Pulsed Electromagnetic Field Therapy Added to ESWT for Lateral Epicondylitis

N/ANot Yet RecruitingNCT07802938

Ali Güneri70 enrolled

Overview

This randomized, sham-controlled, assessor-blinded clinical trial will evaluate the efficacy of pulsed electromagnetic field therapy (PEMF) added to extracorporeal shock wave therapy (ESWT) in adults with lateral epicondylitis. A total of 70 participants will be randomly assigned to receive either ESWT plus active PEMF or ESWT plus sham PEMF. Both groups will also receive the same standardized home exercise program. Treatment will be administered once weekly for 5 weeks. Participants will be assessed before treatment, at the end of the 5-week treatment period, and 3 months after treatment. The primary outcome will be the Patient-Rated Tennis Elbow Evaluation (PRTEE) total score. Secondary outcomes will include pain intensity measured using the Numeric Rating Scale, pressure pain threshold, maximum and pain-free grip strength, and ultrasonographic assessment of the common extensor tendon, including tendon thickness, hypoechogenicity, and fibrillar pattern abnormalities.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lateral Epicondylitis

Interventions

Home Exercise ProgramBEHAVIORAL

All participants will receive the same standardized home exercise program. The program will include eccentric wrist extension (3 sets of 15 repetitions once daily), isometric wrist extension (3 sets of 30-second contractions once daily), and static stretching exercises targeting the forearm flexor and extensor muscle groups (3 sets of 30-second holds twice daily). The exercises will be demonstrated individually at the first session and supported with a written and visual exercise brochure. Exercise adherence will be checked and recorded weekly before each treatment session.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 and 65 years * Symptom duration of at least 3 months * Clinical diagnosis of unilateral lateral epicondylitis * Numeric Rating Scale (NRS) pain score of at least 4 * Ability and willingness to provide written informed consent Exclusion Criteria: * Injection treatment, including corticosteroid or platelet-rich plasma (PRP), within the previous 6 months * Previous application of physical therapy modalities to the affected region * Cervical radiculopathy, peripheral nerve entrapment neuropathy, or another neurological condition that may mimic lateral elbow pain * Uncontrolled diabetes mellitus, defined as HbA1c \>8%, or the presence of diabetic peripheral neuropathy * Rheumatoid arthritis or other inflammatory rheumatic diseases * Previous surgery involving the affected elbow * Elbow instability, significant limitation of joint range of motion, extensor tendon rupture, or a history of major trauma to the elbow * Other shoulder or upper extremity disorders that may explain lateral elbow pain * Active infection or open wound at the treatment site * Malignancy * Presence of a pacemaker, defibrillator, electronic implant, or other active implanted device * Pregnancy * Coagulopathy or anticoagulant use * Inability to complete the questionnaires because of cognitive impairment or expected poor adherence to follow-up

Outcomes

Primary Outcomes

Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) Total Score

The PRTEE is a lateral epicondylitis-specific questionnaire consisting of a pain subscale and a function subscale. The total score ranges from 0 to 100, with higher scores indicating greater pain and functional impairment.