Transcutaneous Pulsed Radiofrequency and Corticosteroids Injections in Management of Pain in Lateral Epicondylitis

NCT ID: NCT06710704

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-10-24

Brief Summary

The aim of the study is to compare between transcutaneous pulsed radiofrequency and corticosteroids injections in management of pain severity, forearm pain, functional disability and patient capability to operate daily activities in patients with lateral epicondylitis

Detailed Description

Lateral epicondylitis (LE), or tennis elbow, is the most common elbow pain condition. Pain in the lateral aspect of the elbow, especially the extensor tendon origin (extensor carpi radialis brevis [ECRB] and extensor digitorum communis [EDC]), is the most consistent symptom. It affects up to 3 % of the population and is usually an overload injury that often follows minor and often unrecognized trauma to the extensor forearm muscles of the forearm.

Transcutaneous pulsed radiofrequency treatment is a noninvasive, needleless, painless, office/outpatient treatment that requires no recovery, sedation, or anesthesia. We were encouraged to research transcutaneous pulsed radiofrequency as a treatment option because of favorable outcomes in previous trials. Therefore, transcutaneous pulsed radiofrequency treatment used successfully in a type of orthopedic surgeries, we designed this trial to examine it in the management of pain in lateral epicondylitis.

Conditions

Transcutaneous; Pulsed Radiofrequency; Corticosteroids Injections; Pain; Lateral Epicondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcutaneous pulsed radiofrequency group

Patients underwent transcutaneous pulsed radiofrequency at the affected elbow.

Group Type: EXPERIMENTAL

Transcutaneous pulsed radiofrequency

Intervention Type: DEVICE

Patients underwent transcutaneous PRF at the affected elbow.

Control group

Patients received intraarticular injections of methylprednisolone (40 mg/ml) with 1 ml mepacaine at the point with utmost tenderness in the lateral epicondyle area under aseptic conditions.

Group Type: ACTIVE_COMPARATOR

Methylprednisolone and mepacaine

Intervention Type: DRUG

Patients received intraarticular injections of methylprednisolone (40 mg/ml) with 1 ml mepacaine at the point with utmost tenderness in the lateral epicondyle area under aseptic conditions.

Interventions

Transcutaneous pulsed radiofrequency

Patients underwent transcutaneous PRF at the affected elbow.

Intervention Type: DEVICE

Methylprednisolone and mepacaine

Patients received intraarticular injections of methylprednisolone (40 mg/ml) with 1 ml mepacaine at the point with utmost tenderness in the lateral epicondyle area under aseptic conditions.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age from 18-65 years.
• Both sexes.
• Symptomatic lateral epicondylitis for more than 6 months.

Lateral epicondylitis was diagnosed when pain is elicited by two or more of these diagnostic exams:

1. Palpation of the lateral epicondyle.

2. Resisted wrist extension (Thompson test).

3. Chair test. With the shoulder flexed to 60° and the elbow extended, the patient attempts to lift a chair weighing 3.5 kg.

Exclusion Criteria

• Severe systemic diseases (diabetes or rheumatoid arthritis).
• Cervical radiculopathy.
• Major trauma or prior surgery in the tendon of the elbow.
• Morbid obese patients (body mass index (BMI) of >35 kg/m2).
• Infection at site of injection.
• Bleeding diathesis and coagulopathy.
• Patients who didn't consent to completing visual analog scale , rated tennis elbow evaluation (PRTEE), disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire. and refuse to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Magdy Ahmed Elgazzar

Resident of Anesthesiology,Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, ElGharbia, Egypt

Countries

Egypt

Other Identifiers

36264MS267/7/23

Identifier Type: -

Identifier Source: org_study_id