Evaluation of the Effectiveness of Splint Use in Different Wrist Positions in the Treatment of Carpal Tunnel Syndrome: A Single-Blind, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- Nerve Conduction Study (NCS)
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the most common nerve compression syndrome. It develops as a result of the compression of the median nerve while passing through the osteofibrous structure of the carpal tunnel located at the wrist. Sensory symptoms are the most prominent feature of CTS. These symptoms are observed as pain, paresthesia, and decreased sensory sensitivity. As motor symptoms, thumb abduction and opposition are primarily affected. In advanced cases, atrophy develops in the thenar muscles. Patients may describe weakness as difficulty in writing, opening jars, buttoning, or grasping objects. The diagnosis is made by fulfilling both clinical and electrophysiological diagnostic criteria. CTS has both conservative and surgical treatment options. Conservative treatment includes splinting, physical therapy modalities, and injection options, and it is preferred in mild and moderate cases. Among non-surgical treatment options, splint use is a commonly applied intervention; however, there is no consensus regarding its effectiveness, the optimal wrist position during use, or the duration and frequency of splint application. A total of 108 hands from patients aged 18 to 55 years diagnosed with CTS will be included in this study and randomized into three groups. All groups will be given an education and exercise program. The first group will use a wrist splint fixed at 15° flexion; the second group at neutral position; and the third group at 20° extension, to be worn only at night for eight weeks. Patients will be evaluated before treatment, immediately after treatment, and two months after the end of treatment using measures of pain- numbness severity, functional status, motor and sensory examination findings, and nerve conduction studies. What makes this study unique is that it evaluates the effects of splints that stabilize the wrist at different angles together with electrophysiological findings. A review of the literature shows that while some studies have examined and compared the effects of splints fixed at different wrist angles on symptoms, functional status, and physical examination findings, there is no study that evaluates these effects along with electrophysiological findings. Therefore, this study, which will compare the effectiveness of splints at different angles, is expected to contribute to the literature. The expected outcomes of this research are that one or more types of splints used in the conservative treatment of CTS will provide improvements in symptom severity, functional status, sensory and motor physical examination findings, and electrophysiological evaluation findings at the end of treatment.
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)
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
- •Diagnosis of mild to moderate carpal tunnel syndrome confirmed by electrophysiological studies performed within the last year.
- •Clinical findings consistent with carpal tunnel syndrome.
- •Age between 18 and 65 years.
排除标准
- •<18 years or >65 years
- •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
研究组 & 干预措施
15° Flexion Wrist Splint Group
干预措施: Flexion Splint (Other)
15° Flexion Wrist Splint Group
干预措施: Education (Behavioral)
15° Flexion Wrist Splint Group
干预措施: Exercise (Other)
Neutral Wrist Splint Group
干预措施: Neutral Splint (Other)
Neutral Wrist Splint Group
干预措施: Education (Behavioral)
Neutral Wrist Splint Group
干预措施: Exercise (Other)
20° Extension Wrist Splint Group
干预措施: Extension Splint (Other)
20° Extension Wrist Splint Group
干预措施: Education (Behavioral)
20° Extension Wrist Splint Group
干预措施: Exercise (Other)
结局指标
主要结局
Nerve Conduction Study (NCS)
时间窗: Baseline and sixteen week of intervention
Median motor distal latency and conduction velocity and second finger recorded median sensory distal latency and conduction velocity will be measured in all individuals. In addition to routine conduction examinations, fourth finger recorded median-ulnar peak latency comparison examinations will also be made.
次要结局
- Visual Pain Scale (VAS)(Baseline, eight week of intervention, sixteen week of intervention)
- Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)(Baseline, eight week of intervention, sixteen week of intervention)
- Semmes Weinstein Monofilament Test (SWMT)(Baseline, eight week of intervention, sixteen week of intervention)
- Two Point Discrimination Test (TPDT)(Baseline, eight week of intervention, sixteen week of intervention)
- Hand Grip Force(Baseline, eight week of intervention, sixteen week of intervention)
- Thumb and Forefinger Pinch Force(Baseline, eight week of intervention, sixteen week of intervention)
- Manuel Muscle Testing of M. Abductor Pollicis Brevis(Baseline, eight week of intervention, sixteen week of intervention)
- Vibration Sensation(Baseline, eight week of intervention, sixteen week of intervention)
研究者
Fatma Merih Akpınar
Assistant Professor
Istanbul University
