Floating for Chronic Pain (Float4Pain)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change in Pain intensity (maximum and average) as compared to baseline
研究概览
简要总结
In recent years there has been a novel approach for the treatment of chronic pain: Floatation REST (restricted environmental stimulation therapy). Floating is a therapeutic approach, in which patients float in a specialized pool or tank on water that contains high concentrations of Epsom salt (Magnesium sulfate). Water is kept at skin temperature (35-36°C) and the pool or tank is shielded to provide almost complete darkness and silence. This therapeutic approach has proven to be effective in alleviating chronic pain.
Due to the difficulties associated with designing a credible placebo control there have been no randomized controlled trials (RCTs) with patients blinding so far. Such blinding, however, is crucial, to assess the true therapeutic effect of the intervention.
The investigators will conduct the first patient blinded RCT of Floatation REST for chronic pain with a credible placebo control for floating and a no-treatment group.
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
- Double (Participant, 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
- •Current diagnosis of chronic pain disorder with somatic and psychological factors (German ICD F45.41)
- •Able and willing to give written informed consent
排除标准
- •Pregnant or nursing women (self report)
- •Previous experience with floating
- •Acute illnesses that may exacerbate or shadow the chronic pain condition (acute inflammation, major depression, active neoplasm, etc.)
- •History of alcohol and drug abuse
- •Any clinically relevant abnormal findings in the clinical history, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study or the subject's ability to participate in the study.
- •Any clinical condition that may prevent the subject from floating, such as: open injuries, contagious diseases (influenza, GI infections, athlete's foot), GERD, epilepsy, claustrophobia, schizophrenia, incontinence or acute skin disorders.
- •Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
研究组 & 干预措施
Intervention group
Floating
干预措施: Floating (Other)
Control group
Placebo floating
干预措施: Placebo floating (Other)
No-treatment group
Waiting list
结局指标
主要结局
Change in Pain intensity (maximum and average) as compared to baseline
时间窗: 1, 12 and 24 weeks after intervention
Numeric rating scales from 0 ("no pain") to 100 ("maximum imaginable pain"), assessing retrospectively the week before.
次要结局
- Change in pain-related disability as compared to baseline(1, 12 and 24 weeks after intervention)
- Change in pain intensity(Immediately before - immediately after every float session)
- Change in pain area and widespreadness(Immediately before - immediately after every float session)
- Change in heart rate(Immediately before - immediately after every float session)
- Change in high frequency (HF) power of heart rate(Immediately before - immediately after every float session)
- Change in low frequency (LF) power of heart rate(Immediately before - immediately after every float session)
- Change in the standard deviation of NN intervals (SDNN)(Immediately before - immediately after every float session)
- Change in Pain scores (maximum and average, dichotomous) as compared to baseline(1, 12 and 24 weeks after intervention)
- Change in depression as compared to baseline(1, 12 and 24 weeks after intervention)
- Change in quality of sleep assessed by a numeric rating scale as compared to baseline(1, 12 and 24 weeks after intervention)
- Change in state anxiety(Immediately before - immediately after every float session)
- Change in the LF/HF ratio of heart rate(Immediately before - immediately after every float session)
- Change in the proportion of NN50 divided by total number of NNs (pNN50)(Immediately before - immediately after every float session)
- Change in relaxation(Immediately before - immediately after every float session)
- Change in use of pain medication as compared to baseline(1, 12 and 24 weeks after intervention)
- Change in the root mean square of successive differences (RMSSD)(Immediately before - immediately after every float session)
- Change in the coefficient of variation (CV)(Immediately before - immediately after every float session)
- Change in trait anxiety as compared to baseline(1, 12 and 24 weeks after intervention)
- Change in pain widespreadness as compared to baseline(1 week after intervention)
- Change in physical and mental health as compared to baseline(1, 12 and 24 weeks after intervention)
- Change in pain area as compared to baseline(1 week after intervention)
- Unusual bodily sensations during floating(During floating)
研究者
Beißner, Florian Prof. Dr.
Principal Investigator
Hannover Medical School