Effects of Osteopathic Treatment in Combination With Cognitive Training on Low Back Pain Patients: a Randomised Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 216
- 试验地点
- 6
- 主要终点
- Change in NRS at 3 months
研究概览
简要总结
The objective of this study is to verify whether the combined approach (osteopathic manipulative treatment -OMT- and cognitive training -CT) is more effective in the long term than the individual approaches (OMT or CT) in patients with chronic lumbar pain, evaluating the Numeric Rating Scale (NRS) and the Rolland-Morris Disability Questionnaire (RMDQ) questionnaire
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 30 and 65 y
- •diagnosis of aspecific chronic low back pain
- •minimum of 3 on the NRS score
排除标准
- •Neuropathic pain or chronic widespread pain
- •Low back spinal surgery in the last three years
- •Low back spinal surgery to osteoporosis and/or traumatic fractures
- •Rheumatic disease
- •Pregnancy or having a baby in the last 12 months
- •Painful disease in evidence through RX, MRI or CT in the last 6 months (listesis, moderate arthrosis, severe, algodystrophy etc.).
- •The subjects have not to be treated with physical or manual therapies or psychotherapy in the last 6 months
结局指标
主要结局
Change in NRS at 3 months
时间窗: 3 months
Change from Baseline Numeric Rating Scale (NRS) of Pain at 3 months. NRS values range from 0-10, where 10 means highest pain and 0 no pain
Change in RMDQ at 3 months
时间窗: 3 months
Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 3 months. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)
次要结局
- Rate of AER(1 month - 3 month - 6 month)
- Changes in SCWT(1 month - 3 month - 6 month)
- Change in NRS at 1 month(1 month)
- Change in RMDQ at 6 months(6 months)
- Changes in CSI(1 month - 3 month - 6 month)
- BPQ(1 month - 3 month - 6 month)
- Changes in Oswestry(1 month - 3 month - 6 month)
- Changes in DASS-21(1 month - 3 month - 6 month)
- TMT(1 month - 3 month - 6 month)
- Change in NRS at 6 months(6 months)
- Changes in SF-36(1 month - 3 month - 6 month)
- Change in RMDQ at 1 month(1 month)