Evaluation of The Neuromedulatory Effect of Transcranial Direct Current Electrical Stimulation (tDCS) in Carpal Tunnel Syndrome (CTS): A Double Blinded Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Visual analogue scale (VAS)
研究概览
简要总结
This is a double blinded randomized clinical trial to study the neuromodulatory effect of tDCS in patients with CTS, the study subject will be randomly into two groups; active and sham group , the active group will receive five sessions of active TDCS over the M1 while the Sham group will receive sham tDCS in which the device will be turned off after 30 seconds. The patient will be assessed by VAS score, Boston carpal tunnel questionnaire , central sensetization inventory , pressure pain threshold, sensory and pain threshold for electerical stimulation before , after the end of the sessions and 4 weeks later.
详细描述
The study will be carried out on patients attending the Physical Medicine, Rheumatology and Rehabilitation outpatient clinic in Suez Canal University Hospital, Ismailia, EGYPT and diagnosed with CTS according to clinical examination and to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) practice recommendations for CTS.
Study subjects will be divided into two groups:
Group (1): (active group) will include 42 patients with CTS and will receive anodal tDCS of M1 for 20 minutes, at 2 mA for 5 sessions and less than 72 hrs. may be allowed between experimental sessions for each participant to avoid any interference.
Group (2): (sham group) will include 42 patients with CTS and will receive sham tDCS M1 (the set will be turned off after 30 seconds) for 20 minutes, at 2 mA for 5 sessions.
The study sample will be collected from all patients with CTS attending to the Physical medicine, Rheumatology and Rehabilitation outpatient clinic in Suez Canal University Hospital fulfilling the eligibility criteria, will be eligible to join the study (either referred for electrophysiological study or presented to the clinic for primary assessment). To make sure that no bias should enter the assessment of the results, neither the patient nor the clinicians will be aware whether active tDCS will be applicated to a particular case. To ensure this result, two symbols (Square and Triangle) will be applicated to the physiotherapy sheet and only the physiotherapist knew the key for each symbol. The triangle may represent the cases of CTS for active tDCS and the square may represent the sham group or vice versa. At the end of the study the two groups will be revealed in order to analyze the results according to proper statistical measures.
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)
盲法说明
To make sure that no bias should enter the assessment of the results, neither the patient nor the clinicians will be aware whether active tDCS will be applicated to a particular case. To ensure this result, two symbols (Square and Triangle) will be applicated to the physiotherapy sheet and only the physiotherapist knew the key for each symbol. The triangle may represent the cases of CTS for active tDCS and the square may represent the sham group or vice versa. At the end of the study the two groups will be revealed in order to analyze the results according to proper statistical measures.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed as CTS by history, clinical examination and NCS for more than 3 months.
- •Both genders. Adult of aged 18 years and above. Able to understand the informed consent.
排除标准
- •Patients with diabetes mellitus, collagen disorders, thyroid disease, peripheral neuropathy, traumatic nerve injury, cervical radiculopathy, fibromyalgia.
- •Pregnancy. Malignant. Patients with any clinically significant or unstable medical or psychiatric disorder.
结局指标
主要结局
Visual analogue scale (VAS)
时间窗: four weeks after the ending of sessions
Visual analogue scale is a measurement instrument that measure the pain across a continuum of values. Visual analogue scale is measured in millimeters and ranged from minimum (0 millimeter) to maximum (100 millimeters), where, score 0 indicates no pain and 100 indicates worst pain ever.
Visual analogue scale
时间窗: before sessions (baseline assessment)
Visual analogue scale is a measurement instrument that measure the pain across a continuum of values. Visual analogue scale is measured in millimeters and ranged from minimum (0 millimeter) to maximum (100 millimeters), where, score 0 indicates no pain and 100 indicates worst pain ever.
Sensory threshold and pain threshold for electrical stimulation
时间窗: four weeks after the ending of sessions
Electrical stimulation will be applied by a pen electrode (model: 2762CC; Chattanooga) to the median nerve (pulse duration - 200 microseconds) at wrist level. Current supply start at 0 milli-ampere and will be increased in steps of 0.1 milli-ampere, until the participant report sensation and pain. The intensity of current (in milli-ampere) at which perception of the electrical stimulus first reported will be taken as sensory threshold; the intensity of current (in milli-ampere) at which participants first reported pain will be taken as pain threshold. These measurements will be averaged for analysis. Both sides will be assessed and compared. The lower the intensity of current (in milli-ampere) perceived, the worse the threshold, while the higher the intensity of current (in milli-ampere) perceived, the better the threshold.
Pressure pain threshold assessment
时间窗: four weeks after the ending of sessions
Pressure will be induced using a pressure algometer (PainTest™ FPN 100 Algometer (Wagner Instruments, Greenwich, USA)) with a flat circular metal probe dressed in a rubber cover with a surface area of 1 cm2 applied to median, ulnar, radial, and c5-6 zygoapophyseal joint, The algometer will be mounted vertically and the pressure will be increased. Patients are asked to notify the investigator when they start to feel pain (pain threshold). For each measurement the algometer will be calibrated to enable force to be applied at a controlled and steady rate, the mean of three trials (intra-examiner reliability) will be calculated and used for main analysis. A 30 seconds resting period will be allowed between each measure. Both sides will be assessed and compared. Abnormal pressure pain threshold is at least 2 kg/cm2 different than that of the opposite site. The lower the value perceived, the worse the threshold, while the higher the value perceived, the better the threshold.
次要结局
- Boston carpal tunnel syndrome questionnaire(four weeks after the ending of sessions)
- Central sensitization inventory(before sessions (baseline assessment))
- Central sensitization inventory (CSI)(four weeks after the ending of sessions)
研究者
Gehad Swilam Abdelmonem Swilam
Assistant Lecturer
Suez Canal University