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临床试验/CTRI/2024/09/073211
CTRI/2024/09/073211尚未招募不适用

Prospective evaluation of pain relief and dynamic mobility of median nerve, using ultrasound following corticosteroid injection and carpal tunnel release in patients with carpal tunnel syndrome.

Dr RMLIMS1 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3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Assessment of Improvement in the Pain levels of the patient undergoing the two interventions by VAS Score and BCTQ Scale.

研究概览

简要总结

Carpal tunnel syndrome is the most common peripheral nerve entrapment syndrome worldwide. The clinical symptoms and physical examination findings in patients with this syndrome are recognised widely, and various treatments exist, including non-surgical and surgical options. Damage to the median nerve within the carpal tunnel gives rise to carpal tunnel syndrome (CTS), associated with a broad spectrum of symptoms In this era of evidence-based medicine, randomized controlled clinical trials (RCTs) are highly valued because known and unknown confounding variables will be randomly distributed between the two types of  interventional therapies used in the treatment of Carpal Tunnel, that is, local and non-invasive corticosteroid therapy based versus surgical.

This study aims at determining the efficacy of the two therapies and there long term effects with respect to both, pain relief as well as median nerve parameters on Ultrasonographic examination.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Clinical diagnosis of Carpal Tunnel Syndrome, with duration more than six months not responding to conservative measures including non-steroidal anti-inflammatory drugs (NSAIDS),.
  • Patient willing to participate in the study after proper Informed Consent taking.

排除标准

  • Earlier surgery like Ultrasound Guided Carpal Tunnel Release or Open Carpal Tunnel Release,.
  • Local Corticosteroid injection within the last 6 months,.
  • Patients who have received Platelet Rich Plasma Therapy for Carpal Tunnel Syndrome.
  • Physical therapy within 6 weeks, image proved rupture or conditions in which non-steroidal anti-inflammatory drugs were used within 1 week,.
  • History of severe anemia (Hemoglobin less than 5),.
  • Thrombocytopenia or Bleeding tendency,.
  • Vascular insufficiency (Impalpable Radial Pulse).
  • Neuropathy which is related to pain.

结局指标

主要结局

Assessment of Improvement in the Pain levels of the patient undergoing the two interventions by VAS Score and BCTQ Scale.

时间窗: 1. Before procedure | 2. Right after procedure | 3. 1 week | 4. 1 month | 5. 3 months | 6. 6 months

次要结局

  • Median nerve crosssectional area and mobility using ultrasonographic measurement.(Ultrasonographic assessment pre and post intervention at different time intervals up to 6 months.)

研究者

发起方
Dr RMLIMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Shivani Rastogi

Dr RMLIMS

研究点 (1)

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