Multiple Platelet-Rich Plasma Lateral Epidondylitis Injections Versus a Single Platelet-Rich Plasma Injection

Study Overview
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Brief Summary
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To determine the ideal dose of PRP for lateral epicondylitis. To see if 2 PRP injections are better than a single PRP injection or a saline injection to improve function and pain in patients with lateral epicondylitis.

Detailed Description
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Is there greater clinical improvement in long term pain and function when patients receive two PRP injections instead of one? This is a double-blinded randomized controlled study to determine the ideal treatment regimen for treatment of chronic lateral epicondylitis (tennis elbow). The investigators will compare pain visual analog scale (VAS) scores and functional Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire scores of patients receiving a single PRP injection and two PRP injections. The study will be conducted at Kaiser Modesto Sports Medicine involving 532 patients who meet strict criteria for chronic lateral epicondylitis (including greater than 2 months of chronic lateral epicondylitis and failing at least one other treatment modality). Patients are randomly divided between three groups: 234 patients will receive one PRP injection, 234 will receive two, and 64 in the control group will receive a saline injection. All participants will receive concurrent home based stretching and strengthening exercises. Results are to be measured using the Visual Analog Scale (VAS) and Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire on the initial and follow-up visits of 2, 6, and 12 months. Both measures have been validated by prior studies. Successful treatment of lateral epicondylitis will be defined as a 25% reduction in visual analog score VAS and DASH scores between initial and 6 month visits. Average control and experimental groups VAS scores are expected to be 8 out of 10 with an improvement to 7 and 6 respectively in 6 months. Average control and experimental group DASH scores are expected to be 49 with an improvement to 44 and 28 respectively in 6 months. PRP is an effective treatment in reducing pain of chronic lateral epicondylitis. This study aims to prove there is greater clinical improvement in long term pain and function when patients receive two PRP injections instead of one.

Official Title
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Multiple Platelet-Rich Plasma Lateral Epidondylitis Injections Versus a Single Platelet-Rich Plasma Injection in a Double-Blinded Randomized Controlled Study (PRPLE)

Conditions
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Tennis Elbow, Lateral Epicondylitis

Intervention / Treatment
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* Other: Platelet Rich Plasma Injection
* Other: Saline Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lateral epicondylitis - diagnosed by orthopedic or sports medicine physicians / 2 separate examinations (examination at referral / confirmatory examination at time of injection) Pain at the lateral epicondyle on direct palpation Pain with resistive wrist extension and/or supination No clinical findings at annular ligament, radiocapitellar joint, or PIN (posterior interosseous nerve syndrome) No underlying bone pathology Symptoms present for > 3 months Visual analog score (VAS) that is >= 5/10 Last steroid injection > 3 months Failed previous therapy (> = 4 weeks of strap, splint, cast, injection or any other accepted therapy without satisfactory pain or function) Exclusion Criteria: Age < 18 years Pregnant Symptomatic Carpal Tunnel syndrome on the affected side History of cervical radiculopathy History of Diabetes Mellitus, Rheumatoid Arthritis, hepatitis Blood disorder No immunocompromised patients (Human ImmunoDeficiency Virus, cancer, immunomodulator therapies) Oral Nonsteroidal Antiinflammatory in the past 1 week or Steroid Drug use in the past 3 months Participation in a workers' compensation program or planning to apply for the program and/or any ongoing, pending, or planned legal action as a result of elbow pain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple PRP Injection<br>2 PRP Injections 2 months apart | Other: Platelet Rich Plasma Injection<br>* Plasma component of blood rich in growth factors -during the injection, 5 needle fenestrations will be done to help stimulate blood flow to the area for healing<br>* Other names: PRP;|
| Experimental: Single PRP Injection<br>1 PRP Injection and Saline Injection 2 months apart | Other: Platelet Rich Plasma Injection<br>* Plasma component of blood rich in growth factors -during the injection, 5 needle fenestrations will be done to help stimulate blood flow to the area for healing<br>* Other names: PRP;Other: Saline Injection<br>* Saline -during the injection, 5 needle fenestrations will be done to help stimulate blood flow to the area for healing<br>* Other names: Saline;|
| Active Comparator: Saline Injection<br>2 Saline Injections 2 months apart | Other: Saline Injection<br>* Saline -during the injection, 5 needle fenestrations will be done to help stimulate blood flow to the area for healing<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | VAS Score | 6 months | 
| Function | DASH Score | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRP, Platelet Rich Plasma, Lateral Epicondylitis, Lateral Epicondylopathy, Lateral Epicondylosis, Chronic Lateral Epicondylitis, PRPLE, Multiple PRP Injections, Multiple PRP, Platelet-Rich Plasma, Tennis Elbow, Double Blinded Randomized Controlled, Multiple vs Single PRP injections, prp tennis elbow