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临床试验/NCT06658886
NCT06658886招募中不适用

Comparison of the Efficacy of Ultrasound-Guided Corticosteroid Injection and Paraffin Therapy in Carpal Tunnel Syndrome

Beylikduzu State Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
46
试验地点
1
主要终点
Visual Analog Scale (VAS):

研究概览

简要总结

The aim of this study is to compare the efficacy of paraffin therapy, a physical therapy modality, and ultrasound-guided corticosteroid injection in the treatment of carpal tunnel syndrome, the most common entrapment neuropathy. By doing so, the study will evaluate the effectiveness and feasibility of these two alternative, low-side-effect treatments for managing this frequently encountered condition.

详细描述

A total of 46 patients, aged 18-65, diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies, will be included in the study.Pain levels will be assessed using the Visual Analog Scale (VAS), and functional impairment will be measured with the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Electrophysiological evaluations will be performed by a neurology specialist at the 1st and 3rd month follow-ups outside of working hours and without being billed to the Social Security Institution (SGK). VAS, BCTQ scores, and electrophysiological parameters will be evaluated at baseline, and at the 4th and 12th-week follow-ups post-treatment. Electrophysiological measurements will include median nerve distal motor latency (MMNDL), median nerve distal sensory latency (MNSDL), sensory nerve conduction velocity (SNCV), compound muscle action potential (CMAP), and sensory nerve action potential (SNAP) amplitudes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

入选标准

  • Patients aged 18-
  • Diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies.
  • Received either ultrasound-guided corticosteroid injection or paraffin therapy.
  • Symptoms persisting for at least 3 months.

排除标准

  • Diagnosis of other conditions causing neuropathic symptoms (e.g., polyneuropathy, brachial plexopathy, thoracic outlet syndrome).
  • History of previous injection or surgery for carpal tunnel syndrome.

结局指标

主要结局

Visual Analog Scale (VAS):

时间窗: 0 day, 4th week and 12th week

The VAS will be used to measure pain intensity. Patients will mark their pain level on a 10 cm scale, where 0 represents "no pain" and 10 represents the "worst imaginable pain." This will be evaluated at baseline, and at the 4th and 12th weeks post-treatment.

Boston Carpal Tunnel Syndrome Questionnaire Symptom Severity Scale (BCTQ-SSS)

时间窗: 0 day, 4th week and 12th week

The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.

Boston Carpal Tunnel Syndrome Questionnaire Functional Status Scale (BCTQ-FSS)

时间窗: 0 day, 4th week and 12th week

The SSS assesses the severity of carpal tunnel symptoms such as pain, tingling, and numbness. The total score for this scale ranges from a minimum of 11 to a maximum of 55. A lower score indicates mild or no symptoms, while a higher score suggests more severe symptoms. As the score increases, the severity of symptoms worsens, with a score closer to 55 reflecting a significantly greater impact on daily life.

次要结局

  • Median nerve distal motor latency(0 day, 4th week and 12th week)
  • Motor nerve conduction velocity(0 day, 4th week and 12th week)
  • Motor nerve action potential amplitude(0 day, 4th week and 12th week)
  • Median nerve distal sensory latency(0 day, 4th week and 12th week)
  • Sensory nerve conduction velocity(0 day, 4th week and 12th week)
  • Sensory nerve action potential amplitude(0 day, 4th week and 12th week)

研究者

发起方
Beylikduzu State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Busra Sirin

Principle Investigator

Beylikduzu State Hospital

研究点 (1)

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