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临床试验/CTRI/2012/11/003094
CTRI/2012/11/003094已完成不适用

YOGA THERAPY FOR LOW BACK PAIN: DIFFERENT RESPONSES OF DISC EXTRUSIONS AND BULGES

Patanjali Research Foundation1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2011年7月5日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
1. Health status measurement for low back pain (using Rolland Morris Disability recorded at questionnaire - RMDQ), 2. Physical examination of leg and back and 3. Magnetic resonance imaging (MRI) for lumbosacral spine (using Philips Magnetic Resonance Achieva 1.5T A-Series),

研究概览

简要总结

One hundred and twenty six participants of both sexes having lower back pain with ages between 20 and 45 years were randomly assigned to yoga and control groups using a computer generated random number table. In the yoga group, there were sixty three participants (32 males and 31 females) of both sexes (group mean ± S.D., 37.03 ± 6.76 years) and in the control group also; there were sixty three participants (33 males and 30 females) of both sexes (group mean ± S.D., 36.40 ± 6.54 years).Participants of both groups were staying close to a residential yoga center located in north India. All of them had lower back pain. Their participation in this study was voluntary. Prior to the study, signed informed consent of all participants was taken separately. The study protocol was approved by the Institutional Ethics Committee (IEC). Health status measurement for low back pain (using Rolland Morris Disability questionnaire - RMDQ), physical examination of leg and back, magnetic resonance imaging (MRI) for lumbosacral spine (using Philips Magnetic Resonance Achieva 1.5T A-Series), heart rate variability (HRV) and abdominal respiration (using a two channel EKG and respiration recording system; MP45 Biopac Student Lab, BIOPAC System Inc, U.S.A.), spinal flexibility (using Sit and Reach flexibility tester, model 01285A, Lafayette Instrument), the level of state anxiety (using Spielbergers State Trait Anxiety - STAI) and the level of back pain and mental stress (using analog scales) were measured. Assessments were done before and after three months of intervention. It was a randomized controlled study. Participants of the yoga group practiced loosening exercises, asanas, pranayamas and relaxation techniques in the morning (08:00 - 09:00 hours) thrice in a week for three months conducted by an experienced yoga teacher who had no other part in the trial. For the rest of the week, they were practicing yoga at home. Some educational classes were provided to the participants of the control group. Repeated measures analysis of variance (ANOVA) will be used to compare data recorded before and after three months with pre data, using PASW Version 18.0. There will be two Within subjects factors [Groups (Yoga, Control) and States (Pre, Post)].

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
20.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Age 20-45 years
  • Rolland Morris Questionnaire score >3 and/or acute sciatica in past three months
  • Presence of at least one disc herniation or bulge.

排除标准

  • Previous spinal surgery
  • Central canal stenosis
  • Severe osteoporosis
  • Pregnancy
  • Other disorders preventing active participation in therapy programme.

结局指标

主要结局

1. Health status measurement for low back pain (using Rolland Morris Disability recorded at questionnaire - RMDQ), 2. Physical examination of leg and back and 3. Magnetic resonance imaging (MRI) for lumbosacral spine (using Philips Magnetic Resonance Achieva 1.5T A-Series),

时间窗: Beginning and end of 3 months

次要结局

  • 1. Heart rate variability (HRV) and abdominal respiration (using a two channel EKG and respiration recording system; MP45 Biopac Student Lab, BIOPAC System Inc, U.S.A.), 2. Spinal flexibility (using Sit and Reach flexibility tester, model 01285A, Lafayette Instrument), 3. Level of state anxiety (using Spielbergers State Trait Anxiety - STAI) and 4. Level of back pain and mental stress (using analog scales)(Before and after 3 months)

研究者

申办方类型
Other [Private Research Organization]

研究点 (1)

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