跳至主要内容
临床试验/CTRI/2024/04/065501
CTRI/2024/04/065501尚未招募不适用

To evaluate the clinical outcome of tolperisone and thiocolchicoside in combination with aceclofenac in females with low back pain

VMMC and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年4月20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
70
试验地点
1
主要终点
To assess the clinical outcomes of Tolperisone and Thiocolchicoside used in combination with Aceclofenac on female patients with low back pain using

研究概览

简要总结

Low back pain is defined as pain and discomfort localized below the costal margin and above inferior gluteal folds, with or without radiating to the legs.1 According to WHO, Acute low back pain is an episode that persist for less than 6 weeks and Subacute low back pain is pain between 6 to 12 weeks.2 The Global Burden of Disease Study 2016 reported that low back pain (LBP) contributes 57.6 million years lived with disability (YLD).3 The lifetime prevalence in LBP in India was found to be significantly higher in men, about 65% and 57% with women.4  According to WHO, LBP may be classified as specific and non-specific. Non-specific means that the pain experience cannot be account for another disease and is about 90% of cases. Specific LBP can be explained by an underlying disease (cancer, etc) and tissue damage (fracture, etc) or may referred from other organs (from kidney, aortic aneurysm. etc).2 The spasm-pain-spasm cycle suggest that muscle spasm caused by any injury, can induce pain and reduce range of motion. The feeling of pain can cause further muscle contractions that further increase the intensity of pain, resulting in self-perpetuation of the cycle and chronicity of LBP.5,6 According to a Canadian clinical practice guidelines 2015, the treatment recommended in acute and subacute low back pain are education and reassurance, advice to stay active, therapeutic exercise, heat and cold packs. Analgesia is provided by prescribing acetaminophen, NSAIDs, consider adding short course of muscle relaxant like benzodiazepines, cyclobenzaprine or anti-spasticity drugs as short term. Brief course of opioids can be used if pain is not in control with acetaminophen and NSAIDs.7 According to NICE guidelines, 2016 the pharmacological recommendation for treatment of low back pain consists of oral NSAIDs, paracetamol should not be used alone. Weak opioids with or without paracetamol can be used if NSAIDs is contraindicated.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc

入排标准

年龄范围
18.00 Day(s) 至 45.00 Day(s)(—)
性别
Female

入选标准

  • Female patients with non-specific low back pain of age group 18 years to 45 years with BMI 18.5 to 30 having symptoms for less than 12 weeks.

排除标准

  • Received skeletal muscle relaxant and NSAIDs during past 1 week
  • Patient with rheumatological disorder
  • Recent history of spinal injections in the past 3 months
  • History of vertebral fracture
  • Contraindication of Aceclofenac, Tolperisone and Thiocolchicoside.

结局指标

主要结局

To assess the clinical outcomes of Tolperisone and Thiocolchicoside used in combination with Aceclofenac on female patients with low back pain using

时间窗: Day 0, Day 7, Day 21, Day 42

1. Visual Analogue Scale

时间窗: Day 0, Day 7, Day 21, Day 42

2. Finger to Floor Distance

时间窗: Day 0, Day 7, Day 21, Day 42

3. Oswestry Disability Index

时间窗: Day 0, Day 7, Day 21, Day 42

次要结局

  • To estimate the frequency of relapse and side effect in the study population in 6 weeks of follow up(Day 42)

研究者

发起方
VMMC and Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Daphika Dkhar

VMMC and Safdarjung Hospital

研究点 (1)

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