Effectiveness of Magnetotherapy in Patients With Lateral Epicondylitis: A Randomized Double-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
both teh researcher/evaluator and the particapant are blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active Comparator: Group 1 (Magnetotherapy Group)
Participants 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.
干预措施: Pulsed Electromagnetic Field Therapy (Magnetotherapy) (Device)
Sham Comparator: Group 2 (Placebo Magnetotherapy Group)
Participants 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
干预措施: Sham Pulsed Electromagnetic Field Therapy (Device)
结局指标
主要结局
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
selda pur uğur
medical doctor
Fatih Sultan Mehmet Training and Research Hospital