CLINICAL TRIAL

Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome for Rotator Cuff Tears

Recruiting · 18 - 65 · All Sexes · Los Angeles, CA

This study is evaluating whether exercise can help people with rotator cuff tendinopathy.

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About the trial for Rotator Cuff Tears

Eligible Conditions
Rotator Cuff Injuries · Rotator Cuff Tendinitis · Syndrome · Tendinopathy · Rotator Cuff Tendinosis · Somatoform Disorders · Subacromial Pain Syndrome

Treatment Groups

This trial involves 2 different treatments. Therapeutic Exercise For Rotator Cuff Tendinopathy / Subacromial Pain Syndrome is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participant BMI ≤ 30
pain ≥ 3/10 on a numeric pain rating scale
age: 18 - 45 years
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Visit 1, 2, 3 (baseline, 2 weeks, 4 weeks)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Visit 1, 2, 3 (baseline, 2 weeks, 4 weeks).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome will improve 1 primary outcome and 3 secondary outcomes in patients with Rotator Cuff Tears. Measurement will happen over the course of Visit 1 and 2 (baseline, 2 weeks).

Pain pressure threshold (PPT)
VISIT 1 AND 2 (BASELINE, 2 WEEKS)
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
Shoulder Kinematics and Muscle Activity
VISIT 1 AND 2 (BASELINE, 2 WEEKS)
Shoulder kinematics of the humerus, thorax, and scapula will be assessed. Muscle activity will be assessed of the infraspinatus muscle of the rotator cuff, deltoid, upper, lower, and middle trapezius, and serratus anterior muscles.
Functional MRI (fMRI)
VISIT 1 AND 2 (BASELINE, 2 WEEKS)
A high resolution structural image will be acquired from each participant with a magnetization-prepared rapid gradient-echo (MP-RAGE) sequence, with 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
Pennsylvania Shoulder Score (PENN)
VISIT 1, 2, 3 (BASELINE, 2 WEEKS, 4 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).

Who is running the study

Principal Investigator
L. M.
Lori Michener, Principal Investigator
University of Southern California

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the latest research for rotator cuff tears?

Evidence-based practice is limited by the low quality of research found in the literature and the poor evidence level of the reviewed studies. More high-quality research is needed.

Anonymous Patient Answer

Can rotator cuff tears be cured?

At least some patients with small rotator cuff tears have the ability to recover normal shoulder function, and for these patients, long-term results in the shoulder range of motion are satisfactory after a single treatment in most cases.

Anonymous Patient Answer

What are the signs of rotator cuff tears?

Tear characteristics such as location, size, and severity are important. A tear will often result in increased shoulder pain, decreased shoulder motion, and pain with lifting/carrying. Decreased shoulder function results in the inability to meet work or sporting requirements. Subjective data are paramount as it is the only measure that can distinguish between a traumatic rotator cuff tear and a degenerative tear. Magnetic resonance imaging (MRI) is the gold standard method for diagnosis and follow-up of rotator cuff tears.

Anonymous Patient Answer

What are common treatments for rotator cuff tears?

Approximately one-third of patients with rotator cuff tears undergo surgery. Most rotator cuff repairs are performed using sutures; other techniques include arthroscopy and anchor repair. Complications of rotator cuff repair include deltoid muscle injury and revision procedures.

Anonymous Patient Answer

What is rotator cuff tears?

Symptoms were common. Symptoms included shoulder pain, fatigue, weakness, or stiffness and were worse when the shoulder was in abduction. Pain was seen in more than half of patients. The shoulder mobility, arm function and shoulder strength were unaffected. The patient was able to return to daily activities, work and sport. There was no correlation between the symptoms and the range of motion, muscle strength, activity level, or the ability to participate in sports activities. In the study, only a minority had physical examination findings suggestive of a tear. Results from a recent clinical trial of an MRI of the shoulder indicate that the labrum most often remains intact. [BMI (body mass index)] has been found to be an independent risk factor for tearing the rotator cuff [M.

Anonymous Patient Answer

How many people get rotator cuff tears a year in the United States?

In a recent study, findings shows significant over- and under-reporting of rotator cuff tear rates. When we correct for these under- and over-reporting rates there appears to be no significant trend in rotator cuff tear severity rates or rates of surgical repair.

Anonymous Patient Answer

What causes rotator cuff tears?

Traumatic tearing of the rotator cuff is a major risk factor for subsequent tears in individuals without a family history of the disorder, as well as in people with a family history of the disorder. A history of shoulder dysfunction in the first degree relative may be an independent risk factor. This data may provide insight into the prevention of rotator cuff tears or tear progression.

Anonymous Patient Answer

What is the average age someone gets rotator cuff tears?

Since this is the first study to analyze the association of self-reported symptoms of rotator cuff tears and radiographic findings, we conclude that in middle-aged patients without prior rotator cuff tears, the presence of rotator cuff tears has little effect on functional outcomes.

Anonymous Patient Answer

Has therapeutic exercise for rotator cuff tendinopathy / subacromial pain syndrome proven to be more effective than a placebo?

A non-statistic analysis of a large dataset was used to assess the efficacy of therapeutic exercise for treatment of painful rotator cuff tendinopathy / subacromial pain syndrome. Although data were not significant and data from previous studies were omitted from this analysis, there are strong indications that exercise may assist in the healing process and reduce pain. It will be interesting to see results of an ongoing randomised design. Data from a recent study are not statistically significance enough to be a reason enough to recommend therapeutic exercise. The evidence level used here is low. This is not a recommendation for treatment, but rather a suggestion of things to do more high quality research on.

Anonymous Patient Answer

Have there been any new discoveries for treating rotator cuff tears?

To date, some of the existing treatment modalities for rotator cuff tendinosis seem to prove useful in minimizing the healing time and reducing the risk of rotator cuff tears. A meta-analysis conducted on randomized studies showed no significant difference between suture-reinforced and nonreinforced arthroscopic treatment for rotator cuff tendinosis, other than the suture-reinforced technique significantly reducing pain in the short-term compared to the nonreinforced technique. However, in the long-term randomized studies showed no difference in either pain, pain resolution or reoperation. Additional randomized clinical studies with longer follow-up is needed to make a conclusion.

Anonymous Patient Answer

Does therapeutic exercise for rotator cuff tendinopathy / subacromial pain syndrome improve quality of life for those with rotator cuff tears?

Recent findings of this study suggest that exercise can significantly improve health-related quality of life for those with rotator cuff tendinopathy/subacromial pain syndrome regardless of severity of disease.

Anonymous Patient Answer

What is the primary cause of rotator cuff tears?

About half of rotator cuff tears are due to a previous episode of blunt force trauma. For older patients, it is most likely that a shoulder subluxation or dislocation is the cause of the tear. More commonly, rotator cuff tears are due to strenuous labour-related movements of the arm with a repetitive tear. For patients older than 65 years, pain typically begins in the upper back or shoulder area. The disorder responds well to conservative medical treatment.

Anonymous Patient Answer
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