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临床试验/NCT07539480
NCT07539480进行中(未招募)不适用

Carpal Tunnel Syndrome

Middle East University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

Carpal Tunnel Syndrome (CTS) is one of the most common compressive neuropathies of the upper limb, characterized by pain, numbness, and functional impairment due to median nerve compression at the wrist. Its prevalence is estimated at approximately 4.9%, with higher incidence in populations exposed to repetitive hand movements. The resulting sensory disturbances, grip weakness, and functional limitations significantly affect daily activities and quality of life.

Conservative management remains the first line of treatment for mild to moderate CTS, with therapeutic approaches traditionally including splinting, exercise therapy, nerve mobilization, and patient education. Recent interest has grown around Pain Neuroscience Education (PNE)-an educational strategy that reframes patients' understanding of pain by emphasizing the role of the central nervous system, cognitive factors, and neurophysiological processes. Studies have shown that PNE, particularly when combined with exercise or standard rehabilitation, can reduce symptom severity, improve functional outcomes, and help patients better manage chronic pain by reducing fear and catastrophizing. However, the existing literature notes that research on PNE for CTS is still limited, with some trials suggesting positive outcomes but calling for more high-quality evidence.

In parallel, Kinesio Taping (KT) has gained popularity as a noninvasive intervention believed to enhance circulation, provide proprioceptive input, and support soft tissue mobility. Evidence from randomized controlled trials shows that KT can improve grip strength, reduce pain intensity, enhance sensory conduction velocity, and improve functional status as measured by validated clinical tools such as the Boston Carpal Tunnel Questionnaire. These findings suggest that KT may serve as an effective supplementary therapy in the conservative management of CTS

详细描述

Objective

The purpose of this study was to compare between pain neuroscience education and Kinesio tape on functional outcomes in patients with carpal tunnel syndrome Methods: This study involved 60 patients with carpal tunnel syndrome, consisting of 30 females and 20 males, ranging in age from 20 to 50 years. All participants were allocated into two groups: Group (A) patients with pain neuroscience education, Group (B) patients Kinesio tape

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, Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18 to 60 years.
  • Clinically diagnosed unilateral or bilateral carpal tunnel syndrome based on standard diagnostic criteria (e.g., pain, numbness, or tingling in the median nerve distribution), with or without confirmation by nerve conduction studies.
  • Patients with mild to moderate carpal tunnel syndrome, defined by clinical assessment and electrodiagnostic findings.
  • Symptoms present for at least 3 months.
  • Reported wrist or hand pain with functional limitations affecting daily activities.

排除标准

  • Severe CTS characterised by significant thenar muscle atrophy or severe nerve conduction impairment.
  • Previous Surgery or Injection:
  • History of carpal tunnel release surgery or corticosteroid injection to the wrist within the past 6 months.
  • Presence of other conditions affecting the upper limb, such as cervical radiculopathy, peripheral neuropathy, rheumatoid arthritis, tendon rupture, or fractures.
  • Known neurological disorders (e.g., stroke, multiple sclerosis) or systemic diseases affecting nerve function (e.g., uncontrolled diabetes mellitus).
  • Skin disease, open wounds, or known allergy to adhesive materials that contraindicate kinesio taping.
  • Pregnant women, due to possible changes in fluid retention and nerve compression.
  • Participation in other physical therapy or pain education programmes targeting the upper limbs during the study period.
  • Conditions that limit comprehension of pain neuroscience education material or ability to provide reliable responses to questionnaires.

研究组 & 干预措施

group A: pain neuroscience education (PNE)

Experimental

PNE Components

干预措施: group A: pain neuroscience education (PNE) (Other)

group B: Patients receive Kinesio Taping

Experimental

KT Application Technique

干预措施: group B: Patients receive Kinesio Taping (Other)

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)

时间窗: 8 weeks

self-reported pain intensity scale ranging from 0 (no pain) to 10 (worst imaginable pain), assessing average hand pain over the past week.

Boston Carpal Tunnel Questionnaire

时间窗: 8 months

The BCTQ is a tool that assesses difficulty in performing daily activities of the hand such as writing, gripping and lifting objects It consists of eight items, each scored from 1 (no difficulty) to 5 (unable to perform activity). Higher scores indicate greater functional disability.

Jamar Hand-Held Dynamometer (kg)

时间窗: 8 months

Assess the maximum voluntary grip strength of the affected hand. Three trials are recorded, and the mean value is used for analysis.

次要结局

未报告次要终点

研究者

发起方
Middle East University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emad Eldin Mohamed

associate professor

Middle East University

研究点 (1)

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