Injectie van autologe bloedplaatjes bij epicondylitis lateralis - Platelet injection in tennis elbow

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: 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 name: depo‐medrol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 39‐41 INN or Proposed INN: LIDOCAINE HYDROCHLORIDE CAS Number: 73789 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 4.9‐5.1 CONDITION: Tennis elbow, also known as lateral epicondylitis ; MedDRA version: 9.1 Level: LLT Classification code 10014971 Term: Epicondylitis PRIMARY OUTCOME: 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 Primary end point(s): Pain; function; Percentage of patients with >25% pain reduction Secondary Objective: 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
Epistemonikos ID: 65567625eb1d31055d3c9dd16db5545eb5058c7d
First added on: Aug 21, 2024