Effectiveness of Integrated Approach of Yoga Therapy (IAYT) versus usual care in management on Chronic Low Back Pain Patients: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Functional Disability measured using Modified Oswestry Disability Index (MODI)
研究概览
简要总结
A randomized controlled trial has been planned to evaluate whether Integrated Approach of Yoga Therapy (IAYT), is more effective thanthe usual care. Patients from 18 to 65 years osage, with a history of low back pain for more than 3 months will be recruited
A series of 60 minutes Integrated approach of Yoga therapy (IAYT) class (for a span of 15 days), using all of the components of yoga at the body, subtle energy, and mind level, respectively will be conducted. They will be asked to practice the techniques at home discussed in each session daily for up to 45 minutes, throughout the intervention period, and after classes end. Various methods will be used for participants adherence and encouragement such as WhatsApp group for encouragements at regular intervals. Also WhatsApp photo/video updates, Yoga pamphlet on the guidelines of practise, A video CD will also be etc. They will be following a similar practise routine for next span of intervention.
ASSESSMENT TOOLS
ASSESSMENT FOR PAIN MEASURES
Numeric rating scale (NRS)
ASSESSMENT FOR DISABILITY INDEX
Modified Oswestry Disability Index (MODI)
PAIN ASSESSMENT
Douleur Neuropathie 4 (DN4)
Pain Catastrophizing Scale (PCS)
ASSESSMENT FOR HEALTH RELATED QUALITY OF LIFE
EuroQol (EQ-5D- 5L)
ASSESSMENT FOR MENTAL HEALTH
Hospital Anxiety and Depression Scale (HADS)
ASSESSMENT FOR FEAR OF MOVEMENT
The Tampa Scale of Kinesiophobia (TSK)
ASSESSMENT FOR CLINICAL BENEFIT FROM THE TREATMENT
Patient Global Impression of Change scale (PGIC)
Medication assessment
ASSESSMENT USING PAIN BIOMARKERS
B endorphins
TNFalpha
CGRP
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults indicative of low back pain with or without leg pain for more than 3 months, Average pain intensity of ≥ 4 on a Numeric Rating scale (NRS), Participants who are willing to participate, Who are ready to travel and attend yoga classes, and are willing to continue home practise.
排除标准
- •Pain due to organic causes such as infective and inflammatory conditions, or degenerative disorders of the muscles.
- •Critically ill and is unable to participate due to severe pain.
- •Patients diagnosed with fixed lumbar spinal canal stenosis or sacroiliac joint dysfunction.
- •Severe Obesity -Chronic pain occurred due to cancer or involvement of fibromyalgia, diabetic neuropathy and other systematic complications such as cardiac, kidney disorders.
- •Patients who have undergone lower back region surgery.
- •Patients with pre-existing psychiatric illness.
结局指标
主要结局
Functional Disability measured using Modified Oswestry Disability Index (MODI)
时间窗: At 3 monts
次要结局
- Pain assessed using VNRS, DN4 and PCS, mental Health using HADS, Quality of Life using EuroQol and measure fear of movement i.e. Kinesiophobia using TAMPA Scale and patient global impression clinical improvement to measure of the overall clinical benefit from the treatment. Potential Pain Biomarkers using blood serum β – Endorphins, TNF – α and salivary assessment of CGRF will help us derive the effects of IAYT regime on pain and these biomarkers themselves(Baseline. 15 days, one month and 3 months all except pain biomarkers which will be assessed at baseline 1 month and 3 months)