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临床试验/NCT06649461
NCT06649461Enrolling By Invitation不适用

Splint with Ozone Injection for Mild and Moderate Carpal Tunnel: an Electrodiagnostic Study

Selcuk University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
34
试验地点
1
主要终点
Boston Carpal Tunnel Syndrome Questionnaire

研究概览

简要总结

This study will investigate the effectiveness of repeated ozone therapy combined with splint therapy for carpal tunnel syndrome (CTS).CTS patients will be split into two groups: ozone plus splint and splint only. Both groups will use wrist splints for 3 weeks, with the ozone+splint group receiving weekly ozone injections for three weeks.

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 (Investigator)

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

  • being 18-65 years, with mil-modarete CTS, symptoms continued for at least 3 months

排除标准

  • hand edema or prior injections, thenar atrophy, prior CTS surgery, severe EMG results, recent physical therapy, steroids, or platelet-rich plasma for CTS in the past year, and conditions causing secondary CTS (e.g., thyroid disorders, diabetes, pregnancy, rheumatoid arthritis, Dupuytren's contracture, inflammatory arthritis, connective tissue diseases). Also excluded: neck or arm pain conditions (e.g., cervical disc herniation, wrist fracture, proximal upper extremity entrapment neuropathy, polyneuropathy, peripheral nerve damage, fibromyalgia), history of G6PD deficiency, uncontrolled hyperthyroidism, thrombocytopenia, and contraindications to general ozone therapy (e.g., ACE inhibitors for severe cardiovascular instability).

结局指标

主要结局

Boston Carpal Tunnel Syndrome Questionnaire

时间窗: 10 minutes

As the score obtained from the survey increases, the improvement increases.

visual analog scale

时间窗: 1 minute

As the score approaches 10, the intensity of pain felt increases.

electromyography (EMG)

时间窗: 10 minutes

In the electrophysiological examination, median sensory nerve conduction studies and median motor nerve conduction studies will be measured. Median motor nerve latency, median motor nerve conduction velocity, and compound muscle action potential amplitude will be measured and recorded.

次要结局

未报告次要终点

研究者

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

Emine Cihan

Assist. Prof. Dr.

Selcuk University

研究点 (1)

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