跳至主要内容
临床试验/NCT06554405
NCT06554405已完成不适用

Examining the Effects of Bilateral Neuromobilization in Patients With Carpal Tunnel Syndrome: Comparison Study With Unilateral Application

Gazi University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Symptom Severity Assessment (Boston Carpal Tunnel Syndrome Questionnaire- Symptom Severity Scale)

研究概览

简要总结

This study aims to investigate whether bilateral (both extremities together) neuromobilization is superior to unilateral (only the affected side) neuromobilization in individuals diagnosed with Carpal Tunnel Syndrome.

详细描述

Carpal Tunnel Syndrome (CTS) is defined as an upper extremity nerve entrapment resulting from the compression of the median nerve at the wrist level. It is the most common entrapment neuropathy. Patients with CTS experience numbness, tingling, and pain in the hand, which can sometimes extend to the arm, along with hand weakness and thenar atrophy. These symptoms typically worsen after hand use and at night. While clinical findings are absent in the early stages of the disease, sensory and strength loss is observed in the areas innervated by the median nerve in advanced stages.

The pathophysiology of CTS includes hypertrophic changes in the synovial tissue of the flexor tendon, connective tissue changes in the median nerve, conduction disturbances, and increased pressure in the carpal tunnel.

Treatment is tailored to the patient's symptoms. Conservative treatment is preferred in mild to moderate stages, while surgical intervention may be necessary in advanced stages. All patients should receive education on ergonomics aimed at reducing symptoms in daily life.

Conservative treatment for CTS includes nerve mobilization techniques, the use of orthoses to maintain the wrist in a neutral position, electrotherapy (ESWT, laser), manual therapy, kinesiotaping, corticosteroid and platelet-rich plasma (PRP) injections, and anti-inflammatory medications. Patients who do not respond to conservative treatment are referred for surgery.

Neural structures are capable of tolerating significant tension and compression forces encountered during daily activities and sports. This capability is due to the connective tissue sheath surrounding the nerve.

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

The researcher who will evaluate the patients before and after treatment will not know which group the patients are in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals diagnosed with CTS,
  • Aged 18 and above,
  • Without any other conditions in either upper extremity (such as trigger finger, osteoarthritis, tenosynovitis)

排除标准

  • Individuals with a history of surgery, trauma, or fracture in the same upper extremity,
  • Those who have received an injection for CTS in the last 3 months,
  • Those with poor cooperation,
  • Those participating in any other treatment program during the study,
  • Those with a history of uncontrolled systemic diseases or systemic diseases involved in the etiology of CTS (such as diabetes, thyroid diseases, rheumatoid arthritis),
  • Those who have used orthoses regularly and/or received physiotherapy in the last 3 months,
  • Individuals with marked thenar atrophy requiring early surgical intervention

结局指标

主要结局

Symptom Severity Assessment (Boston Carpal Tunnel Syndrome Questionnaire- Symptom Severity Scale)

时间窗: Four weeks

The Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), developed in 1993, will be used to assess individuals' functional status and symptoms. The Turkish validity and reliability study of the test has been conducted. The test consists of two self-assessment sections: one with 11 questions evaluating symptom severity and another with 8 questions evaluating functional capacity. It is a Likert-type questionnaire, where 1 indicates the best condition and 5 indicates the worst condition. The total score is calculated by dividing the total points by the number of questions, resulting in a score between 1 and 5.

次要结局

  • Light Touch and Pressure Sense(Four weeks)
  • Gross Grip Strength(Four weeks)
  • Pinch Grip Strength(Four weeks)
  • Light Touch and Pressure Sense(Four weeks)
  • Visual Analog Scale (VAS)(Four weeks)
  • Gross Grip Strength(Four weeks)
  • Pinch Grip Strength(Four weeks)
  • Functional Level Assessment (Boston Carpal Tunnel Syndrome Questionnaire-Functional Status Scale)(Four weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Öznur Güney

Research Assistant

Gazi University

研究点 (1)

Loading locations...

相似试验