Clinical trial NCT04875338: Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial
Official title: Platelet-rich Plasma, Glucocorticoid, Saline Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epicondylitis, Lateral
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: propective randomize
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effectiveness of injection techniques in the treatment of elbow lateral epicondylitis. The functional and pain levels of the patients will be evaluated with scores such as DASH, VAS, PRTEE. At the same time, USG imaging will be evaluated before injection and in the third month after injection. The study was planned as a randomized controlled prospective study.

Detailed description: Patients diagnosed with epicondylitis in our outpatient clinic will be divided into 3 groups, and patients who will receive saline in 1 group and betamethasone sodium in a group will be selected in accordance with the specified conditions and their treatment will be started, and the treatment will be started, which patient will receive which treatment will be determined by the computerized randomization program. ), 1ml prp (plate-rich plasma to be prepared with the blood taken from the patient on the day of injection), 1 ml saline (0.9 NACI), while the patient is in the supine position, the affected elbow is 90 flexion and neutral rotation, The non-dominant thumb will be placed at the sensitive point in the lateral epicondyle. The injection will be applied to the point with a 23 g needle. After the injection, the subjects will be taught a stretching exercise of the joint extensors of the wrist and fingers. Subjects will be asked to do this exercise five times in one session, two sessions a day.Examination and functional scores to be applied to the patients during follow-up: VAS, DASH and PRTEE scores will be checked in the 1st 6th week, 3rd month, 6th month and 12th month VAS: Visual Analog Scale DASH: The Disabilities of the Arm, Shoulder and Hand PRTEE: The Patient-Rated Tennis Elbow Evaluation 2. It will be evaluated by USG in the 3rd month.

Eligibility criteria: Inclusion Criteria:

1. Patients over the age of 18
2. Clinical diagnosis-
3. Symptoms lasting more than 3 months and no injection within this period
4. Radiologically diagnosed -

Exclusion Criteria:

- 1. symptoms for less than 3 months 2. Having been given injection treatment within 3 months

3. Surgical procedure for lateral epicondylitis 4. Having pain caused by the cervical spine 5. Restricted elbow range of motion 6.Having an elbow bony deformity

Primary outcomes:
measure: CHANGE İN VAS: Visual Analog Skala
timeFrame: baseline and 6th week, 3rd month, 6th month and 12th month
measure: CHANGE İN DASH: The Disabilities of the Arm, Shoulder and Hand
timeFrame: baseline and 6th week, 3rd month, 6th month and 12th month
measure: CHANGE İN PRTEE: The Patient-Rated Tennis Elbow Evaluation
timeFrame: baseline and 6th week, 3rd month, 6th month and 12th month
Secondary outcomes:
measure: evaluation common extensor morphology and vascularity with ultrasound
timeFrame: baseline and 3 months after enjection
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
state: Fatih
Study officials:
References:
citation: Chaudhury S, de La Lama M, Adler RS, Gulotta LV, Skonieczki B, Chang A, Moley P, Cordasco F, Hannafin J, Fealy S. Platelet-rich plasma for the treatment of lateral epicondylitis: sonographic assessment of tendon morphology and vascularity (pilot study). Skeletal Radiol. 2013 Jan;42(1):91-7. doi: 10.1007/s00256-012-1518-y. Epub 2012 Sep 22.
citation: Wolf JM, Ozer K, Scott F, Gordon MJ, Williams AE. Comparison of autologous blood, corticosteroid, and saline injection in the treatment of lateral epicondylitis: a prospective, randomized, controlled multicenter study. J Hand Surg Am. 2011 Aug;36(8):1269-72. doi: 10.1016/j.jhsa.2011.05.014. Epub 2011 Jun 25.