Rotator Cuff TearsNCT06192459
Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear
A study testing Modality physical therapy and Combined therapy: in people with Rotator Cuff Tears, run by Taipei Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Modality physical therapy and Combined therapy:
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Oct 2023to 11 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, ROC, 24213
Huan-Jui Yeh, Doctor, 886＋978079519, yetil102@hotmail.com
Chun-Yuan Shih, Master, 886＋0909078939, austinhills33@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Modality physical therapy, Combined therapy:
- Keywords
- PRP, Shoulder joint mobility
- 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.
Modality physical therapyDevice
Magnetotherapy, low-energy laser, electrotherapy, etc.
Combined therapy:Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Modality physical therapy vs combined therapy | Experimental | 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. Receives: Device: Modality physical therapy; Other: Combined therapy: |
| Combined therapy vs modality physical therapy | Experimental | 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. Receives: Device: Modality physical therapy; Other: Combined therapy: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual muscle testing
Manual muscle testing with hand-held dynamometry.
Measured: pre-intervention/ three weeks after (post-first intervention)/ six weeks after (post-second intervention)
Shoulder joint range of motion test
Shoulder joint range of motion test with hand-held goniometer
Measured: pre-intervention/ three weeks after (post-first intervention)/ six weeks after (post-second intervention)
Shoulder Pain and Disability Index
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.
Measured: pre-intervention/ three weeks after (post-first intervention)/ six weeks after (post-second intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start6 Oct 2023
- Primary completion11 Jun 2024 (estimated)
- Study completion11 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192459
- Sponsor's protocol ID
- 202316
- Status last verified
- Jan 2024
- First submitted
- 6 Oct 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06192459
- Acronym / sponsor ID
- 202316
- Conditions
- Rotator Cuff Tears
- Keywords
- PRP, Shoulder joint mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 11 Jun 2024 (estimated)
- Study completion
- 11 Sep 2024 (estimated)
- First posted
- 5 Jan 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modality physical therapy vs combined therapy | Experimental | Device: Modality physical therapy, Other: 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. |
| Combined therapy vs modality physical therapy | Experimental | Device: Modality physical therapy, Other: Combined 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Modality physical therapyMagnetotherapy, low-energy laser, electrotherapy, etc. | Device | Combined therapy vs modality physical therapy, Modality physical therapy vs combined therapy |
| Combined therapy: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. | Other | Combined therapy vs modality physical therapy, Modality physical therapy vs combined therapy |
Primary outcome
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2
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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. This study is not recruiting at the moment.
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modality physical therapy and Combined therapy: in people with Rotator Cuff Tears, run by Taipei Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual muscle testing (time frame: pre-intervention/ three weeks after (post-first intervention)/ six weeks after (post-second intervention)). The study lists 3 primary outcomes in all. 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 5 Jan 2024.