Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Pain VAS Visual Analog Scale
研究概览
简要总结
The management of chronic low back pain is now part of a multi-disciplinary set of proposals with the aim of adapting for each patient orientations of both medicated and non-medicated care.
Very classically, analgesic treatment of stage I or II is of use, reinforced by the occasional use of NSAIDs in the absence of contraindication. In this medical attempt of the control of the pain associates a physical care (supervised exercises, physiotherapy care), cognitive and behavioral therapy, multidisciplinary care.
Osteopathic treatment is a specific manual diagnostic and therapeutic procedure.
This study aims to evaluate the relevance of providing osteopathic treatment in combination with classical medical treatment in the management of patients with chronic non-specific low back pain.
详细描述
The primary objective is to show that the addition of osteopathic treatment to classical medical treatment decreases pain for patients with chronic nonspecific low back pain.
This goal will be evaluated at 3 months by comparing
- the 3-month change in the level of pain observed in arm 3 (classical medical treatment + osteopathic treatment) versus that observed in arm 1 (classical medical treatment), and
- the 3-month change in the level of pain observed in arm 3 (classical medical treatment + osteopathic treatment) versus that observed in arm 2 (classical medical treatment+ sham osteopathic treatment ).
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with chronic non-specific low back pain: degenerative lumbalgia and low back pain unrelated to anatomical lesions that have been evolving for more than 3 months.
- •Patient affiliated with a social security scheme or equivalent
- •Patient having signed the study informed consent form.
排除标准
- •Patient with specific low back pain: patient with one of the following pathologies: degenerative neurological pathology; infectious pathology; fracture vertebral lesion less than 1 year; vertebral osteosynthesis material or canal narrowing.
- •Patient following a treatment of the Morphinic or Neuroleptic type.
- •Pregnant, breastfeeding or parturient woman
- •Patient participating in another clinical study
- •Protected patient: Major under some form of guardianship ; Hospitalized without consent
研究组 & 干预措施
1-Current practice Medication treatment
Medication treatment according to current practice.
干预措施: Current practice Medication treatment (Other)
2- Sham osteopathic treatment
Medication treatment according to current practice + sham osteopathic treatment.
干预措施: Sham osteopathic treatment (Other)
2- Sham osteopathic treatment
Medication treatment according to current practice + sham osteopathic treatment.
干预措施: Current practice Medication treatment (Other)
3- Osteopathic treatment
Medication treatment according to current practice + osteopathic treatment.
干预措施: Osteopathic treatment (Other)
3- Osteopathic treatment
Medication treatment according to current practice + osteopathic treatment.
干预措施: Current practice Medication treatment (Other)
结局指标
主要结局
Pain VAS Visual Analog Scale
时间窗: Change from baseline to 3 months
The primary outcome is the change in the VAS score on a 0-100 mm scale between Day 0 (before the placement of any osteopathic manipulations for Arm 3 ( or sham osteopathic treatment for Arm 2) and J90 ( after the last osteopathic treatment session for Arm 3 (sham osteopathic treatment for Arm 2)).
次要结局
- Pain VAS , level improvement(Baseline, Day 15, Month 1, Month 2, Month 3, Month 6)
- Hand-Ground Distance and Schöber test(Baseline, Day 15, Month 1, Month 2, Month 3, Month 6)
- Adverse event(Day 15, Month 1, Month 2, Month 3, Month 6)
- Drug consumption(Baseline, Day 15, Month 1, Month 2, Month 3, Month 6)
- Relief Numerical scale(Day 15, Month 1, Month 2, Month 3, Month 6)
- Elements of the osteopathic diagnosis(Day 1, Day 7, Day 15, Month 1 Month 2)
- Oswestry score(Baseline, Day 15, Month 1, Month 2, Month 3, Month 6)
研究者
Barthélémy de Truchis
Principal investigator, MD
Clinique Pasteur