Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial

Phase 3

Completed

• Conditions: Epicondylitis, Lateral
• Interventions: Drug: plate-rich plasma; Drug: saline (0.9 NACI); Drug: betametazon

• Registration Number: NCT04875338
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-06
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline injection	plate-rich plasma	2ml %0.9 NACI(Saline )injection to effected lateral epicondyle
platet riched plasma injection	saline (0.9 NACI)	2 ml prp )injection to effected lateral epicondyle
betametazon injection	betametazon	2 ml betametazon )injection to effected lateral epicondyle

Primary Outcome Measures

Name	Time	Method
CHANGE İN VAS: Visual Analog Skala	baseline and 6th week, 3rd month, 6th month and 12th month	we ask questions for vas score ıt has explained https://www.orthopaedicscore.com/, minum score 1 maximum 10 The higher the score, the greater the pain, and we expect it to decrease after the process.
CHANGE İN DASH: The Disabilities of the Arm, Shoulder and Hand	baseline and 6th week, 3rd month, 6th month and 12th month	we ask questions which has explained in https://www.orthopaedicscore.com/ The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)-this is called the DASH score. we expect it to decrease after the process.
CHANGE İN PRTEE: The Patient-Rated Tennis Elbow Evaluation	baseline and 6th week, 3rd month, 6th month and 12th month	The Patient-Rated Tennis Elbow Evaluation (PRTEE) is designed to evaluate pain and disability in subjects with lateral elbow tendinopathy. This questionnaire is available in Swedish, Italian, and some other languages. A Persian language version of the questionnaire is needed for both research and clinical purposes. The higher the score, the greater the pain, and we expect it to decrease after the process.

Secondary Outcome Measures

Name	Time	Method
evaluation common extensor morphology and vascularity with ultrasound	baseline and 3 months after enjection	ıt will perform by radiology doctor in istanbul university radiology department , In order to assess common extensor tendon morphology and vascularity, ana-tomic grayscale US images of the injected elbow wereperformed to establish the degree of tendinosis, using anL17-5 linear-phased transducer (Philips Medical Systems,Bothell, WA, USA) with the elbow in flexion and forearmpronated to the "thumbs up"position. Contrast harmonicimaging, using an amplitude modulation technique, wasperformed with the patient sitting and the elbow in flexionusing an L12-5 phased-array linear transducer with an IU22US scanner (Phillips Medical Systems, Bothell, WA, USA)to visualize the common extensor tendon at the lateralepicondyle

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Istanbul, Fatih, Turkey