Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Platelet-rich Plasma, Glucocorticoid, Saline Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial

Conditions
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Epicondylitis, Lateral

Intervention / Treatment
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* Drug: plate-rich plasma
* Drug: saline (0.9 NACI)
* Drug: betametazon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over the age of 18 Clinical diagnosis- Symptoms lasting more than 3 months and no injection within this period 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: propective randomize
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: saline injection<br>2ml %0.9 NACI(Saline )injection to effected lateral epicondyle | Drug: plate-rich plasma<br>* 1ml prp (plate-rich plasma to be prepared with the blood taken from the patient on the day of injection), , 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<br>|
| Active Comparator: platet riched plasma injection<br>2 ml prp )injection to effected lateral epicondyle | Drug: saline (0.9 NACI)<br>* 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<br>|
| Active Comparator: betametazon injection<br>2 ml betametazon )injection to effected lateral epicondyle | Drug: betametazon<br>* 1 ml betametazon 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE İN VAS: Visual Analog Skala | 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. | baseline and 6th week, 3rd month, 6th month and 12th month | 
| CHANGE İN DASH: The Disabilities of the Arm, Shoulder and Hand | 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. | baseline and 6th week, 3rd month, 6th month and 12th month | 
| CHANGE İN PRTEE: The Patient-Rated Tennis Elbow Evaluation | 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. | baseline and 6th week, 3rd month, 6th month and 12th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation common extensor morphology and vascularity with ultrasound | 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 upposition. 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 | baseline and 3 months after enjection |