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

NCT06710704 | Completed

• 1 other identifier: 36264MS267/7/23
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Degree of pain.

  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 Outcomes (3)

• Forearm pain

  12 weeks after treatment

• Functional disability

  12 weeks after treatment

• Patient capability

  12 weeks after treatment

Study Arms (2)

Transcutaneous pulsed radiofrequency group

EXPERIMENTAL

Patients underwent transcutaneous pulsed radiofrequency at the affected elbow.

Device: Transcutaneous pulsed radiofrequency

Control group

ACTIVE COMPARATOR

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

Interventions

Transcutaneous pulsed radiofrequency DEVICE

Patients underwent transcutaneous PRF at the affected elbow.

Transcutaneous pulsed radiofrequency group

Methylprednisolone and mepacaine 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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Palpation of the lateral epicondyle.
• Resisted wrist extension (Thompson test).
• Chair test. With the shoulder flexed to 60° and the elbow extended, the patient attempts to lift a chair weighing 3.5 kg.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, ElGharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Pain; Tennis Elbow

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology,Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: April 1, 2024
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data was available upon a reasonable request from the corresponding author.

Locations

EG (1)