Understanding Physiology of Float-REST and the Consequential Effects on Subjective and Objective Recovery in Individuals With Chronic Lower Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Changes in Functional Magnetic Resonance Imaging (fMRI)
研究概览
简要总结
Researchers at the West Virginia University Rockefeller Neuroscience Institute are looking for volunteers to participate in a research study to evaluate what effects Float-REST (Restricted environmental Stimulation Technique) has on the stress response caused by chronic lower back pain.
详细描述
Chronic lower back pain has a profound impact on a patient's life and body. These patients face a litany of internal and external stressors. These stressors cause a detrimental sustained activation of the endogenous stress response, which is mediated by the autonomic nervous system. Our central hypothesis is that this high stress load exacerbates the symptoms of chronic pain by causing changes in how the brain processes pain signals from the periphery. If researchers can better understand how stress plays a role in the mitigation of pain, then there may be improvements in patient's quality of life. Restricted Environmental Stimulation Therapy (REST) flotation has been identified as a possible alternative treatment to pharmacological intervention for several conditions like generalized anxiety disorder by helping to reduce stress. However, there have yet to be any investigation into what affects that REST flotation has in chronic lower back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Able and willing to give informed consent
- •Right-hand dominant
- •Naïve to mindfulness interventions (i.e. guided meditation, guided yoga, previous REST flotation)
- •Have chronic lower back pain (at least 12 weeks since onset)
- •Ability to enter/exit REST Flotation Tank unassisted
- •Stable prescription medication (No changes in dose, start/stop within 30 days of the beginning of the study)
排除标准
- •MRI incompatibility: The participant cannot have any non-MRI compatible metallic (magnetic) material in, on, or attached to their body.
- •Current fear of small spaces or water
- •Current balance problems or motion sickness
- •Body width greater than 60cm
- •Current contagious skin condition
结局指标
主要结局
Changes in Functional Magnetic Resonance Imaging (fMRI)
时间窗: Participants will undergo an fMRI session at the beginning (Week 1) to establish a baseline and a follow up end of the study (Week 8).
fMRI analysis looks at alterations in brain activity from baseline at rest and in response to pain cues
次要结局
- Change in daily self-report measures for task load(Daily from baseline through study completion at 8 weeks)
- Change in per session self-report measures(Before and after each float session (Weeks 2-7))
- Change in testing battery self-report measures in personality(Beginning and end of the investigation (Week 1 & Week 8))
- Change in testing battery self-report measures in sleep quality(Beginning and end of the investigation (Week 1 & Week 8))
- Change in Nocturnal Heart Rate as measured by OURA Ring(Daily from baseline through study completion at 8 weeks)
- Change in testing battery self-report measures in emotional regulation(Beginning and end of the investigation (Week 1 & Week 8))
- Change in testing battery self-report measures in mindfulness(Beginning and end of the investigation (Week 1 & Week 8))
- Cold Pressor Stressor(The participant will undergo the cold pressor test at the beginning (Week 1) and end of the study (Week 8) with the option for an additional session after a few sessions at the investigators discretion.)
- Changes in Serum Analysis for changes in Dehydroepiandrosterone concentration(Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8))
- Serum Analysis for changes in Interleukin 1B concentration(Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8))
- Serum Analysis for changes in Interleukin 6 concentration(Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8))
- Serum Analysis for changes in Cortisol concentration(Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8))