Tennis elbow, also known as lateral epicondylitis MedDRA version: 9.1 Level: LLT Classification code 10014971 Term: Epicondylitis
Conditions
Interventions
Product Name: corticosteroid
Product Code: Depo-Medrol met Lidocaïne
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: METHYLPREDNISOLONE ACETATE
CAS Number: 53361
Other descriptive n
Sponsors
Biomet Nederland BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Man and woman with lateral epicondylitis >3 months Baseline elbow painscore >5/10, >100/200 during resisted wrist extension informed consent pain by palpation of the lateral epicondyle 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: <18 years history of any blood disorder history of bleeding disorder history of carpal tunnel syndrome cervical radicupathy system disorders such as diabetis, rheumatoid arthritis and hepatitis uncooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow up examinations previous surgery or corticosteroidinjections for lateral epicondylitis active bilateral elbow tendinosis hypothyroidism hemoglobin above or below the following range 14,0-17,7 g/dl hemocrit outside the following range 40,0-52,0% platelet counts outside the following range150-400x103/dl arthrosis or fracture of the elbow as confirmed by X ray diagnosis 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 cchronic 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): Pain function Percentage of patients with >25% pain reduction | — |
Countries
Netherlands
Outcome results
None listed