Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain at 3 Months : a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Mean improvement from baseline in mean activity limitation
研究概览
简要总结
The purpose of this study is to determine whether a standardised osteopathic manipulative treatment is more effective than a placebo of osteopathic manipulative treatment, in sub-acute and chronic non-specific low back pain on functional recovery at 3 months.
详细描述
Sub-acute (4-12-week duration) and chronic (more than 3-month duration) non-specific low back pain (LBP) is frequent, disabling and costly. The effectiveness of usual treatments (including pain killers, anti-inflammatory drugs, spinal injections, physiotherapy, spinal traction, transcutaneous electrical nerve stimulation, etc) may be not sufficient, and many patients resort to alternative therapies. Manipulative treatments represent en emerging therapy in this area, although studies assessing their effectiveness are limited and often biased. The purpose of this study is to evaluate the efficacy of two manual therapies on improving functional recovery in sub-acute and chronic non-specific low back pain at 3 months. A standardised osteopathic manipulative treatment is compare to a placebo of osteopathic manipulative 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
- Single (Participant)
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
- •Patient consulting for subacute and chronic non-specific low
- •Male or female aged from 18 to 65 years (included)
- •Patient can speak and understand French
- •Patient giving his informed consent to participate in the study
- •Patient affiliated to or beneficiary of social insurance
排除标准
- •Specific low-back pain caused by inflammatory, tumoral, infectious disease or a back traumatism in the 3 past months
- •History of back surgery and/or vertebral fracture in the previous 6 months
- •Presence of a motor impairment related to the reason for consultation
- •The patient is a student or a practitioner in manipulative therapies
- •Pregnancy
- •Inability to understand the process of the study
- •The patient is already included in another clinical study
研究组 & 干预措施
Osteopathic manipulative treatment
6 sessions of standardized manipulative treatment
干预措施: Osteopathic manipulative treatment (Other)
Placebo of osteopathic manipulative treatment
6 sessions of standardized placebo of manipulative treatment
干预措施: Placebo of osteopathic manipulative treatment (Other)
结局指标
主要结局
Mean improvement from baseline in mean activity limitation
时间窗: 3 months after randomization
Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)
次要结局
- Mean improvement from baseline in mean activity limitation(12 months after randomization)
- Duration of sick leaves(12 months after randomization)
- Pain killer and non-steroidal anti-inflammatory drug consumption(12 months after randomization)
- Mean reduction from baseline in mean lumbar pain in the previous 48 hrs(12 months after randomization)
- Number of sick leaves(12 months after randomization)
- Recurrence of pain(12 months after randomization)
- Mean improvement from baseline in mean quality of life(12 months after randomization)