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临床试验/NCT06192459
NCT06192459招募中不适用

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

Taipei Hospital, Ministry of Health and Welfare2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Manual muscle testing

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Manual muscle testing

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Taipei Hospital, Ministry of Health and Welfare
申办方类型
Other
责任方
Sponsor

研究点 (2)

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