Pulsed Electromagnetic Field Therapy Added to ESWT for Lateral Epicondylitis

NCT07802938 | Not Yet Recruiting

• 1 other identifier: HU-KAEK-2026-00076
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Lateral Epicondylitis; Extracorporeal Shock Wave Therapy; ESWT; Pulsed Electromagnetic Field Therapy; PEMF; Patient-Rated Tennis Elbow Evaluation

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, end of the 5-week treatment period, and 3 months after treatment completion

• Change in PRTEE Pain Subscale Score

  The PRTEE pain subscale consists of 5 items and ranges from 0 to 50, with higher scores indicating greater pain.

  Baseline, end of the 5-week treatment period, and 3 months after treatment completion

• Change in PRTEE Function Subscale Score

  The PRTEE function subscale consists of 10 items and ranges from 0 to 50, with higher scores indicating greater functional impairment.

  Baseline, end of the 5-week treatment period, and 3 months after treatment completion

Secondary Outcomes (7)

• Change in Pain Intensity Measured by the Numeric Rating Scale

  Baseline, end of the 5-week treatment period, and 3 months after treatment completion

• Change in Pressure Pain Threshold

  Baseline, end of the 5-week treatment period, and 3 months after treatment completion

• Change in Maximum Grip Strength

  Baseline, end of the 5-week treatment period, and 3 months after treatment completion

• Change in Pain-Free Grip Strength

  Baseline, end of the 5-week treatment period, and 3 months after treatment completion

• Change in Common Extensor Tendon Thickness

  Baseline, end of the 5-week treatment period, and 3 months after treatment completion

Study Arms (2)

ESWT + Active PEMF

EXPERIMENTAL

Participants will receive active pulsed electromagnetic field therapy (PEMF) followed by extracorporeal shock wave therapy (ESWT) once weekly for 5 weeks. All participants will also receive the same standardized home exercise program.

Device: Pulsed Electromagnetic Field Therapy; Device: Extracorporeal Shock Wave Therapy; Behavioral: Home Exercise Program

ESWT + Sham PEMF

SHAM COMPARATOR

Participants will receive sham pulsed electromagnetic field therapy (PEMF) followed by the same extracorporeal shock wave therapy (ESWT) protocol once weekly for 5 weeks. The sham device will have the same appearance, sound, and light signals as the active device but will not generate a therapeutic electromagnetic field. All participants will also receive the same standardized home exercise program.

Device: Sham Pulsed Electromagnetic Field Therapy; Device: Extracorporeal Shock Wave Therapy; Behavioral: Home Exercise Program

Interventions

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.

Also known as: PEMF

ESWT + Active PEMF

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.

Also known as: Sham PEMF

ESWT + Sham PEMF

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.

ESWT + Active PEMF; ESWT + Sham PEMF

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.

Also known as: ESWT

ESWT + Active PEMF; ESWT + Sham PEMF

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ali Güneri: lead

MeSH Terms

Conditions

Tennis Elbow

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ali Güneri, MD

  Gaziantep City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Güneri, MD

CONTACT

+90 507 751 20 47; draliguneri@gmail.com

Merve Önoğul Özmen, MD

CONTACT

+90 539 898 14 01; drmerveonogul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to active or sham PEMF allocation. The sham device will provide the same appearance, sound, and light signals as the active device but will not generate a therapeutic electromagnetic field. Outcome assessments will be performed by assessors who are unaware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 2, 2026
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): January 14, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-08