Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial

NCT04875338 | Completed Phase 3 DMC

• 1 other identifier: KAD-FR-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Epicondylitis, Lateral

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• evaluation common extensor morphology and vascularity with ultrasound

  baseline and 3 months after enjection

Study Arms (3)

saline injection

ACTIVE COMPARATOR

2ml %0.9 NACI(Saline )injection to effected lateral epicondyle

Drug: plate-rich plasma

platet riched plasma injection

ACTIVE COMPARATOR

2 ml prp )injection to effected lateral epicondyle

Drug: saline (0.9 NACI)

betametazon injection

ACTIVE COMPARATOR

2 ml betametazon )injection to effected lateral epicondyle

Drug: betametazon

Interventions

plate-rich plasma DRUG

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 injection

saline (0.9 NACI) DRUG

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

platet riched plasma injection

betametazon DRUG

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

betametazon injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Fatih, Turkey (Türkiye)

Location

Related 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.

  PMID: 23001116 BACKGROUND

• 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.

  PMID: 21705157 RESULT

Related Links

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

MeSH Terms

Conditions

Tennis Elbow

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asistant doctor

Model Details: propective randomize

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 6, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)