跳至主要内容
临床试验/CTRI/2024/10/075664
CTRI/2024/10/075664招募中不适用

A single-center, prospective, observational study to evaluate the effect of acupuncture treatment on lumbar disc pain and functional fitness in patients diagnosed with herniated lumbar disc disease.

Bhaktivedanta Hospital and Research Institute1 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28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Efficacy of Acupuncture Treatment: Measure the reduction in pain and improvement in functional outcomes in patients diagnosed with herniated lumbar disc disease through patient-reported outcomes and clinical assessments.

研究概览

简要总结

This study aims to evaluate the efficacy of acupuncture in treating lumbar disc herniation (LDH), a condition characterized by the displacement of the disc beyond the intervertebral space, often resulting in lower back pain, neurological dysfunction, and associated symptoms. The primary objective is to assess acupuncture’s effectiveness in reducing pain and improving functional outcomes in patients. Secondary objectives include evaluating the need for additional pain management, such as painkillers or nerve blockers, and monitoring changes in key pain and disability metrics using the Numeric Pain Rating Scale (NPRS), Oswestry Low Back Disability Score, Patients’ Global Impression of Change (PGIC) score, and SF-36 score. The study will also track hospital admissions related to LDH during the treatment period. Inclusion criteria include all genders aged ≥18 years, diagnosed with lumbar disc herniation or degeneration confirmed by MRI/X-ray, and with an NPRS score of ≥5. Exclusion criteria include previous spinal surgery, severe spinal deformities, pregnancy, and other serious medical conditions. Data parameters will include MRI findings, NPRS scores, Oswestry Low Back Disability Questionnaire results, PGIC scale, SF-36 Questionnaire results, and a qualitative interview covering functional capabilities like walking, standing, and sitting, as well as the need for additional pain management or hospital admission. A total of 60 patients will be recruited for this study, with primary endpoints focused on acupuncture’s efficacy in reducing pain and improving functional outcomes, and secondary endpoints assessing the need for additional pain management and hospital admissions related to LDH.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All genders, aged ≥ 18 years
  • Diagnosed with lumbar disc herniation or degeneration confirmed by MRI/Xray
  • Lower back NPRS ≥ 5
  • No prior acupuncture treatment in the past 6 months.

排除标准

  • Previous spinal surgery
  • Severe spinal deformities (e.g., scoliosis)
  • Other serious medical conditions (e.g., cancer, severe cardiovascular diseases)
  • Pregnancy
  • Use of other concurrent therapies for back pain (e.g., physiotherapy, chiropractic care).

结局指标

主要结局

Efficacy of Acupuncture Treatment: Measure the reduction in pain and improvement in functional outcomes in patients diagnosed with herniated lumbar disc disease through patient-reported outcomes and clinical assessments.

时间窗: 70 days

次要结局

未报告次要终点

研究者

发起方
Bhaktivedanta Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Komal Dalal

Bhaktivedanta Hospital and Research Institute

研究点 (1)

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