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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 4 weeks, 8 weeks, 26 and 52 weeks.
Awards & highlights
Study 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 belowSelect...
My pain level is 3 or higher on a scale of 0 to 10.
Select...
I am between 18 and 45 years old.
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.
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,228 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.My pain level is 3 or higher on a scale of 10.I struggle to understand and fill out questionnaires.I have pain in my neck or upper back.I have had surgery on my shoulder, neck, or upper back.I cannot attend sessions in person.My pain level is 3 or higher on a scale of 0 to 10.I am between 18 and 45 years old.I have been diagnosed with narrowing of the spinal canal in my neck.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Rotator Cuff Tears Patient Testimony for trial: Trial Name: NCT04923477 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots left for participants in this research project?
"From what is indicated on clinicaltrials.gov, this clinical trial is looking for participants and is currently open. The first posting was on 6/8/2021, with the most recent update on 10/31/2022."
Answered by AI
Does this experiment allow for elderly test subjects?
"The target enrolment group for this trial are individuals who are between 18-45 years old."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Tennessee
California
What site did they apply to?
Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
hope the study will help myself and others with the same struggle.. i am tired of dealing with consistent pain and discomfort in both my shoulders.
PatientReceived 1 prior treatment
open to options that will improve my quality of life and allow me to work out without so much pain and discomfort...
PatientReceived no prior treatments
i am open to solutions which may improve my shoulder function, mobility, range of motion and improve my day to day ability to function pain free..
PatientReceived no prior treatments
i do not have medical insurance at the moment. i have had 2 surgeries since 2005 on my left shoulder and 1 on my right in 2013... i am in consistant pain and discomfort... any effort to improve my condition and possibily help others is worth the effort..
PatientReceived no prior treatments
What questions have other patients asked about this trial?
how soon can we start? how soon can we get started?
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory: < 48 hours
Average response time
- < 2 Days
Typically responds via
Email
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