- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06192459
Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear
Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear: a Randomized, Cross-over Trial
Background:
Although it is known that Platelet-Rich Plasma injections have a remarkable pain relief effect for patients with partial tears of the rotator cuff in the shoulder joint, many patients still experience limited muscle strength and joint mobility recovery. Patients often inquire about post-Platelet-Rich Plasma injection rehabilitation and precautions. Therefore, it is necessary to design a comprehensive post-injection rehabilitation and training plan to improve the quality of treatment. However, previous literature on post-Platelet-Rich Plasma injection treatment seems to have inconsistent rehabilitation plans. One major reason for this inconsistency might be the lack of sufficient evidence or unclear rehabilitation effectiveness, leading to poor patient compliance. The underlying cause of these issues is the absence of a standardized and effective rehabilitation plan. Hence, it is essential to develop a standardized rehabilitation plan to enhance treatment effectiveness.
Method:
The investigators designed a non-blinded, randomized, crossover trial to observe the potential benefits of muscle strength and joint mobility rehabilitation intervention one month after PRP injection treatment for patients with partial tears of the rotator cuff. Patients were randomly divided into two groups. One group received only standard physical therapy (magneto-therapy, low-energy laser, electrotherapy, etc.), while the other group underwent muscle strength and joint mobility training in addition to standard physical therapy. There were three assessment time points: pre-assessment (one week after Platelet-Rich Plasma injection), after the first stage of treatment (three weeks of rehabilitation training + standard physical therapy/standard physical therapy following the first Platelet-Rich Plasma injection treatment), and after the second stage of treatment (three weeks of rehabilitation training + standard physical therapy/standard physical therapy following the second Platelet-Rich Plasma injection treatment).
The assessment methods included quantifying muscle strength using a hand-held dynamometer (Manual Muscle Test) and measuring three shoulder joint angles (abduction, external rotation, internal rotation). The Shoulder Pain and Disability Index recorded changes and progress in each value at different treatment stages.
Analysis: A repeated-measures Analysis of Variance model was used to analyze the trial's effects and correlations. We also analyzed whether the dose-effect existed concerning the use of time/frequency.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ROC
-
New Taipei City, ROC, Taiwan, 24213
- Recruiting
- Taipei Hospital, Ministry of Health and Welfare
-
Contact:
- Huan-Jui Yeh, Doctor
- Phone Number: 886+978079519
- Email: yetil102@hotmail.com
-
Contact:
- Chun-Yuan Shih, Master
- Phone Number: 886+0909078939
- Email: austinhills33@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with rotator cuff tears who have undergone PRP (Platelet-Rich Plasma) treatment. All participants must sign an informed consent form.
- Patients must fully participate in the rehabilitation treatment throughout the study.
Exclusion Criteria:
- Patients with concomitant other skeletal joint issues, such as multiple joint arthritis, humeral or acromioclavicular joint fractures, or those who have undergone previous shoulder joint surgeries.
- Patients with severe shoulder joint immobility or contracture preventing any joint movement, but mild to moderate joint mobility restrictions are not considered exclusion criteria.
- Inability to comply with the two-month research project.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Modality physical therapy vs combined therapy
Participants in this are will receive one month of modality physical therapy followed by one month of modality therapy combined muscle strengthening and joint mobility training.
|
Magnetotherapy, low-energy laser, electrotherapy, etc.
Muscle strength and joint mobility training, provided twice a week for a duration of three weeks (with assessment on the second session of the third week), totaling six rehabilitation sessions.
Additionally, patients are required to engage in daily home-based rehabilitation.
During the hospital-based training sessions, a therapist provides guidance and conducts the training.
This process encompasses progressive muscle strength training, manual joint mobilization, and active and passive joint movement training to achieve effective rehabilitation outcomes.
Each rehabilitation session in the hospital lasts approximately 30 minutes.
For home-based training, patients must follow the therapist's instructions and complete 20-30 minutes of home rehabilitation every day.
Modality physical therapy are are carry out as usual.
|
Experimental: Combined therapy vs modality physical therapy
Participants in this are will receive one month of modality therapy combined muscle strengthening and joint mobility training followed by one month of modality physical therapy.
|
Magnetotherapy, low-energy laser, electrotherapy, etc.
Muscle strength and joint mobility training, provided twice a week for a duration of three weeks (with assessment on the second session of the third week), totaling six rehabilitation sessions.
Additionally, patients are required to engage in daily home-based rehabilitation.
During the hospital-based training sessions, a therapist provides guidance and conducts the training.
This process encompasses progressive muscle strength training, manual joint mobilization, and active and passive joint movement training to achieve effective rehabilitation outcomes.
Each rehabilitation session in the hospital lasts approximately 30 minutes.
For home-based training, patients must follow the therapist's instructions and complete 20-30 minutes of home rehabilitation every day.
Modality physical therapy are are carry out as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manual muscle testing
Time Frame: pre-intervention/ three weeks after (post-first intervention)/ six weeks after (post-second intervention)
|
Manual muscle testing with hand-held dynamometry.
|
pre-intervention/ three weeks after (post-first intervention)/ six weeks after (post-second intervention)
|
Shoulder joint range of motion test
Time Frame: pre-intervention/ three weeks after (post-first intervention)/ six weeks after (post-second intervention)
|
Shoulder joint range of motion test with hand-held goniometer
|
pre-intervention/ three weeks after (post-first intervention)/ six weeks after (post-second intervention)
|
Shoulder Pain and Disability Index
Time Frame: pre-intervention/ three weeks after (post-first intervention)/ six weeks after (post-second intervention)
|
self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
The pain dimension consists of five questions regarding the severity of an individual's pain.
Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
|
pre-intervention/ three weeks after (post-first intervention)/ six weeks after (post-second intervention)
|
Collaborators and Investigators
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202316
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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