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MagnetotherapyMAGNET-LENCT07444996

Effect of Magnetotherapy Combined With Cold Application and Exercise in Patients With Lateral Epicondylitis

A study testing Pulsed Electromagnetic Field Therapy (Magnetotherapy) in people with Magnetotherapy and Lateral Epicondylitis (Tennis Elbow), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Pulsed Electromagnetic Field Therapy (Magnetotherapy)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 Feb 2026to 27 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Selda Pur Uğur, Medical Doctor contact

905376755732

seldapurr@gmail.com

Feyza Ünlü Özkan, Medical Doctor contact

905324090942

feyzamd@yahoo.com

Turkey (Türkiye)1 site
  • Fatih Sultan Mehmet Reasearch and Training Hospital

    Istanbul, 34734

    Selda Pur Uğur, Medical doctor, 905376755732, seldapurr@gmail.com

    Feyza Ünlü Özkan, Medical doctor, 905324090942, feyzamd@yahoo.com

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Pulsed Electromagnetic Field Therapy (Magnetotherapy), Sham Pulsed Electromagnetic Field Therapy
Keywords
magnetotherapy, lateral epicondylitis, tennis elbow
Medical subject headings
Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulsed Electromagnetic Field Therapy (Magnetotherapy)Device

    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 Pulsed Electromagnetic Field TherapyDevice

    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.

Study groups in NCT07444996
Study groupRoleWhat they receive
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.
Receives: Device: Pulsed Electromagnetic Field Therapy (Magnetotherapy)
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
Receives: Device: Sham Pulsed Electromagnetic Field Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12

  2. 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.

    Measured: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)

  3. 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.

    Measured: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)

  4. 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.

    Measured: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)

Secondary outcomes (4)
  1. 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.

    Measured: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)

  2. 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.

    Measured: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)

  3. 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.

    Measured: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)

  4. 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.

    Measured: Post-treatment (Week 3) and Follow-up (Week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start27 Feb 2026 (estimated)
  3. Primary completion27 Jun 2026 (estimated)
  4. Study completion27 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, randomized, placebo-controlled, double-blind study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07444996
Sponsor's protocol ID
2024-KAEK-36
Acronym
MAGNET-LE
Status last verified
Feb 2026
First submitted
25 Feb 2026
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared publicly. All collected data will be de-identified and analyzed for scientific publication purposes only.

Questions about this trial

What is this clinical trial studying?

A study testing Pulsed Electromagnetic Field Therapy (Magnetotherapy) in people with Magnetotherapy and Lateral Epicondylitis (Tennis Elbow), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Selda Pur Uğur, Medical Doctor (905376755732, seldapurr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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