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临床试验/NCT06360510
NCT06360510已完成不适用

Comparison of the Effectiveness of Ultrasound-guided 5% Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome.

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月5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
30
试验地点
1
主要终点
Numeric rating scale - 10

研究概览

简要总结

The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS).

详细描述

It is planned as an observational, single-center clinical study.A total of 28 patients diagnosed with mild-moderate carpal tunnel syndrome who meet the inclusion criteria will be included in the study.Patients who had been experiencing trigger finger symptoms for at least three month and who presented to the Gaziler Physical Medicine and Rehabilitation Training and Research Hospital, affiliated with the Health Sciences University Faculty of Medicine.

Patients will be divided into two groups. One group will receive 5% dextrose, the other group will receive 1 session of local injection by mixing Celeston chronodose [1ml/3 mg betamethasone acetate+3,947 mg betamethasone disodium phosphate (equivalent to 3 mg betamethasone)] and 1 ml 2% prilocaine.

Evaluations will be made before injection, at weeks 4 and 12.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Paresthesia and pain symptoms in the region corresponding to the distribution of the median nerve
  • Detection of mild or moderate CTS by electromyography
  • One or both of the Phalen test and/or Tinel sign are positive on physical examination
  • Symptoms have persisted for at least 3 months

排除标准

  • Those diagnosed with polyneuropathy, plexopathy, radiculopathy, thoracic outlet syndrome
  • Having had surgery or any injection for carpal tunnel syndrome within the last year
  • History of wrist fracture
  • Those with rheumatoid arthritis, uncontrolled diabetes, gout, chronic renal failure, malignancy, active systemic infection
  • Those with cognitive impairment
  • Coagulopathy or bleeding tendency
  • Pregnancy

研究组 & 干预措施

%5 dextrose group

干预措施: %5 dextrose injection (Procedure)

betamethasone group

干预措施: betamethasone injection (Procedure)

结局指标

主要结局

Numeric rating scale - 10

时间窗: three months

The Numeric Rating Scale (NRS) is a simple and widely used tool for assessing pain intensity. Patients are asked to rate their pain on a scale from 0 to 10, where: 0 = No pain 1-3 = Mild pain 4-6 = Moderate pain 7-9 = Severe pain 10 = Worst pain imaginable The patient selects the number that best represents their pain at last one week

次要结局

  • median nerve cross sectional area(three months)
  • boston carpal tunnel syndrome questionnaire(three months)
  • tinnel test positivity(three months)
  • phalen test positivity(three months)
  • DuruÖz hand index(three months)

研究者

发起方
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasin Demir

Clinical Professor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

研究点 (1)

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