The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity in Healthy Subjects: a Randomized, Cross-over, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Heart rate variability (HRV)
研究概览
简要总结
This study evaluates the effect of a single high-velocity low-amplitude spinal manipulation on both cardiovascular autonomic activity and pressure pain thresholds.
It is a cross-over study, thus each participant will undergo both interventions (spinal manipulation and sham manipulation). Both interventions will be separated by a 48 h wash-out period.
详细描述
Several systematic reviews have shown that spinal manipulations may have an immediate effect on autonomic nervous system activity (e.g. increase in skin sympathetic nerve activity) and on sensitivity to experimentally-induced pain (e.g. increase in pressure pain threshold).
It is generally unknown i) if these supposed effects last after the immediate post intervention period and ii) if there is a statistical relationship between them, considering that pain and autonomic networks are closely connected and interact at the peripheral, spinal and supra-spinal levels.
The primary aim of the study is to assess every single effect immediatly and at short-term after the intervention.
The secondary aim is to assess the bivariate statistical relationship between cardiovascular autonomic activity and sensitivity to experimentally-induced pain after the intervention.
Cardiovascular autonomic nervous system activity is assessed with both heart rate and systolic blood variabilities
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First-year chiropractic student at IFEC
- •Volunteer
- •Healthy (no pain, no disease)
排除标准
- •Counter indications to spinal manipulation
- •Drugs intakes (pain killers or beta-blockers)
- •Food, Caffeine and tobacco intakes during the previous hour
- •Alcohol intake and performance of strenuous physical activity the day of the experimentation
研究组 & 干预措施
High velocity low amplitude manipulation
干预措施: High velocity low amplitude manipulation (Other)
Sham manipulation
干预措施: Sham manipulation (Other)
结局指标
主要结局
Heart rate variability (HRV)
时间窗: Baseline, + 5 minutes, + 15 minutes, + 30 minutes
Frequency and Time-domain analyses of HRV from 5-minutes ECG recording
Local (T5) and distal (L4) Pressure pain thresholds (PPT)
时间窗: Baseline, immediatly after intervention, + 12 minutes, + 25 minutes, + 35 minutes
The mean of 3 successives PPT in kilopascal
次要结局
- Systolic blood pressure variability(Baseline, + 5 minutes, + 15 minutes, + 30 minutes)
研究者
Mathieu Picchiottino
Chiropractor, PhD student
Institut Franco Europeen de Chiropratique