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临床试验/NCT06405438
NCT06405438招募中不适用

Comparison of the Efficacy of Peloid Therapy and Paraffin Treatment in Carpal Tunnel Syndrome

Beylikduzu State Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10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
60
试验地点
1
主要终点
Boston Carpal Tunnel Syndrome Questionnaire

研究概览

简要总结

This study compares the effectiveness of peloid therapy and paraffin treatment in carpal tunnel syndrome. Patients who have already received 2 weeks of peloid therapy or 15 sessions of paraffin treatment will be assessed. Pain and symptom severity are assessed using the Visual Analog Scale (VAS) and Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Electrophysiological examinations will also be conducted at the same time points: baseline, 4 weeks post-treatment, and a 12-week follow-up.

详细描述

Our study will include 60 patients aged 18-65 who visited the outpatient clinics of Beylikdüzü State Hospital between January 1, 2024, and September 1, 2024, and were diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological examinations. These patients received either peloid or paraffin treatment. Patients with symptoms persisting for a minimum of 3 months will be included in the study. In this study, pain levels will be evaluated using the Visual Analog Scale (VAS), and the type and severity of symptoms will be assessed with the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). At our hospital, the standard paraffin treatment consists of 15 sessions, administered 5 days per week, while the peloid therapy consists of 10 sessions, also administered 5 days per week. The VAS, BCTQ scores, and electrophysiological evaluations of the patients will be assessed at the 4th and 12th weeks post-treatment. Electrophysiological parameters including 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) will be recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

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 between 18 and 65 years old.
  • Patients diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological evaluations.
  • Patients experiencing symptoms for a minimum of 3 months.

排除标准

  • Patients diagnosed with neuropathic conditions such as polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
  • Patients with a history of previous injections or surgery for carpal tunnel syndrome.

结局指标

主要结局

Boston Carpal Tunnel Syndrome Questionnaire

时间窗: 0 day, 4th week and 12th week

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) consists of two parts: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). Both parts are scored on a 5-point Likert scale, with higher scores indicating worse symptoms or functional impairment.The highest possible total score for the Symptom Severity Scale is 55, which reflects the most severe symptoms.The highest possible total score for the Functional Status Scale is 40, indicating the greatest functional impairment.The minimum total score is 19 (indicating minimal or no symptoms and functional limitations). The maximum total score is 95 (indicating the most severe symptoms and functional limitations). As the total score increases, the severity of symptoms and functional limitations worsens, meaning higher scores reflect worse outcomes.

次要结局

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