Studing of the effect of platelet rich plasma versus corticosteroid injection on pain and function of patients with lateral epicondylitis

comparison of the effect of corticosteroid and platelet rich plasma injection on pain and function of patients with lateral epicondylitis

In this study, 44 patients diagnosed with lateral epicondylitis in PM&R clinic of Shahid Modarres hospital will be randomly allocated to two groups of 22 patients. Randomization will be done by the means of random number generated by computer. Injection of PRP in the intervention group or steroid in the control group will be performed. This is a phase 2-3 clinical trial in which the effect of PRP injection in treatment of lateral epicondylitis and comparison it with corticosteroid injection will be studied.

In this study ,which will be conducted in Shahid Modarres hospital inTehran, patients diagnosed with lateral epicondylitis will be randomly allocated to two groups of 22 patients based on the random numbers generated by computer, and will be injected either with steroid or PRP. unfortunately, because of blood obtaining procedure in PRP group, blinding of patients is not possible in this trial. In steroid injection group, 40mg methylprednisolone acetate and in PRP injection group 2cc of PRP, obtained from centrifuge of patients blood, will be injected in maximum point of tenderness with peppering technique. The outcome of intervention will be measured by three scales. Pain will be assessed by visual analogue scale and pressure pain threshold and function will be measured by Modified Mayo clinic performance index for elbow. These measurements will be done before injection, 2 and 6 months after injections and results will be compared among groups. The goal of this study is to evaluate pain reduction and function improvement in each group and comparison of two groups in this regard. Also, incidence of complications in each group will be studied and compared with the other group.

Patients diagnosed with lateral epicondylitis by means of physical examination who has been suffering from symptoms for more than 3 months and their pain score is more than 5 in visual analogue scale will be included in this study. The exclusion criteria are age of 70 years or more; systemic diseases; diseases in which the symptoms may overlap with patients symptoms for example radiculopathy or peripheral nerve lesions; blood cell count disorders; autoimmune diseases; malignancies or infectious diseases; using medications that interfere with platelet function or steroids; pregnancy or breast feeding.

In PRP group, first 20cc of patient's blood will be obtained and centrifuged for 15 minutes with 1600 rpm to seperate platelets from erythrocytes and then centrifuged with 2800rpm for 7 minutes to concentrate the platelets. 8 minutes after being prepped and draped and injected by 2cc of Lidocaine 1%, the point of maximum tenderness will be injected by 2cc of leukocyte rich PRP with peppering technique, via a needle of gauge 22. in corticosteroid injection group, 40mg of methylprednisolone acetate with a volume of 1 cc will be injected in maximum point of tenderness by a 22G needle with peppering technique, 8 minutes after prepping and injecting this point with 2cc of Lidocaine 1%. No kinds of steroids or NSAIDs will be prescribed during follow up period. To reduce pain, only Paracetamol will be used along with ice. Patients of both groups will be requested to refrain from heavy labor activities for a week. Tennis elbow strap will be administered for all patients and they will be instructed to apply the strap 2 centimeters below the maximal tenderness point at elbow. Therapeutic exercises will be taught by a PM&R resident and instructions will be provided in writing to help patients do the exercises correctly. 3 days after injection patients will be asked to begin stretching of extensor muscles and two weeks after injection, eccentric exercises will begin twice daily for 5 weeks and after 4 weeks, the patient can return to daily activities with no restrictions.

Outcomes will be measured by 3 means, pain will be measured subjectively by VAS score, and objectively algometer device will measure the pressure pain threshold. Function will be evaluated by means of Modified Mayo clinic performance index for elbow score.

This study is funded by the PM&R department of SBUMS.

Patients will be allocated to two groups of PRP or steroid injection according to random numbers generated by computer