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| Name | Class |
|---|---|
| Zhejiang Xingyue Biotechnology Co., Ltd. | INDUSTRY |
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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.
All injection will be done under ultrasound guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-PRP | Experimental | Blood will be drawn and pure platelet-rich plasma will be injected into the tendon. |
|
| PRP | Experimental | Blood will be drawn and platelet-rich plasma will be injected into the tendon. |
|
| Compound betamethasone | Active Comparator | 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) ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection | Biological | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiliang Shen, Doctor | Contact | +86-13757101563 | wlshen@zju.edu.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34590307 | Derived | Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2. |
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| Ultrasound-guided platelet-rich-plasma (PRP) injection | Biological | 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. |
|
| Ultrasound-guided Compound betamethasone injection | Drug | Tendon will be penetrated with dry needle under ultrasound guidance. Compound betamethasone will be injected into the tendon.Once a week for three times. |
|
| 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 |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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