The Effects of Repetitive Peripheral Magnetic Stimulation on Clinical and Electrophysiological Parameters in Patients With Carpal Tunnel Syndrome: A Double-Blind, Randomized, Sham-Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS)
概览
简要总结
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, resulting from compression of the median nerve at the wrist. It is particularly common in middle-aged women. In the early stages, these patients frequently experience pain and numbness in the hand, especially in the first three fingers, and paresthesias, which often worsen at night. As the disease progresses, muscle weakness and atrophy of the thenar muscles can occur, severely impacting patients' daily activities and functionality. Clinical evaluation and patient complaints are crucial for diagnosis. Electrophysiological assessment tools such as nerve conduction studies and electromyography (EMG) are highly sensitive and considered the gold standard for confirming the diagnosis, assessing nerve damage, and determining the severity of this damage. In addition to electrophysiological assessment, ultrasonographic evaluation offers an important opportunity to observe structural changes in the median nerve associated with CTS.
In cases of mild to moderate CTS, nonsurgical treatments are the primary options for reducing symptoms; splinting, tendon-nerve gliding exercises, and physical therapy modalities are commonly preferred. Repetitive peripheral magnetic stimulation (rPMS) is a non-invasive method that can be applied to various tissues, such as spinal nerves, peripheral nerves, or muscles, and is used to reduce pain and improve motor function. While its potential benefits for many neurological diseases and musculoskeletal problems have been demonstrated in recent years, there are limited studies on the effectiveness of rPMS in patients with CTS. The primary objective of this study is to evaluate the effectiveness of rPMS on pain in individuals diagnosed with mild to moderate CTS. Secondarily, the effects of rPMS on symptom severity, functional status, nerve conduction parameters, and median nerve ultrasonographic findings will be analyzed. The findings of our study suggest that objective evaluation of rPMS treatment will contribute to supporting the clinical practice of this treatment option in patients with CTS with more comprehensive data.
详细描述
This study is designed as a prospective, randomized, sham-controlled, double-blind, experimental study. It was approved by the Ethics Committee of Ankara University, Faculty of Medicine, and will be conducted in accordance with the Declaration of Helsinki. The study will be conducted at the Department of Physical Medicine and Rehabilitation, Ankara University Faculty of Medicine Hospital. Eligible participants who are over 18 years of age, have provided informed consent, and have clinical symptoms and physical examination findings consistent with carpal tunnel syndrome (CTS), along with electrodiagnostic confirmation of mild to moderate CTS, will be enrolled. Participants will randomly be assigned to two groups: a treatment group and a sham group. Randomization will be performed using the Random Allocation Software (RAS) program. All patients will be instructed in tendon and nerve gliding exercises by a physiotherapist. In addition to these exercises, the treatment group will undergo repetitive peripheral magnetic stimulation (rPMS) therapy three times per week for two consecutive weeks, for a total of six sessions. Each session will last 10 minutes. rPMS will be applied by a physiotherapist who is blinded to the participants' diagnoses and outcome evaluations. All participants will be carefully monitored throughout the intervention period. Assessments will be conducted at three time points: baseline, three weeks after the final treatment session, and six weeks post-treatment. Participants will be assessed by Dr. Sema Köylü Dağ, who will be blinded to patient group allocation and diagnosis, using the case report form. In line with this form, sociodemographic data, including age, sex, height, weight, body mass index (BMI), marital status, educational level, occupation, and contact information, will be recorded, along with medical history, symptom duration, smoking status, dominant hand, and affected hand. Assessments will include the Visual Analog Scale (VAS), grip and pinch strength measurements (kg), the Boston Carpal Tunnel Questionnaire (BCTQ), the Short Form-36 Health Survey (SF-36), electrophysiological evaluation of the median nerve, and ultrasonographic cross-sectional area measurement (mm²) of the median nerve.
Statistical Analysis Sample size was calculated based on the primary endpoint: detecting a clinically meaningful difference in Visual Analog Scale (VAS) scores between the two groups, with a mean effect size of 1.4. Assuming a significance level of α = 0.05 and power = 0.95, the required sample size was calculated as 15 patients per group (30 patients in total). Calculations were performed using the GPower 3.1 software. Considering possible dropouts, the plan is to recruit 20 participants per group, totaling 40 patients.
Descriptive statistics will be presented as mean ± standard deviation, median (minimum-maximum), and frequency (percentage).
For between-group comparisons, Student's t-test and chi-square test will be used.
For within-group comparisons, repeated measures ANOVA or the Friedman test will be employed.
Correlations between variables will be analyzed using Pearson correlation coefficient.
A p-value < 0.05 will be considered statistically significant
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation with signed informed consent
- •Presence of symptoms consistent with carpal tunnel syndrome (CTS) (pain and/or paresthesia in the median nerve distribution), clinical signs (i.e., positive Tinel's and/or Phalen's test results), and electrodiagnostic findings (demonstrating mild to moderate CTS based on sensory or motor conduction studies of the median nerve)
排除标准
- •Electrodiagnostic evidence of severe CTS
- •Abnormal ulnar nerve conduction findings
- •History of surgery for CTS
- •History of physical therapy or injection for CTS within the past 6 months
- •History of wrist fracture
- •Presence of other conditions causing similar symptoms, such as polyneuropathy, cervical radiculopathy, ulnar neuropathy, brachial plexopathy, or thoracic outlet syndrome
- •Central nervous system disorders (e.g., stroke, multiple sclerosis, Parkinson's disease)
- •Pregnancy
- •Presence of risk factors for CTS such as rheumatologic diseases, chronic kidney disease, diabetes mellitus, or hypothyroidism
- •Malignancy
研究组 & 干预措施
rPMS group
All patients will be instructed in tendon and nerve gliding exercises by a physiotherapist. In addition to these exercises, the treatment group will undergo repetitive peripheral magnetic stimulation (rPMS) therapy three times per week for two consecutive weeks, for a total of six sessions. Each session will last 10 minutes
干预措施: rPMS group (Device)
sham- rPMS group
All patients will be instructed in tendon and nerve gliding exercises by a physiotherapist. In addition to these exercises, the sham-rPMS group will receive sham repetitive peripheral magnetic stimulation (rPMS) therapy, three times per week for two weeks, totaling six sessions. Each session will last 10 minutes. Patients will be positioned identically, and the device will be placed in the same position but not activated. Instead, previously recorded operational sounds of the device will be played back during the same duration to simulate the treatment experience.
干预措施: sham-rPMS (Device)
结局指标
主要结局
Visual analog scale (VAS)
时间窗: Baseline, three weeks after the final treatment session, and six weeks post-treatment.
The Visual Analog Scale is a tool used to quantitatively assess pain intensity. It consists of a 10 cm horizontal line, with opposing descriptors at each end. The left end represents "no pain," and the right end represents "worst imaginable pain." Patients are asked to mark a point along the line that best represents the average level of pain they experience. The distance from the left endpoint to the point marked by the participant will be measured in centimeters and recorded as a VAS pain score.
次要结局
- Grip and Pinch Strength Assessment(baseline, three weeks after the final treatment session, and six weeks post-treatment.)
- Boston Carpal Tunnel Questionnaire (BCTQ)(baseline, three weeks after the final treatment session, and six weeks post-treatment.)
- SF-36 (Short Form-36 Health Survey Questionnaire)(baseline, three weeks after the final treatment session, and six weeks post-treatment.)
- Electrophysiological Evaluation(baseline, three weeks after the final treatment session, and six weeks post-treatment.)
- Ultrasonographic Measurement of Median Nerve Cross-Sectional Area(baseline, three weeks after the final treatment session, and six weeks post-treatment.)
研究者
Seçilay Güneş
Associated Professor
Ankara University