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
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2026
CompletedStudy Start
First participant enrolled
February 27, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 27, 2026
March 9, 2026
February 1, 2026
4 months
February 25, 2026
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
Change in Upper Extremity Disability Measured by QuickDASH
Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)
Change in Health-Related Quality of Life Measured by SF-36
Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)
Change in Clinical Provocation Test Results (Cozen, Mill's, Maudsley's Tests)
Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)
Patient Satisfaction Measured by 5-Point Likert Scale
Post-treatment (Week 3) and Follow-up (Week 12)
Study Arms (2)
Active Comparator: Group 1 (Magnetotherapy Group)
EXPERIMENTALParticipants 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.
Sham Comparator: Group 2 (Placebo Magnetotherapy Group)
SHAM COMPARATORParticipants 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fatih Sultan Mehmet Reasearch and Training Hospital
Istanbul, 34734, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- both teh researcher/evaluator and the particapant are blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 3, 2026
Study Start
February 27, 2026
Primary Completion (Estimated)
June 27, 2026
Study Completion (Estimated)
November 27, 2026
Last Updated
March 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared publicly. All collected data will be de-identified and analyzed for scientific publication purposes only.