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临床试验/NCT06850779
NCT06850779已完成不适用

Effects of Radial Extracorporeal Shock Wave and Kinesio Taping Treatments on Quality of Life, Hand Function and Median Nerve Cross-Sectional Area Measured by Ultrasonography in Patients with Carpal Tunnel Syndrome: a Single-Blind Randomized Controlled Trial

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
Pain level before treatment, 3rd week and 6th week after treatment

研究概览

简要总结

Carpal Tunnel Syndrome (CTS) is a common upper extremity nerve compression syndrome that causes significant economic and social burden to affected individuals. Although the severity may vary among patients, symptoms such as night pain, transient numbness, tingling, constant pain, muscle weakness, and sleep disturbance may be observed. The treatment of CTS can be grouped as nonsurgical and surgical treatments. The aim of this study is to investigate the effects of treatment with sound waves and a healing method called extracorporeal shock wave therapy and a therapeutic flexible tape called kinesiology taping on pain, grip strength, quality of life, depression symptoms, hand functions, and ultrasonographic median nerve cross-sectional area in patients with CTS.

详细描述

Carpal tunnel syndrome is the most common nerve entrapment syndrome, typically affecting the dominant extremity. Symptoms often become more pronounced at night, and may include numbness, tingling, electric shock sensations, pain, and other related symptoms. Diagnosis can be made based on patient history, physical examination, electrodiagnostic tests, and ultrasonography. Treatment options include splinting, exercise therapy, physical therapy modalities, various injections, and surgical methods.

In our study, we compared the effects of extracorporeal shock wave therapy (ESWT) and kinesiology taping (KT) on carpal tunnel syndrome. The study involved four randomized groups: Group 1 received both ESWT and KT, Group 2 received only ESWT, Group 3 received only KT, and Group 4 received exercise therapy alone. Evaluations were conducted using the Visual Analog Scale, Boston Carpal Tunnel Questionnaire, Douleur Neuropathique 4 Questions, Nottingham Health Profile, grip strength measurements, and median nerve cross-sectional area via ultrasonography. Evaluations were performed three times: before treatment, at week 3, and at week 6.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Mild to moderate unilateral carpal tunnel syndrome confirmed by electroneuromyography (ENMG)
  • •Patients over 18 years of age
  • •Symptom duration of at least 3 months
  • •Those who have not received any medical treatment other than analgesics in the last 3 months

排除标准

  • •Bilateral Carpal Tunnel Syndrome (CTS)
  • •Severe CTS detected by ENMG
  • •Operated CTS
  • •Corticosteroid injection within the last 3 months
  • •History of peripheral nerve damage
  • •Secondary CTS causes (thyroid dysfunction, connective tissue diseases)
  • •Cervical disc herniation
  • •DeQuervain tenosynovitis, trigger finger, Dupuytren contracture
  • •Inflammatory disorder
  • •Bleeding disorder
  • •Pregnancy
  • •Malignancy

研究组 & 干预措施

Group 3

Active Comparator

Those who received KT

干预措施: Kinesio taping (KT) (Other)

Group 3

Active Comparator

Those who received KT

干预措施: Exercise (Other)

Group 4

Other

Those who received only exercise

干预措施: Exercise (Other)

Group 1

Active Comparator

Those who received both extracorporeal shock wave therapy (ESWT) and kinesio taping (KB)

干预措施: Extracorporeal shock wave therapy (ESWT) (Other)

Group 1

Active Comparator

Those who received both extracorporeal shock wave therapy (ESWT) and kinesio taping (KB)

干预措施: Kinesio taping (KT) (Other)

Group 1

Active Comparator

Those who received both extracorporeal shock wave therapy (ESWT) and kinesio taping (KB)

干预措施: Exercise (Other)

Group 2

Active Comparator

Those who received ESWT

干预措施: Extracorporeal shock wave therapy (ESWT) (Other)

Group 2

Active Comparator

Those who received ESWT

干预措施: Exercise (Other)

结局指标

主要结局

Pain level before treatment, 3rd week and 6th week after treatment

时间窗: From enrollment to the end of treatment at 3rd week and 6th week

Pain level will be evaluated with the Visual Analog Scale. (minimum: 0, maximum: 100 mm)

Assessment of symptom severity and functionality

时间窗: From enrollment to the end of treatment at 3rd week and 6th week

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) questionnaire was used to assess symptom severity and functionality. It includes 2 subgroups: Symptom Severity Scale (SSS) and Functional Status Scale (FSS). Symptom severity is assessed with 11 questions, and functional status is assessed with 8 questions. Each question is scored from low to high, 1 to 5. As the total score increases, deterioration increases.

Assessment of median nerve cross sectional area by ultrasonography

时间窗: From enrollment to the end of treatment at 3rd week and 6th week

The median nerve cross-sectional area was measured by tracing just proximal to the carpal tunnel entrance with the wrist resting on a table in a neutral position. The carpal tunnel entrance was identified by detecting the proximal side of the transverse carpal ligament. The distal radioulnar joint was also observed at this level.

次要结局

  • Assessment of grip strength and lateral pinch strength(From enrollment to the end of treatment at 3rd week and 6th week)
  • Assessment of functionality(From enrollment to the end of treatment at 3rd week and 6th week)
  • Assessment of neuropathic pain(From enrollment to the end of treatment at 3rd week and 6th week)
  • Assessment of depression(From enrollment to the end of treatment at 3rd week and 6th week)
  • Assessment of quality of life(From enrollment to the end of treatment at 3rd week and 6th week)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selda Çiftci

Medical doctor

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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