Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis. A PARALLEL, RANDOMIZED AND DOUBLE-BLIND CONTROLLED PILOT STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Disability will be assessed using the ODQ
研究概览
简要总结
The aim of our study is to assess the effect of a combined physiotherapy and osteopathy treatment versus a placebo on the management of disability and quality of life after lumbar arthrodesis. This study will provide a better assessment of the use of osteopathy as a non pharmacological approach to post-operative management.
For this purpose, We will analyze the effects of these two approaches, targeted and non-targeted osteopathy (TO vs. NTO), on patients' disability and quality of life after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having experienced a lumbar arthrodesis (of one to three levels) four weeks before inclusion
- •being under a stable pharmacological treatment over the last month
- •who are suffering from postoperative mechanical pain (VAS ≥ 4)
排除标准
- •neuropathic pain according to a DN4 score greater than or equal to 4/10,
- •are suffering from fibromyalgia,
- •algodystrophy,
- •other somatic or neuropsychiatric diseases (other than depression and anxiety),
- •have received osteopathic treatment over the last three month prior to inclusion,
- •are included in another interventional research protocol during the study period
研究组 & 干预措施
Targeted osteopathic treatment
treatment with real osteopathy
干预措施: osteopathy real (Other)
Non-targeted osteopathic treatment
treatment with sham osteopathy
干预措施: sham osteopathy (Other)
结局指标
主要结局
Disability will be assessed using the ODQ
时间窗: baseline and Week 8
Oswestry Low Back Pain Disability Questionnaire * Minimum Value: 0 * Maximum Value: 100 * Interpretation: Higher scores indicate a worse outcome =\> greater disability due to low back pain.
次要结局
- Pain and disability measures(baseline, ans every week from 1 to 8)
- The Osteopathic Dysfunction Palpation Assessment Scale(baseline and Week 8)