What is the Regional and Remote Effect of Spinal Manipulation on Pressure Pain Threshold in Asymptomatic Subjects Over Time: A Randomized Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change of the Pressure Pain threshold
研究概览
简要总结
Spinal manipulation is often used for its effect on pain, but more information is needed concerning its mechanisms of action.
详细描述
The effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects should be challenged by a validated sham procedure, regionally and remotely over time. Further information is needed concerning its duration and its size.
Research questions:
- What is the regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
- What is the remote effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
- What is the duration of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects?
- What is the size of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects over time?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects must be young (18-30 years old)
- •asymptomatic (no pain in the tested area, but the study accepts pain elsewhere, as long as it is less than 1/10 on the BOX-scale).
- •Chiropractic students.
排除标准
- •The subjects must not be reporting any spinal pain lasting more than a month
- •and/or having taken painkillers 24h prior to the study.
- •Contra-indications to the spinal manipulation (instability, fracture, malformation, bone or ligament fragility, and inflammations).
结局指标
主要结局
Change of the Pressure Pain threshold
时间窗: The change of the Pressure Pain Threshold is assessed from baseline to immediately after spinal manipulation, and then every fifteen minutes for about an hour.
Pressure Pain Threshold is defined as the minimal pressure that provokes a pain or a discomfort. It is considered as a valid and objective method, with a good reliability.
次要结局
未报告次要终点
研究者
Margaux Honoré
Principal investigator
Institut Franco Europeen de Chiropratique