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临床试验/CTRI/2025/02/080004
CTRI/2025/02/080004尚未招募3 期

Efficacy of single dose of perineural prolotherapy and corticosteroid injections in primary Carpal Tunnel Syndrome at a tertiary care hospital in India - A randomized control trial

All India Institute of Medical Sciences Bhubaneswar Odisha1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年2月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
1.To measure pain relief following perineural injections of dextrose prolotherapy and corticosteroid in Carpal Tunnel Syndrome.

研究概览

简要总结

We aim to investigate the effectiveness of dextrose prolotherapy compared to corticosteroid injection in reducing pain and improving function in patients with Carpal Tunnel Syndrome. We hypothesize that dextrose prolotherapy injection will be superior to corticosteroid injection in terms of pain relief and functional improvement. This study has the potential to provide valuable insights into the use of regenerative injections in Carpal Tunnel Syndrome management and contribute to better outcomes for patients.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients aged above 18 years 2.Patients with Nocturnal paresthesia, symptomatically getting relief after shaking the hands.
  • 3.Pain, paresthesia or sensory symptoms in the area of the median nerve over the thumb and finger.
  • 4.Symptoms longer than 4 weeks duration.
  • 5.Numbness in sensory distribution of median nerve.
  • 6.Weakness with atrophic change of median nerve innervated thenar muscles.
  • 7.Phalen test +, and or Tinel Sign +.

排除标准

  • 1.Pregnancy 2.H/O of polyneuropathy, brachial plexopathy, thoracic outlet syndrome.
  • 3.H/O Inflammatory arthritis, Type 2 DM, Rheumatologic disorder.
  • 4.Previous h/o CS Injection, Skin infection on injection site, trauma or neoplasm at injection site, hypersensitivity to corticosteroid.
  • 5.Current warfarin use.

结局指标

主要结局

1.To measure pain relief following perineural injections of dextrose prolotherapy and corticosteroid in Carpal Tunnel Syndrome.

时间窗: 1. 0 weeks (V0) | 2. 6 weeks (V1) | 3. 12 weeks (V2)

次要结局

  • 1.To measure functional improvement following perineural injections of dextrose prolotherapy and corticosteroid in Carpal Tunnel Syndrome.(2 years)
  • To measure the change in quality of life following perineural injections of dextrose prolotherapy and corticosteroid in Carpal Tunnel Syndrome.(2 years)

研究者

发起方
All India Institute of Medical Sciences Bhubaneswar Odisha
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Lakshmi Sajith

AIIMS Bhubaneswar

研究点 (1)

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