CTRI/2024/08/072259尚未招募3 期
Individualized physiotherapy versus usual care (STOPS trial) for Low Back Disorders in India: A Randomized Clinical Trial
Dr Kavitha Raja1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2024年8月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- 1. Oswestry Disability Index V2.1 with “sex life†question replaced
研究概览
简要总结
People with low-back pain (LBP) commonly have poor outcomes. This is partly because LBP can be a complex condition where a single treatment approach may not achieve optimal outcomes for all patients. The application of generic treatment may also be a factor in the mixed results of randomised controlled trials (RCTs) that evaluated physiotherapy. The Specific Treatment of Problems of the Spine (STOPS) trial has been previously conducted across multiple primary care physiotherapy practices in Melbourne, Australia, demonstrating clinically important improvements in pain and disability compared to guideline-based treatment. A clinical trial to evaluate the STOPS approach in Asia is planned to commence at JSS College of Physiotherapy Clinic, Mysore India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •A primary complaint of either: a.
- •low back pain, defined as pain between the inferior costal margin and the inferior gluteal fold with or without referral into the leg(s), or b.
- •referred leg pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, with or without back pain (disc herniation with associated radiculopathy subgroup only)
- •Duration of the current episode of primary complaint lasting for greater than 3 months (chronic stage of the injury)
- •Aged between 18 and 65 (inclusive)
- •Fluency in English, Kannada or Hindi languages sufficient to complete questionnaires and to enable understanding of the intervention
- •Agreeing to refrain from other interventions wherever possible for the 10-week treatment period of the trial, aside from consultations with medical practitioners, medication, and any exercises already being undertaken.
排除标准
- •Active cancer under current treatment
- •Signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging
- •Current pregnancy, or childbirth within the last 6 months
- •Spinal injections within the last 6 weeks, as we wish to study treatment effects independent of the effects of injections
- •Any history of lumbar spine surgery
- •A pain intensity score of less than 2/10 on a 0-10 numerical rating scale due to low severity
- •Minimal activity limitation, evidenced by a baseline ability to walk, sit, and stand for one hour or more and no sleep disturbance at night, as we wish to exclude people with low severity
- •Already received more than 5 sessions of physiotherapy with any of the treating physiotherapists before enrolment, as these therapists are likely to use many components of the trial treatment protocol on their usual client caseload
- •Inability to walk safely, such as severe foot drop causing regular tripping, as the interventions in the trial include walking for most participants
- •Planned absence of more than one week during the treatment period (such as overseas holidays).
结局指标
主要结局
1. Oswestry Disability Index V2.1 with “sex life†question replaced
时间窗: 0, 5, 10, 26 and 52 weeks
by a “work/housework†question
时间窗: 0, 5, 10, 26 and 52 weeks
次要结局
- 1. Global rating of change scale (7-point Likert scale)(2. Satisfaction with treatment (5-point Likert scale))
- 6. Interference with work or housework in the past week (5-(point Likert scale) and the number of hours missed at work in)
- 17. Compliance with treatment(5th, 10th, 26th and 52nd weeks)
- 18. Resting state and task based functional MRI (only from a cohort of the sample)(Baseline and 11th week)
- 19. Qualitative interviews(At the end of treatment trial (10th week))
- 20. Treatment effect modifiers and mediators.
- 21. Average back pain intensity over the last week, measured on the 0-10 numerical pain rating scale(22. Average leg pain intensity over the last week, measured on the 0-10 numerical pain rating scale)
研究者
Dr Kavitha Raja
JSS College of Physiotehrapy
研究点 (1)
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