic pain. Neurophysiological mechanisms have been shown to predict symptom progression in other chronic pain conditions. Despite a large body of evidence that therapeutic exercise, mechanisms leading to pain relief are still not well understood. Studies identify a critical role of exercise in modulating excitation and inhibition of key pain centers in the central nervous systems. However, limited evidence exists as to the mechanisms of exercise in the management of patients with chronic pain with therapeutic exercise.
- Conditions
- Rotator Cuff Tendinosis, Rotator Cuff Tendinitis, Rotator Cuff Injuries, Subacromial Pain Syndrome
- Being tested
- Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain SyndromeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Therapeutic exercise of resistance and mobility training delivered by a trained health professional x 8 weeks. Receives: Other: Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 26 weeks and 52 weeks
Secondary outcomes (4)
Functional Magnetic Resonance Imaging (fMRI)
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.
Measured: Baseline, 2 weeks, 4 weeks, and 8 weeks
Shoulder Kinematics and Muscle Activity
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.
Measured: Baseline, 2 weeks, 4 weeks, and 8 weeks
Pain pressure threshold (PPT)
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
Measured: Baseline, 2 weeks, 4 weeks, and 8 weeks
OSPRO- Yellow Flags
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.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, 26 and 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start8 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinosisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Michener, University of Southern California
- Investigators
- Lori A Michener, PT, ATC, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923477
- Sponsor's protocol ID
- HS-20-00994
- Status last verified
- Jan 2026
- First submitted
- 6 Jun 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome
- ClinicalTrials.gov ID
- NCT04923477
- Acronym / sponsor ID
- HS-20-00994
- Conditions
- Rotator Cuff Tendinosis, Rotator Cuff Tendinitis, Rotator Cuff Injuries, Subacromial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Theoretical models propose the development of shoulder pain from an acute injury or repetitive motion seen in sports and certain work environments. Repetitive motions, in combination with altered muscle activity and altered movement strategies, may lead to damage of the rotator cuff structures resulting in local shoulder pain. Emerging evidence supports the hypothesis that localized pain may result in chronic centralized pain over time through central sensitization. Central nervous system changes, specifically those at the level of the brain have been shown to play a role in chronic pain. Neurophysiological mechanisms have been shown to predict symptom progression in other chronic pain conditions. Despite a large body of evidence that therapeutic exercise, mechanisms leading to pain relief are still not well understood. Studies identify a critical role of exercise in modulating excitation and inhibition of key pain centers in the central nervous systems. However, limited evidence exists as to the mechanisms of exercise in the management of patients with chronic pain with therapeutic exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain SyndromeTherapeutic exercise of resistance and mobility training delivered by a trained health professional x 8 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain SyndromeTherapeutic 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. | Other | Exercise Group |
Primary outcome
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).
4 secondary outcomes
Functional Magnetic Resonance Imaging (fMRI)
Time frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
Shoulder Kinematics and Muscle Activity
Time frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
Pain pressure threshold (PPT)
Time frame: Baseline, 2 weeks, 4 weeks, and 8 weeks
OSPRO- Yellow Flags
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 26 and 52 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lori A Michener, PT, ATC, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome in people with Rotator Cuff Tendinosis and Rotator Cuff Tendinitis, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori A Michener, PT, ATC, PhD (323-224-5032, lmichene@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pennsylvania Shoulder Score (PENN) (time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 26 weeks and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.