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

Not Applicable

Completed

• Conditions: Transcutaneous; Pulsed Radiofrequency; Corticosteroids Injections; Pain; Lateral Epicondylitis
• Interventions: Device: Transcutaneous pulsed radiofrequency; Drug: Methylprednisolone and mepacaine

• Registration Number: NCT06710704
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-10-24
• Study Completion: 2024-10-24
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-29
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcutaneous pulsed radiofrequency group	Transcutaneous pulsed radiofrequency	Patients underwent transcutaneous pulsed radiofrequency at the affected elbow.
Control group	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.

Primary Outcome Measures

Name	Time	Method
Degree of pain.	12 weeks after treatment	Assessment of pain severity by visual analog scale (VAS) before treatment and at 2, 4, 8, and 12 weeks after treatment.; The visual analog scale (VAS) score it has 10-cm scale that represents a continuum between "0 = no pain" and "10 = worst pain."

Secondary Outcome Measures

Name	Time	Method
Forearm pain	12 weeks after treatment	Forearm pain wasassessed by patient-rated tennis elbow evaluation (PRTEE).; The Rated Tennis Elbow Evaluation (PRTEE) was also used to rate the levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: Pain subscale - 5 items (0 = no pain, 10 = worst imaginable). Function subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items.
Functional disability	12 weeks after treatment	Functional disability was assessed by patient-rated tennis elbow evaluation (PRTEE) before treatment and at 2, 4, 8, and 12 weeks after treatment..; The Rated Tennis Elbow Evaluation (PRTEE) was also used to rate the levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: Pain subscale - 5 items (0 = no pain, 10 = worst imaginable). Function subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items.
Patient capability	12 weeks after treatment	Patient capability to operate daily activities was evaluated using Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire before treatment and at 2, 4, 8, and 12 weeks after treatment.; The Quick DASH is a shortened edition of the original DASH result amount. Quick DASH was used to measure of self-rated upper-extremity disability and symptoms before. It is a 11-item and self-report questionnaire that looks at the ability of a patient to perform certain upper extremity activities, patients can rate difficulty and interference with daily life on a 5-point Likert scale (1 being no difficulty, 5 being unable).

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, ElGharbia, Egypt