Tenniselbow, also known as lateral epicondylitis.
Conditions
Interventions
Product Name: platelet rich plasma
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Sponsors
Biomet NL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Men and women with lateral epicondylitis > 3 months b. Baseline elbow painscore > 5/10, > 100/200 during resisted wrist extension c. Informed consent d. Pain by palpation of the lateral epicondyle e. Pain that is unresponsive to physical therapy or a brace. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. < 18 years of age b. History of any blood disorder c. History of bleeding disorder d. History of carpal tunnel syndrome e. Cervical radiculopathy f. Systemic disorders such as diabetes, rheumatoid arthritis, and hepatitis g. Un-cooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations h. Previous surgery or corticosteroidinjections for lateral epicondylitis i. Active bilateral elbow tendinosis j. Hypothyroidism k. Hemoglobin above or below the following range 14.0-17.7 g/dl l. Hematocrit: outside of the following range: 40.0-52.0% m. Platelet counts outside of the following range: 150-400 x103/dl n. Arthrosis or fracture of the elbow, as confirmed by X-ray diagnosis (AP, lateral views) o. Do not speak Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to prove that a single injection of PRP in the COE decreases the pain and duration of the condition in patients with chronic lateral epicondylitis compared to injection with lidocaine and corticosteroids. The specific objective is to give patients with chronic lateral epicondylitis an alternative before opting for surgical treatment. ;Secondary Objective: -;Primary end point(s): To prove that a single injection of PRP in the COE decreases the pain and duration of the condition in patients with chronic lateral epicondylitis compared to injection with lidocaine and corticosteroids. | — |
Countries
Netherlands
Outcome results
None listed