Effect of a Platelet Rich Plasma (PRP) injection on the outcome of chronic lateral epicondylitis. A double blinded randomized controlled clinical trial.
Withdrawn
- Conditions
- Lateral epicondylitisTenniselbow100013161004323710040795
- Registration Number
- NL-OMON40290
- Lead Sponsor
- Ziekenhuisvoorzieningen Gelderse Vallei
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
- Elbow epicondylar pain increasing with pressure and with resisted wrist extension or with resisted third finger extension for more than 6 months and resistant to conservative treatment programs
- Age range 18 * 70 years
- Proved lateral epicondylitis by ultrasound
- Insufficient recovery (PRTEE-score * 40) after an integrated multidisciplinary rehabilitation program
Exclusion Criteria
- Previous local injection therapy in the past six months
- Other disease with potential influence on the tendinopathy or PRP treatment effect, such as inflammatory arthritis, autoimmune disease, CRPS or signs of posterior interosseous nerve entrapment
- NSAID use
- Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is the PRTEE-score at six months. This score is build up out<br /><br>of two parts, a section of five questions about pain and a section of ten<br /><br>questions about functional disabilities. The functional section consists of six<br /><br>questions about specific activities and four questions about usual activities.<br /><br>All questions can be rated from zero to ten. For calculating the total PRTEE<br /><br>score the total of the function section is divided by two and added to the pain<br /><br>section. The PRTEE has proven to be a reliable questionnaire and sensitive to<br /><br>change</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are the VAS score, an ultrasound at six months, DASH score<br /><br>including the work and sports/performing arts module to evaluate the quality of<br /><br>work and leisure time in relation to the complaints of the lateral<br /><br>epicondylitis. Furthermore the pain-free grip strength and maximum grip<br /><br>strength will be measured with a dynamometer. The mean value (kg) of three<br /><br>efforts will be calculated, separated by 20 seconds rest intervals. Three<br /><br>global change indices (GCI) which consist of the quality of the most commonly<br /><br>performed activity (e.g. hammering or writing), the satisfaction of the<br /><br>individual with the received treatment and the amount of compliance of the home<br /><br>based exercises. The GCI are scored using a transitional scale. Complications<br /><br>and reinterventions will be registered.</p><br>