Pulsed Electromagnetic Field Therapy Added to ESWT for Lateral Epicondylitis

ConditionLateral Epicondylitis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorAli Güneri

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Pulsed Electromagnetic Field Therapy
Device
Active pulsed electromagnetic field therapy will be applied before each ESWT session for 30 minutes, once weekly for 5 weeks. According to the study protocol, PEMF will be delivered at 25 Hz and 4.6 Hz sequentially, with a total of 6 mT per session.
Sham Pulsed Electromagnetic Field Therapy
Device
Sham PEMF will be applied before ESWT using the same duration and positioning as active PEMF. The device will have the same appearance, sound, and light signals as the active device but will not generate a therapeutic electromagnetic field.
Extracorporeal Shock Wave Therapy
Device
Extracorporeal shock wave therapy will be applied to the point of maximum tenderness over the lateral epicondyle using 2000 shocks per session at 1.5-2.0 bar and 10 Hz, once weekly for 5 weeks. Transmission gel will be used and local anesthesia will not be administered.
Home Exercise Program
Behavioral
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.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: ESWT + Active PEMFExperimental treatment 3 interventions

Group B: ESWT + Sham PEMFSham comparator 3 interventions

Trial 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.

Time frame