跳至主要内容
临床试验/CTRI/2025/10/096322
CTRI/2025/10/096322尚未招募不适用

Comparison of Integrated Approach of Yoga Therapy (IAYT) versus Usual Care in Management of Chronic Low Back Pain Using Quantitative Sensory Testing

Central Council For Research In Yoga And Naturopathy1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年11月1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
82
试验地点
1
主要终点
To evaluate changes in the Verbal Numeric Rating Scale (NRS) and Quantitative Sensory Testing (QST) parameters Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) in patients with CLBP

研究概览

简要总结

This prospective, Randomized ,parallel group clinical trial will compare the effectiveness of the Intergrated Approach of Yoga Therapy (IAYT) versus usual care in patients with chronic non- specific low back pain. A total of 82 adult participants with low back pain for more than three months and a pain score of (NRS) more than 5 will be randomized in a 1:1 ratio to either receive IAYT or usual care. The IAYT group will undergo 60 minute yoga sessions over 2 weeks including physical, postures, breathing exercises, and meditation, followed by Home practice. The usual care group will receive standard advice on ergonomics, posture, physical activity, and a back care booklet. Participants will be assessed at baseline, four weeks and at 12 weeks for pain intensity (NRS) , disability (modified oswestry, disability index), quality of life (EQ – 5D), and quantitative sensory testing parameters (pressure, pain threshold, and conditioned pain modulation). The primary aim is to estimate the difference in pain, intensity, and sensory testing parameters between groups and to demonstrate the effectiveness of yoga as an adjunct in managing chronic low back pain. The study will be conducted at the pain clinic, department of anaesthesia and intensive care, PGIMER, Chandigarh from January 2025 to June 2026.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator 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

  • History of non-specific low back pain (LBP) with symptoms persisting for more than three months Failure to respond to conservative management Numerical Rating Scale (NRS) score of greater than or equal to 5 at the time of enrolment Age grater than 18 years Ambulatory and naïve to yoga.

排除标准

  • LBP caused by nerve root compression, disc prolapse, spinal stenosis, tumor, spinal infection, ankylosing spondylitis, spondylolisthesis, kyphosis, structural scoliosis, or widespread neurological disorders Pre-surgical candidates Compromised cardiopulmonary system Pregnancy Body mass index (BMI) greater than 35 Individuals experiencing major depression or substance abuse Participants who are unable to communicate in either Hindi or English.

结局指标

主要结局

To evaluate changes in the Verbal Numeric Rating Scale (NRS) and Quantitative Sensory Testing (QST) parameters Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) in patients with CLBP

时间窗: at baseline, 4 weeks, 12 weeks

次要结局

  • 1) To study the changes in the results of the Modified Oswestry Low Back Pain Disability Index (MODI) & EuroQOL (EQ-5D) in patients with CLBP at baseline(at baseline, 4 weeks, 12 weeks)

研究者

发起方
Central Council For Research In Yoga And Naturopathy
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

NIKHIL MANUKONDA

tion Post Graduate Institute of Medical Research

研究点 (1)

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