Effectiveness of TENS and Supervised Motor Control Exercises Compared To Unsupervised Exercises in Subjects With Chronic Low Back Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Disability (Nepali version of Oswestry Disability Index (NODI)
研究概览
简要总结
The purpose of this study is to compare the added effects of TENS and Supervised Motor Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain and other outcomes.
详细描述
Chronic low back pain (CLBP) is a common problem causing disability and high economic burden in globally as well as in Nepal. There is no consensus on treatment of CLBP, however motor control exercises have good evidence on improvement in pain and disability in CLBP population, whereas transcutaneous electrical nerve stimulation (TENS) is a common treatment of choice with some evidence. But, we do not know if supervising these motor control exercises (SMCE) and TENS have any added benefit over home exercise program (HEP) which is commonly prescribed mode of exercises. We plan to conduct a three armed randomized control trial to answer this question to compare effects of SMCE, TENS and HEP versus SMCE and HEP versus HEP alone on disability and pain at two weeks and six months follow up. Three way-mixed model analysis of Variance (ANOVA) will be used as the statistical test. Appropriate post hoc analysis will be done to compare within group and between group differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonspecific Low back pain for more than 3 months with pain primarily localized between T12 and gluteal folds, if patients report that their pain is provoked and relieved with postures, movement and activities.
- •Age between 18 to 65 years
- •Male or female
- •All educational backgrounds (educated or uneducated)
- •Pain intensity more than 2/10 on NPRS and
- •Disability of more than 20/100 on NODI
排除标准
- •Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
- •Signs consistent with nerve root compression, this includes any one of the following:
- •Reproduction of low back or leg pain with straight leg raise at less than 45 degrees
- •Muscle weakness involving a major muscle group of the lower extremity
- •Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
- •Diminished or absent sensation to pinprick in any lower extremity dermatome
- •Prior surgery to the lumbar spine or buttock
- •Current pregnancy
- •Past medical history of osteoporosis or spinal compression fracture
- •Participants who do not provide informed consent for the study
结局指标
主要结局
Disability (Nepali version of Oswestry Disability Index (NODI)
时间窗: 2 weeks
Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal. The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875)
次要结局
- Pain intensity (Numerical Pain Rating Scale (NPRS)(6 months)
- Disability (Nepali version of Oswestry Disability Index (NODI)(6 months)
研究者
Saurab Sharma
MPT
Kathmandu University School of Medical Sciences