Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial

Epicondylitis, Lateral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875338
• Other study ID #: KAD-FR-02
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2023
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Epicondylitis, Lateral
• Tennis Elbow

Intervention

Drug:
• plate-rich plasma
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
• saline (0.9 NACI)
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
• betametazon
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

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHANGE IN VAS: Visual Analog Skala	we ask questions for vas score it 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
Primary	CHANGE IN 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
Primary	CHANGE IN 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	evaluation common extensor morphology and vascularity with ultrasound	it 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	baseline and 3 months after enjection

External Links

•   https://www.sciencedirect.com/science/article/abs/pii/S0363502311006289