Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease

Study Overview
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Brief Summary
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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
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All injection will be done under ultrasound guidance.

Official Title
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Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease：A Randomized Controlled Trial

Conditions
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Rotator Cuff Tear, Lateral Epicondylitis, Achilles Tendinitis

Intervention / Treatment
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* Biological: Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection
* Biological: Ultrasound-guided platelet-rich-plasma (PRP) injection
* Drug: Ultrasound-guided Compound betamethasone injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P-PRP<br>Blood will be drawn and pure platelet-rich plasma will be injected into the tendon. | Biological: Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection<br>* 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.<br>|
| Experimental: PRP<br>Blood will be drawn and platelet-rich plasma will be injected into the tendon. | Biological: Ultrasound-guided platelet-rich-plasma (PRP) injection<br>* 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.<br>|
| Active Comparator: Compound betamethasone<br>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) ) | Drug: Ultrasound-guided Compound betamethasone injection<br>* Tendon will be penetrated with dry needle under ultrasound guidance. Compound betamethasone will be injected into the tendon.Once a week for three times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Visual Analog Scale(VAS) at 3, 6 and 12 weeks | Pain on activity will be evaluated by VAS | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley Score(CMS) | Functional score of the shoulder | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | 
| American Shoulder and Elbow Surgeons (ASES) Shoulder Score | Functional score of the shoulder | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | 
| The Disabilities of the Arm, Shoulder and Hand(DASH) Score | Functional score of the shoulder | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | 
| Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A) | Functional score of the achilles tendon | Baseline, 3 weeks, 6 weeks, 12 weeks after intervention | 
| Adverse events | Adverse events to evaluate the safety | From baseline through study completion, an average of 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pure Platelet-rich Plasma, Randomized Controlled Trial