The Effect of Neurodynamic Exercises and Education Program Applied With Virtual Reality Assisted Telerehabilitation Method in Conservative Treatment of Carpal Tunnel Syndrome: A Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Visual Pain Scale (VAS)
研究概览
简要总结
The aim in this prospective, randomized and controlled, single-blind study; In the conservative treatment of patients diagnosed with carpal tunnel syndrome, to investigate the effects of neurodynamic exercises that applied with nonimmersive virtual reality technology and patient education program presented by the telerehabilitation method on pain-numbness, functional status and quality of life, to compare the effects of neurodynamic exercises that applied with traditional methods and standard education given to patients in outpatient clinic conditions on the same parameters.
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
- Single (Outcomes Assessor)
盲法说明
It was noted to which group the patient was allocated by referring to the list of random numbers created by a computer program by a researcher participating in the study. The treatment process for the intervention group and the control group was managed by the same researcher. Outcome evaluations before treatment and after 8 weeks of treatment follow-up were made by a second researcher who was blind to group distribution. The list of random numbers was hidden from the researcher making the evaluations, ensuring that the participants did not know which group they belonged to. Analysis of the data was done by a third researcher. The intervention group was coded as 'group 1' and the control group was coded as 'group 2'. With this method, it was ensured that the researcher performing the analysis did not know which group the patients belonged to. With this randomization and blinding process, the impartiality of the researchers was ensured.
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
- •18-65 years
- •Being diagnosed with CTS clinically and electrophysiologically
排除标准
- •<18 years or >65 years
- •Distal motor latency > 6.0 msn.
- •Thenar atrophy
- •Surgery history for CTS
- •Steroid injection for CTS
- •Physical treatment for CTS in the last 6 months
- •Cervical radiculopathy
- •Tenosynovitis
- •Peripheral polyneuropathy
- •Another compressive neuropathy in the ipsilateral upper extremity
- •History of trauma/fracture to the hand-wrist region
- •Pregnancy
- •Metabolic disease
- •Rheumatic/autoimmune disease
- •Kidney failure
- •Lack of internet access
- •Not having the equipment to make video calls at home
结局指标
主要结局
Change in Visual Pain Scale (VAS)
时间窗: baseline, eight week of intervention, sixteen week of intervention
The VAS is a single-item measure, that is, an instrument measuring the whole construct at once. VAS most commonly consists of a 100mm horizontal line anchored with two opposite labels; patients mark a score on the scale using a vertical line. Using this scale, patients will be asked to rate the severity of pain and numbness they feel during the night and in daytime at rest, and with activity between 0 and 100 points.
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
时间窗: baseline, eight week of intervention, sixteen week of intervention
BCTSQ assesses the severity of symptoms and functional status in patients with carpal tunnel syndrome. The symptom severity scale assesses the symptoms with respect to severity, frequency, time and type. The scale consists of 11 questions with multiple-choice responses, scored from 1 point (mildest) to 5 points (most severe). The overall symptom severity score is calculated as the mean of the scores for the eleven individual items. The functional status scale assesses the affect of the carpal tunnel syndrome on daily living. The scale consists of 8 questions with multiple choice responses, scored from 1 point (no difficulty with the activity) to 5 points (can not perform the activity at all). The overall score for functional status was calculated as the mean of all eight. Thus, a higher symptom severity or functional status score indicates worse symptoms or dysfunction.
次要结局
- Change in Hand Grip Force(baseline, eight week of intervention, sixteen week of intervention)
- Change in Vibration Sensation(baseline, eight week of intervention, sixteen week of intervention)
- Change in Nerve Conduction Study (NCS)(baseline, eight week of intervention, sixteen week of intervention)
- Change in Brief International Classification of Functioning (ICF) Core Set for Hand Conditions Questionnaire(baseline, eight week of intervention, sixteen week of intervention)
- Change in Short Form-36 (SF-36) Questionnaire(baseline, eight week of intervention, sixteen week of intervention)
- Change in Semmes Weinstein Monofilament Test (SWMT)(baseline, eight week of intervention, sixteen week of intervention)
- Change in Manuel Muscle Testing of M. Abductor Pollicis Brevis(baseline, eight week of intervention, sixteen week of intervention)
- Change in Two Point Discrimination Test (TPDT)(baseline, eight week of intervention, sixteen week of intervention)
- Change in Thumb and Forefinger Pinch Force(baseline, eight week of intervention, sixteen week of intervention)
研究者
Baran Sezgin
Principal Investigator
Istanbul University