Effect of Two Different Kinesiotaping Techniques Added to Exercise on Clinical, Functional, and Ultrasonographic Outcomes in Carpal Tunnel Syndrome: A Randomized Controlled, Evaluator-Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Median Nerve Flattening Ratio (FR)
研究概览
简要总结
This study aims to evaluate the clinical, functional, and ultrasonographic effects of two different kinesiotaping techniques added to a standard exercise and night splint program in the treatment of Carpal Tunnel Syndrome (CTS). Participants will be randomly assigned to one of three groups: the I-Strip kinesiotaping technique group, the Button Hole kinesiotaping technique group, or a control group receiving only standard therapy. The study will assess treatment outcomes over a 12-week period using high-resolution ultrasound (specifically median nerve cross-sectional area and flattening ratio) and clinical parameters to determine the most effective conservative management approach.
详细描述
Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy, typically managed conservatively with tendon and nerve gliding exercises alongside night splints. Recently, Kinesiotaping (KT) has gained popularity for its space-correction mechanism, which aims to increase microcirculation and reduce mechanical pressure on the median nerve. While immediate effects of KT have been studied, there is a lack of literature comparing the long-term structural and clinical effects of specific taping methods.
This prospective, randomized controlled, evaluator-blinded trial is designed to compare the 12-week efficacy of the original "I-Strip" and "Button Hole" kinesiotaping techniques when combined with standard exercise and splint therapy, against a standard therapy-only control group.
The primary objective is to investigate morphological changes in the median nerve using high-resolution neurosonography, specifically tracking the Cross-Sectional Area (CSA) and Flattening Ratio (FR) at the carpal tunnel inlet. Secondary objectives include evaluating improvements in pain and upper extremity functionality. By objectively monitoring structural recovery through dynamic ultrasound imaging, this study aims to provide evidence-based recommendations on the long-term anatomical and clinical benefits of different kinesiotaping applications in CTS management.
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
- •Being aged between 18 and 65 years.
- •Willingness and ability to sign the informed consent form.
- •Having symptoms of carpal tunnel syndrome (hand numbness, tingling, pain) for at least 3 months.
- •Clinical diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by physical examination (positive Phalen/Tinel tests) and a prior nerve conduction study (EMG).
排除标准
- •Previous wrist or hand surgery.
- •Severe carpal tunnel syndrome on EMG (evidence of thenar atrophy or severe motor loss).
- •History of trauma, fracture in the wrist area, or anatomical anomalies affecting ultrasonography.
- •Cervical radiculopathy, polyneuropathy, diabetic neuropathy, or other concomitant upper extremity entrapment neuropathies.
- •Local corticosteroid injection to the carpal tunnel within the last 6 months.
- •Pregnancy.
- •Systemic corticosteroid use or inflammatory rheumatic diseases.
- •Cognitive impairment or psychiatric illness preventing comprehension of questionnaire instructions.
- •Lack of a prior EMG report upon admission to the outpatient clinic.
研究组 & 干预措施
I-Strip Kinesiotaping Group
Participants will receive the original I-Strip kinesiotaping technique combined with standard exercise and a night splint program.
干预措施: I-Strip Kinesiotaping and Standard Therapy (Other)
I-Strip Kinesiotaping Group
Participants will receive the original I-Strip kinesiotaping technique combined with standard exercise and a night splint program.
干预措施: Standard Exercise and Splint Therapy (Other)
Button Hole Kinesiotaping Group
Participants will receive the Button Hole kinesiotaping technique combined with standard exercise and a night splint program.
干预措施: Button Hole Kinesiotaping and Standard Therapy (Other)
Button Hole Kinesiotaping Group
Participants will receive the Button Hole kinesiotaping technique combined with standard exercise and a night splint program.
干预措施: Standard Exercise and Splint Therapy (Other)
Control Group
Participants will only receive a standard exercise and overnight splint program.
干预措施: Standard Exercise and Splint Therapy (Other)
结局指标
主要结局
Median Nerve Flattening Ratio (FR)
时间窗: At baseline (T0), 3rd week (T1), and 12th week (T2)
Measurements will be taken at the pisiform bone level using resolution ultrasound.
Median Nerve Cross-Sectional Area (CSA)
时间窗: At baseline (T0), 3rd week (T1), and 12th week (T2)
Using high-resolution ultrasound, measurements will be taken in millimeters square (mm2) at the pisiform bone level.
次要结局
- Visual Analog Scale (VAS) for Pain (Rest and activity pain intensity, 0-10 cm)(At baseline (T0), 3rd week (T1), and 12th week (T2))
- Douleur Neuropathique 4 (DN4) Questionnaire Score(At baseline (T0), 3rd week (T1), and 12th week (T2))
- Jamar Dynamometer Grip Strength in Kilograms (kg)(At baseline (T0), 3rd week (T1), and 12th week (T2))
- Visual Analog Scale (VAS) for Numbness/Paresthesia (Median nerve trajectory, 0-10 cm)(At baseline (T0), 3rd week (T1), and 12th week (T2))
- Boston Carpal Tunnel Questionnaire (BCTQ) for Symptom Severity and Functional Status(At baseline (T0), 3rd week (T1), and 12th week (T2))
研究者
Furkan Erdinc, MD
Medical Doctor
Kayseri City Hospital