Magnetotherapy, Lateral Epicondylitis (Tennis Elbow)
Conditions
Keywords
magnetotherapy, lateral epicondylitis, tennis elbow
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.
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.
Interventions
DEVICEPulsed 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 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.
Sponsors
Fatih Sultan Mehmet Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
both teh researcher/evaluator and the particapant are blind
Intervention model description
prospective, randomized, placebo-controlled, double-blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12 | 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. |
| Change in Pressure Pain Threshold Measured by Algometer | Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12) | 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. |
| Change in Grip Strength Measured by Hand Dynamometer | Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12) | 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. |
| Change in Functional Status Measured by PRTEE Score | Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Disability Measured by QuickDASH | Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12) | 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. |
| Change in Health-Related Quality of Life Measured by SF-36 | Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12) | 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. |
| Change in Clinical Provocation Test Results (Cozen, Mill's, Maudsley's Tests) | Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12) | 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. |
| Patient Satisfaction Measured by 5-Point Likert Scale | Post-treatment (Week 3) and Follow-up (Week 12) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSelda Pur Uğur, Medical Doctor
CONTACTFeyza Ünlü Özkan, Medical Doctor
Outcome results
None listed