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

November 26, 2024 updated by: Ahmed Magdy Ahmed Elgazzar, Tanta University

A Comparative Study Between Transcutaneous Pulsed Radiofrequency and Corticosteroids Injections in Management of Pain in Lateral Epicondylitis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • ElGharbia
      • Tanta, ElGharbia, Egypt, 31527
        • Tanta university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous pulsed radiofrequency group
Patients underwent transcutaneous pulsed radiofrequency at the affected elbow.
Device: Transcutaneous pulsed radiofrequency
Patients underwent transcutaneous PRF at the affected elbow.
Active Comparator: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of pain.
Time Frame: 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."
12 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forearm pain
Time Frame: 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.
12 weeks after treatment
Functional disability
Time Frame: 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.
12 weeks after treatment
Patient capability
Time Frame: 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).
12 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

October 24, 2024

Study Completion (Actual)

October 24, 2024

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264MS267/7/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data was available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data was available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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