This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis. Patients will be randomly divided into three groups. Autologous pure platlet-rich plasma (P-PRP) and platlet-rich plasma (PRP) are purified from the peripheral blood .Patients of case groups will receive P-PRP or PRP injection once a week for three times while the control group received the same dose compound betamethasone injection. Follow up visit will occur at 1 month,3 months, 6 months,12 months after the last injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.
All injection will be done under ultrasound guidance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
540
Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Pure platelet-rich plasma will be injected into the tendon.Once a week for three times.
Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Platelet-rich plasma will be injected into the tendon.Once a week for three times.
Tendon will be penetrated with dry needle under ultrasound guidance. Compound betamethasone will be injected into the tendon.Once a week for three times.
Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks
Pain on activity will be evaluated by VAS
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Constant-Murley Score(CMS)
Functional score of the shoulder
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Functional score of the shoulder
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
The Disabilities of the Arm, Shoulder and Hand(DASH) Score
Functional score of the shoulder
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A)
Functional score of the achilles tendon
Time frame: Baseline, 3 weeks, 6 weeks, 12 weeks after intervention
Adverse events
Adverse events to evaluate the safety
Time frame: From baseline through study completion, an average of 3 year
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