Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear

NCT ID: NCT06192459

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-06
• Study Completion Date: 2024-09-11

Brief 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. 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.

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Modality physical therapy

Intervention Type: DEVICE

Magnetotherapy, low-energy laser, electrotherapy, etc.

Combined therapy:

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Modality physical therapy

Intervention Type: DEVICE

Magnetotherapy, low-energy laser, electrotherapy, etc.

Combined therapy:

Intervention Type: 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.

Interventions

Modality physical therapy

Magnetotherapy, low-energy laser, electrotherapy, etc.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with rotator cuff tears who have undergone PRP (Platelet-Rich Plasma) treatment. All participants must sign an informed consent form.

2. Patients must fully participate in the rehabilitation treatment throughout the study.

Exclusion Criteria

1. 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.

3. Inability to comply with the two-month research project.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Hospital, Ministry of Health and Welfare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Hospital, Ministry of Health and Welfare

New Taipei City, ROC, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Huan-Jui Yeh, Doctor

Role: primary

yetil102@hotmail.com

886＋978079519

Chun-Yuan Shih, Master

Role: backup

austinhills33@gmail.com

886＋0909078939

Other Identifiers

202316

Identifier Type: -

Identifier Source: org_study_id