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临床试验/NCT06469931
NCT06469931招募中不适用

Comparison of the Effectiveness of ESWT and Ozone Therapy in Patients With Carpal Tunnel Syndrome

Firat University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Median nerve cross-sectional area

研究概览

简要总结

ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting.

详细描述

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy resulting from compression of the median nerve at the wrist level. Various methods are applied in the conservative treatment of CTS. These include modification of daily life, splinting, physical therapy modalities and exercise methods. ESWT (Extracorporeal Shock Wave Therapy), which has been used in the treatment of musculoskeletal diseases in recent years, has come to the agenda as a new treatment method in Carpal Tunnel Syndrome. Ozone therapy has trophic effects, analgesic effects, antioxidant, immunomodulator, anti-inflammatory and antitumoral effects. Although the effectiveness of ESWT, splinting and exercise applications in CTS patients is known in the literature, studies on the effectiveness of ozone therapy are limited. The aim of this study was to compare the efficacy of ozone therapy and ESWT applied in addition to splinting and exercise applications in patients diagnosed with CTS. The study will consist of 2 groups. In addition to exercise and splinting, 3 sessions of ozone therapy will be applied once a week to study group.Patients in the control group will receive ESWT once a week for 3 consecutive weeks in addition to exercise and splinting. Ultrasonographic examinations of the median nerve cross-sectional area will be performed using a LOGIQ P5 (Healthcare Ultrasound, Korea) and a high frequency 7-12 MHz linear probe. A hand dynamometer will be used to assess the grip strength of the hand.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients between the ages of 18-65 who have been complaining for at least 3 months
  • •Diagnosed with mild or moderate Carpal Tunnel Syndrome

排除标准

  • •Cervical disc herniation or radiculopathy,
  • •Brachial plexus lesion
  • •Previous hand or neck surgery
  • •Pregnancy,
  • •History of fracture at the wrist level
  • •Inflammatory rheumatic disease

研究组 & 干预措施

Ozone therapy group

Experimental

In addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week.

干预措施: range of motion exercises (Other)

Extracorporeal shock wave therapy group

Experimental

Patients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercisess for wrist and hand and splinting.

干预措施: range of motion exercises (Other)

Extracorporeal shock wave therapy group

Experimental

Patients in this group will receive ESWT once a week for 3 consecutive weeks in addition to range of motion exercisess for wrist and hand and splinting.

干预措施: Extracorporeal shock wave therapy (Device)

Ozone therapy group

Experimental

In addition to range of motion exercises for wrist and hand and splinting, 3 sessions of ozone therapy will be applied once a week.

干预措施: ozone therapy (Other)

结局指标

主要结局

Median nerve cross-sectional area

时间窗: 2 minutes

Patients will be positioned seated facing the assessor, with the volar aspect of the wrist facing the air and at rest on a pillow. In the proximal carpal tunnel (at the level of the pisiform bone), the median nerve hyperechoic inner border line will be continuously traced and the transverse section surface area will be measured.

次要结局

  • Pain assesment(1 minute)

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Songül Bağlan Yentür

Head of Physiotherapy and Rehabilitation Department

Firat University

研究点 (1)

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