Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease
- Conditions
- Rotator Cuff TearLateral EpicondylitisAchilles Tendinitis
- Interventions
- Biological: Ultrasound-guided pure platelet-rich-plasma (P-PRP) injectionBiological: Ultrasound-guided platelet-rich-plasma (PRP) injection
- Registration Number
- NCT03300531
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
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.
- Detailed Description
All injection will be done under ultrasound guidance.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 540
- clinically diagnosed as rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis;
- symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;
- patient that can understand the clinical trials and signed the informed consent.
- patient that underwent other injection treatment within 6 weeks
- some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
- patient that enrolled other clinical trials within 3 months
- history of drug/alcohol addiction, habitual smoker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P-PRP Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection Blood will be drawn and pure platelet-rich plasma will be injected into the tendon. PRP Ultrasound-guided platelet-rich-plasma (PRP) injection Blood will be drawn and platelet-rich plasma will be injected into the tendon. Compound betamethasone Ultrasound-guided Compound betamethasone injection 1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) )
- Primary Outcome Measures
Name Time Method Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks Baseline, 3 weeks, 6 weeks, 12 weeks after intervention Pain on activity will be evaluated by VAS
- Secondary Outcome Measures
Name Time Method Constant-Murley Score(CMS) Baseline, 3 weeks, 6 weeks, 12 weeks after intervention Functional score of the shoulder
American Shoulder and Elbow Surgeons (ASES) Shoulder Score Baseline, 3 weeks, 6 weeks, 12 weeks after intervention Functional score of the shoulder
The Disabilities of the Arm, Shoulder and Hand(DASH) Score Baseline, 3 weeks, 6 weeks, 12 weeks after intervention Functional score of the shoulder
Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A) Baseline, 3 weeks, 6 weeks, 12 weeks after intervention Functional score of the achilles tendon
Adverse events From baseline through study completion, an average of 3 year Adverse events to evaluate the safety