Abstract
BackgroundThe study aims to identify whether Platelet-rich plasma (PRP) combined with early physiotherapy has an advantage over PRP alone for rotator cuff injury patients, regarding pain release, function score, tear size, and quality of life improvement.MethodsThis is a single-center prospective non-randomized study implemented in July 2019 at the Affiliated Hospital of Southwest Medical University in Sichuan. Three hundred-forteen patients with rotator cuff injury aged over 18 years were recruited. Participants were assigned to the experiment group (PRP plus physiotherapy) or control group (PRP) by their desire. We used the Constant-Murley score to assess the shoulder function, the Visual Analogue Scale to evaluate shoulder pain, and the MOS Item Short-form Health Survey (SF-12) to measure the quality of life. MRI was applied to measure tear size, and the follow-up duration is 12 months.DiscussionOur findings will give information on the effects of PRP and physiotherapy on rotator cuff injuries. Physiotherapy might be added to improve the effects of PRP in patients with rotator cuff injuries.Trial registrationThis study was registered in the Chinese clinical trial registry on September 1st, 2019 (ChiCTR1900025563).
Highlights
Our study aims to identify whether Platelet-rich plasma (PRP) combined with early physiotherapy has an advantage over PRP alone for rotator cuff injury patients, regarding pain release, function score, tear size, and quality of life improvement
Participants The inclusion criteria are as follows: aged over 18; shoulder pain for at least three months; Partial-thickness supraspinatus or subscapularis muscle injuries were evaluated by clinical examination, and proved by magnetic resonance imaging (MRI)
Secondary outcomes Tear size change assessed by MRI, the quality of life evaluated by Medical Outcomes Study Short Form 12
Summary
Study design A single-center, prospective non-randomized study with 12 months follow-up duration was designed. The participants need to visit a physical therapist 2 days before PRP injection, 1 months, 3 months, 6 months, and 12 months after rehabilitation programs. Participants The inclusion criteria are as follows: aged over 18; shoulder pain for at least three months; Partial-thickness supraspinatus or subscapularis muscle injuries were evaluated by clinical examination, and proved by magnetic resonance imaging (MRI). An independent radiologist will assess tear size through MRI before PRP injection and 12 months follow-up. We used a case report form (CRF) to record the information of participants, including basic information, shoulder function scores, MRI results, and follow-up. We assessed the shoulder function at four other points, two days after PRP injection, 1 month, 3 months, and 6 months. Secondary outcomes Tear size change assessed by MRI, the quality of life evaluated by Medical Outcomes Study Short Form 12-. A P value < .05 will be defined as statistically significant
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