Pulsed Electromagnetic Field Therapy Added to ESWT for Lateral Epicondylitis
NCT07802938 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2026-09-03
Summary
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.
Conditions
- Lateral Epicondylitis
Interventions
- DEVICE
-
Pulsed Electromagnetic Field Therapy
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.
- DEVICE
-
Sham Pulsed Electromagnetic Field Therapy
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.
- DEVICE
-
Extracorporeal Shock Wave Therapy
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.
- BEHAVIORAL
-
Home Exercise Program
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.
Sponsors & Collaborators
-
Ali Güneri
lead OTHER
Principal Investigators
-
Ali Güneri, MD · Gaziantep City Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-02
- Primary Completion
- 2027-01-14
- Completion
- 2027-01-14
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