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

Official title

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

Overview

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

• 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, stre
• 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, isotoni

Primary outcome measures

• Change in Pain Intensity Measured by Visual Analog Scale (VAS) [Time frame: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12]
• Change in Pressure Pain Threshold Measured by Algometer [Time frame: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)]
• Change in Grip Strength Measured by Hand Dynamometer [Time frame: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)]
• Change in Functional Status Measured by PRTEE Score [Time frame: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)]

Secondary outcome measures (4)

• Change in Upper Extremity Disability Measured by QuickDASH [Time frame: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)]
• Change in Health-Related Quality of Life Measured by SF-36 [Time frame: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)]
• Change in Clinical Provocation Test Results (Cozen, Mill's, Maudsley's Tests) [Time frame: Baseline (Week 0), Post-treatment (Week 3), and Follow-up (Week 12)]
• Patient Satisfaction Measured by 5-Point Likert Scale [Time frame: Post-treatment (Week 3) and Follow-up (Week 12)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Fatih Sultan Mehmet Reasearch and Training Hospital — Istanbul

Identifiers

NCT: NCT07444996 · 2024-KAEK-36

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗