Effect of Magnetotherapy Combined With Cold Application and Exercise in Patients With Lateral Epicondylitis (MAGNET-LE)

Effectiveness of Magnetotherapy in Patients With Lateral Epicondylitis: A Randomized Double-Blind Controlled Trial

This study aims to evaluate the effectiveness of magnetotherapy in the treatment of lateral epicondylitis (tennis elbow). Lateral epicondylitis is a common musculoskeletal condition characterized by pain and tenderness over the outer part of the elbow, often associated with repetitive wrist extension and gripping activities. It may cause reduced grip strength, functional limitations, and decreased quality of life.

In this prospective, randomized, double-blind, sham-controlled clinical trial, 40 patients aged 18-65 years diagnosed with lateral epicondylitis will be enrolled. Participants will be randomly assigned into two groups using the sealed envelope method.

The experimental group will receive active magnetotherapy in addition to standard treatment (local application and supervised exercise therapy). The control group will receive sham magnetotherapy (inactive device without magnetic field) plus the same standard treatment. Treatments will be administered five days per week for three weeks.

Magnetotherapy will be applied at a frequency of 50 Hz and intensity of 85 Gauss for 30 minutes per session. All participants will also receive 15 minutes of local application and 15 minutes of supervised exercises including eccentric wrist extensor exercises, isotonic strengthening, stretching, and isometric exercises.

Outcomes will be evaluated at baseline (week 0), at the end of treatment (week 3), and at follow-up (week 12). Primary and secondary outcome measures include pain intensity (Visual Analog Scale), pressure pain threshold (algometer), grip strength (hand dynamometer), functional status (PRTEE and QuickDASH questionnaires), quality of life (SF-36), clinical provocation tests (Cozen, Mill's, and Maudsley's tests), and patient satisfaction (Likert scale).

The study hypothesis is that adding magnetotherapy to standard treatment will provide additional benefit in reducing pain and improving function compared to standard treatment alone.

Study Overview

• Status: Not yet recruiting
• Conditions: Lateral Epicondylitis (Tennis Elbow); Magnetotherapy
• Intervention / Treatment: Device: Pulsed Electromagnetic Field Therapy (Magnetotherapy); Device: Sham Pulsed Electromagnetic Field Therapy

Detailed Description

Lateral epicondylitis, commonly known as tennis elbow, is a frequently encountered musculoskeletal disorder characterized by pain and tenderness over the lateral epicondyle of the elbow. It is typically associated with repetitive wrist extension and gripping activities and primarily involves tendinopathy of the extensor carpi radialis brevis tendon. The condition most commonly affects individuals between 30 and 55 years of age and may lead to decreased grip strength, impaired upper extremity function, and reduced quality of life.

Conservative management remains the first-line treatment and includes activity modification, nonsteroidal anti-inflammatory drugs, physical therapy modalities, and therapeutic exercise. Eccentric strengthening of the wrist extensors is considered a cornerstone of rehabilitation. Various physical therapy modalities such as ultrasound, iontophoresis, extracorporeal shock wave therapy, laser therapy, kinesiotaping, and acupuncture have been studied with varying levels of evidence.

Magnetotherapy (pulsed electromagnetic field therapy - PEMF) is a noninvasive modality that exerts biological effects at the cellular level. It has been reported to influence membrane ion transport, stimulate cellular metabolism, promote tissue regeneration, and demonstrate anti-inflammatory and analgesic effects. Although magnetotherapy has been investigated in several musculoskeletal conditions, evidence regarding its effectiveness in lateral epicondylitis remains limited, particularly in randomized double-blind controlled trials.

This study aims to evaluate whether adding magnetotherapy to a standard rehabilitation program provides additional benefit in reducing pain and improving function in patients with lateral epicondylitis.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Selda Pur Uğur, Medical doctor; Phone Number: 905376755732; Email: seldapurr@gmail.com
• Study Contact Backup: Name: Feyza Ünlü Özkan, Medical doctor; Phone Number: 905324090942; Email: feyzamd@yahoo.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34734
    • Fatih Sultan Mehmet Reasearch and Training Hospital
    • Sub-Investigator: Feyza Ünlü Özkan, Medical Doctor
    • Contact: Selda Pur Uğur, Medical doctor; Phone Number: 905376755732; Email: seldapurr@gmail.com
    • Contact: Feyza Ünlü Özkan, Medical doctor; Phone Number: 905324090942; Email: feyzamd@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 65 years
• Clinical diagnosis of lateral epicondylitis
• Tenderness over the lateral epicondyle on palpation
• Tenderness over the common extensor tendon
• At least one positive provocation test (Cozen, Mill's, or Maudsley's test)
• Willingness to participate and provide written informed consent

Exclusion Criteria:

• Acute infection
• Elbow surgery within the past 12 months
• Presence of electronic implants (e.g., pacemaker, cochlear implant)
• Pregnancy
• Physical therapy for the elbow within the past 3 months
• Corticosteroid injection to the elbow within the past 3 months
• History of elbow trauma within the past 3 months
• Hyperthyroidism or adrenal hyperfunction
• Paroxysmal neurological disorders (e.g., epilepsy)
• Myasthenia gravis
• Inability to comply with the treatment protocol or follow-up assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Comparator: Group 1 (Magnetotherapy Group); Participants receive active pulsed electromagnetic field (PEMF) therapy (50 Hz, 85 Gauss, 30 minutes per session), five days per week for three weeks. In addition, all participants receive 15 minutes of local application and 15 minutes of supervised exercise therapy including eccentric wrist extensor exercises, isotonic strengthening, stretching, and isometric exercises.	Device: Pulsed Electromagnetic Field Therapy (Magnetotherapy); Active pulsed electromagnetic field (PEMF) therapy applied to the lateral epicondyle region using a device delivering 50 Hz frequency and 85 Gauss intensity for 30 minutes per session. Treatment is administered five days per week for three consecutive weeks. The device generates an active magnetic field. All participants additionally receive 15 minutes of local application and 15 minutes of supervised therapeutic exercise including eccentric wrist extensor exercises, isotonic strengthening, stretching, and isometric exercises.
Sham Comparator: Sham Comparator: Group 2 (Placebo Magnetotherapy Group); Participants receive sham magnetotherapy using an identical device that does not emit a magnetic field (30 minutes per session), five days per week for three weeks. In addition, all participants receive 15 minutes of local application and 15 minutes of supervised exercise therapy including eccentric wrist extensor exercises, isotonic strengthening, stretching, and isometric exercises	Device: Sham Pulsed Electromagnetic Field Therapy; Sham pulsed electromagnetic field therapy applied to the lateral epicondyle region using an identical device that does not emit a magnetic field. The procedure duration (30 minutes per session), frequency (five days per week), and total treatment period (three weeks) are identical to the active intervention to maintain blinding. Participants additionally receive 15 minutes of local application and 15 minutes of supervised therapeutic exercise including eccentric wrist extensor exercises, isotonic strengthening, stretching, and isometric exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity Measured by Visual Analog Scale (VAS)	Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Pain will be evaluated both at rest and during activity. The primary endpoint is the change in VAS score from baseline to post-treatment and follow-up. Lower scores indicate reduced pain severity.	Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12
Change in Pressure Pain Threshold Measured by Algometer	Pressure pain threshold over the lateral epicondyle will be measured using a standardized digital algometer (kg/cm²). Controlled pressure will be applied to the most tender point, and the value at which pain is first perceived will be recorded. Higher values indicate improved pain tolerance. The primary endpoint is the change from baseline.	Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)
Change in Grip Strength Measured by Hand Dynamometer	Grip strength will be assessed using a JAMAR® hand dynamometer with the patient seated, shoulder adducted, elbow flexed at 90°, and forearm in neutral position. Both affected and unaffected sides will be measured. The primary endpoint is the change in grip strength of the affected side from baseline. Higher values indicate improvement.	Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)
Change in Functional Status Measured by PRTEE Score	Functional disability will be evaluated using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire. The PRTEE consists of 15 items assessing pain and functional limitations, with total scores ranging from 0 to 100. Higher scores indicate greater pain and disability. The primary endpoint is the change in total PRTEE score from baseline.	Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Upper Extremity Disability Measured by QuickDASH	Upper extremity functional disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. The instrument consists of 11 items evaluating physical function and symptoms related to the upper limb. Scores range from 0 to 100, with higher scores indicating greater disability. The outcome measure is the change in total score from baseline.	Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)
Change in Health-Related Quality of Life Measured by SF-36	Quality of life will be evaluated using the Short Form-36 (SF-36) questionnaire, which includes eight subdomains assessing physical and mental health status. Scores range from 0 to 100 for each domain, with higher scores indicating better health-related quality of life. The outcome measure is the change in domain scores from baseline.	Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)
Change in Clinical Provocation Test Results (Cozen, Mill's, Maudsley's Tests)	Clinical provocation tests specific to lateral epicondylitis (Cozen, Mill's, and Maudsley's tests) will be performed to evaluate pain provocation. A reduction in pain response during these tests will be considered clinical improvement. Results will be recorded as positive or negative findings.	Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)
Patient Satisfaction Measured by 5-Point Likert Scale	Patient satisfaction with treatment will be assessed using a 5-point Likert scale ranging from 1 (not satisfied at all) to 5 (completely satisfied). Higher scores indicate greater satisfaction with the intervention.	Post-treatment (Week 3) and Follow-up (Week 12)

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 27, 2026
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): November 27, 2026

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: tennis elbow; lateral epicondylitis; magnetotherapy
• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow; Therapeutics; Magnetic Field Therapy
• Other Study ID Numbers: 2024-KAEK-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly. All collected data will be de-identified and analyzed for scientific publication purposes only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No