Comparison of Yoga and Dynamic Neuromuscular Stabilization Exercise in Chronic Low Back Pain on Magnetic Resonance Imaging of Lumbar Multifidus- A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Magnetic resonance imaging (MRI)
研究概览
简要总结
The lifetime prevalence of low back pain is reported to be as high as 84%, and the prevalence of chronic low back pain is about 23%, with 11–12% of the population being disabled by low back pain. Yoga is a traditional mind-body system originating in India over 4000 years ago. The goal of yoga, a Sanskrit term meaning “yoke or union†do not centre primality on physical, but rather on integration of mind, body and spirit, cultivation of balance, calm, harmony and awareness.
Cochrane review on yoga for chronic low back pain has concluded, it is uncertain whether there is any difference between yoga and other exercise for back-related function or pain. Recent study has validated integrated yoga module comprising yoga postures and breathing for chronic low back pain, however scientific evidence of effect of yoga on pathology of low back pain is lacking. Lumbar muscle degeneration is characterized by a decrease in cross-sectional area (CSA) and an increase in the amount of fat content of the lumbar paraspinal muscles. According to the recent studies, the patients with chronic low back pain have Thoraco lumbar Fascia (TLF) thickened by 25% or more measured through Ultrasound imaging. No study could be retrieved on the effects of yoga on cross sectional area of lumbar multifidus with magnetic resonance imaging and thoracolumbar fascia using Ultrasound imaging in chronic low back pain.
Patients diagnosed with chronic low back pain will be allocated randomly in two groups: yoga and dynamic muscular stabilisation group. Both the groups will undergo training under supervision for 3-5 days/week for 12 weeks. Baseline data will be collected followed by recording of primary outcome measures (Magnetic Resonance Imaging) and secondary outcome measures (Ultrasound Imaging, Oswestry Disability index, Visual Analogue Score, Optimism, self-efficacy, mood, physical activity, fear of movement, pain catastrophizing and coping) at baseline, after 12 weeks. Data will be collected and analyzed.
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed with chronic low back pain (duration more than 12 weeks).
排除标准
- •1.Inflammatory pathology of the lumbar spine 2.Lumbar radiculopathy 3.Subjects who have recent spinal fracture or surgery 4.Have lumbar pain of traumatic origin 5.If they are current or past smokers or tobacco chewers 6.Have participated in a yoga or lumbar exercise program in the past 3 months
- •Pain Score VAS more than 4.
结局指标
主要结局
Magnetic resonance imaging (MRI)
时间窗: At baseline (0 week) and at end of 12th week
次要结局
- Ultrasound Imaging (RUSI)(At baseline (0 week) and at end of 12th week)
- Visual analogue scale (VAS)(At baseline (0 week) and at end of 12th week)
- Oswestry Disability Index (ODI)(At baseline (0 week) and at end of 12th week)
- The Life Orientation Test (LOT)(At baseline (0 week) and at end of 12th week)
- Patient-Reported Outcomes Measurement Information System–Physical Function- short-form (PROMIS-PF)(At baseline (0 week) and at end of 12th week)
- Pain Catastrophizing Scale (PCS)(At baseline (0 week) and at end of 12th week)
- Positive and Negative Affect Schedule (PANAS)(At baseline (0 week) and at end of 12th week)
- Tampa Scale for Kinesiophobia (TSK)(At baseline (0 week) and at end of 12th week)
- Pain Self-Efficacy Questionnaire (PSEQ)(At baseline (0 week) and at end of 12th week)
- Coping Strategies Questionnaire (CSQ)(At baseline (0 week) and at end of 12th week)