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临床试验/CTRI/2021/02/031477
CTRI/2021/02/031477招募中2/3 期

Double-blind, randomized, placebo-controlled, feasibility trial of individualizedhomeopathic medicines in sciatica pain

D N De Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年2月24日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
42
试验地点
1
主要终点
The Roland Morris pain and disability questionnaire (RMPDQ)

研究概览

简要总结

Sciatica is a debilitating condition in which the patient experiences pain and/or paresthesia in the distribution of the sciatic nerve or associated lumbo-sacral nerve root. Sciatica is a relatively common condition with a lifetime incidence varying from 13-40%. The different treatment methods are bed rest (trade-off), analgesics or NSAIDS, acupuncture, epidural steroid injections, spinal manipulation, traction therapy, physical therapy, behavioral treatment, surgical intervention etc. with various results. There are number of studies for the treatment of LBP in homeopathy, including the cases of sciatica pain. But, till date, there is no controlled trial of individualized homeopathy in sciatica pain. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 42 patients suffering from sciatica will be randomized to receive either individualized homeopathic medicines (verum; n=21) or identical-looking placebo (control; n=21). We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homeopathic medicines in the treatment of sciatica pain and disability, and to investigate whether there are any differences in outcomes between these two groups over 2 months of intervention. Roland Morris pain and disability questionnaire (RMPDQ), McGill pain questionnaire (MPQ), and Oswestry LBP questionnaire will be used as the primary and secondary outcome measures respectively. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex
  • Age 18-65 years
  • Patients experiencing low back pain radiating to lower limb (unilateral or bilateral) since 3 months or more (2018/19 ICD-10-CM diagnosis code M54.31); confirmed by straight leg raising test.
  • Patients who are literate and capable of filling the questionnaire and providing informed consent.

排除标准

  • Patients suffering from uncontrolled systemic diseases or infections; e.g. diabetes mellitus, cardiovascular diseases, thyroid diseases, etc.
  • Patients having history of surgery to the lower back
  • Patients suffering from disc prolapse, psoriatic arthritis and gout, cases willing for or requiring immediate surgical intervention or already underwent any major spinal or hip surgery in last 6 months.
  • Patients who are undergoing treatment with NSAIDS during 6 weeks prior to enrolment in the study
  • Spinal corticosteroid injection within 6 months
  • Pregnant, lactating and puerperial women
  • Self-reported immune-compromised state
  • Substance abuse and/or dependence.

结局指标

主要结局

The Roland Morris pain and disability questionnaire (RMPDQ)

时间窗: At baseline and after 2 months

次要结局

  • Oswestry LBP questionnaire(At baseline and after 2 months)
  • McGill pain questionnaire (MPQ)(At baseline and after 2 months)

研究者

发起方
D N De Homoeopathic Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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