Trials / Not Yet Recruiting
Not Yet RecruitingNCT07444996
Effect of Magnetotherapy Combined With Cold Application and Exercise in Patients With Lateral Epicondylitis
Effectiveness of Magnetotherapy in Patients With Lateral Epicondylitis: A Randomized Double-Blind Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Fatih Sultan Mehmet Training and Research Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2026-02-27
- Primary completion
- 2026-06-27
- Completion
- 2026-11-27
- First posted
- 2026-03-03
- Last updated
- 2026-03-09
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07444996. Inclusion in this directory is not an endorsement.