Rotator Cuff Tear, Lateral Epicondylitis, Achilles Tendinitis
Conditions
Keywords
Pure Platelet-rich Plasma, Randomized Controlled Trial
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.
Interventions
BIOLOGICALUltrasound-guided pure platelet-rich-plasma (P-PRP) injection
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.
DRUGUltrasound-guided Compound betamethasone injection
Tendon will be penetrated with dry needle under ultrasound guidance. Compound betamethasone will be injected into the tendon.Once a week for three times.
Sponsors
Zhejiang Xingyue Biotechnology Co., Ltd.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. clinically diagnosed as rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis; 2. symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid; 3. patient that can understand the clinical trials and signed the informed consent.
Exclusion criteria
1. patient that underwent other injection treatment within 6 weeks 2. 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) 3. patient that enrolled other clinical trials within 3 months 4. history of drug/alcohol addiction, habitual smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactWeiliang Shen, Doctor
Outcome results
None listed