Effectiveness of standardized ultrasound guided percutaneous treatment of lateral epicondylitis with application of autologous blood, dextrose or perforation only on pain: a study protocol for a multi-center, blinded, randomized controlled trial with a 1 year follow up

BACKGROUND: In the treatment of Lateral Epicondylitis (LE) no single intervention concerning injection therapies has been proven to be the most effective with regard to pain reduction. In this trial 3 injection therapies (perforation with application of autologous blood, perforation with application of dextrose and perforation only) will be compared in a standardized and ultrasound guided way. The objective is to assess the effectiveness of these 3 injection therapies on pain, quality of life and functional recovery. By conducting this study, we hope to make a statement on the effectiveness of injection therapy in the treatment of LE. Hereby, unnecessary treatments can be avoided, a more universal method of treatment can be established and the quality of the treatment can be improved. METHODS/DESIGN: A multicenter, randomized controlled trial with a superiority design and 12 months follow-up will be conducted in four Dutch hospitals. One hundred sixty five patients will be recruited in the age of 18 to 65 years, with chronic symptomatic lateral epicondylitis lasting longer than 6 weeks, which have concordant pain during physical examination. Patients will be randomized by block randomization to one of the three treatment arms. The treatment will be blinded for patients and outcome assessors. The following three injection therapies are compared: perforation with application of autologous blood, perforation with application of dextrose and perforation only. Injections will be performed ultrasound guided in a standardized and automated way. The primary endpoint is: pain (change in ‘Visual Analogue Scale’). Secondary endpoints are quality of life and functional recovery. These measurements are collected at baseline, 8 weeks, 5 months and 1 year after treatment. DISCUSSION: When completed, this trial will provide evidence on the effectiveness of injection therapy in the treatment of lateral epicondylitis on pain, quality of life and functional recovery. In current literature proper comparison of the effectiveness of injectables for LE is questionable, due to the lack of standardization of the treatment. This study will overcome bias due to manually performed injection therapy. TRIAL REGISTRATION: This study is registered in the Trial Register (www.trialregister.nl) of the Dutch Cochrane centre. Trial ID; NTR4569. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4569