Clinical trial NCT05260918: Examining the Effects of Float-REST for Recovery in Individuals With Chronic Lower Back Pain
Official title: Understanding Physiology of Float-REST and the Consequential Effects on Subjective and Objective Recovery in Individuals With Chronic Lower Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Keywords: Sensory Deprivation Tank
fMRI
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in Functional Magnetic Resonance Imaging (fMRI)
timeFrame: 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).
Secondary outcomes:
measure: Change in Nocturnal Heart Rate as measured by OURA Ring
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in daily self-report measures for task load
timeFrame: Daily from baseline through study completion at 8 weeks
measure: Change in per session self-report measures
timeFrame: Before and after each float session (Weeks 2-7)
measure: Change in testing battery self-report measures in personality
timeFrame: Beginning and end of the investigation (Week 1 & Week 8)
measure: Change in testing battery self-report measures in emotional regulation
timeFrame: Beginning and end of the investigation (Week 1 & Week 8)
measure: Change in testing battery self-report measures in mindfulness
timeFrame: Beginning and end of the investigation (Week 1 & Week 8)
measure: Change in testing battery self-report measures in sleep quality
timeFrame: Beginning and end of the investigation (Week 1 & Week 8)
measure: Cold Pressor Stressor
timeFrame: 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.
measure: Serum Analysis for changes in Interleukin 1B concentration
timeFrame: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
measure: Serum Analysis for changes in Interleukin 6 concentration
timeFrame: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
measure: Serum Analysis for changes in Cortisol concentration
timeFrame: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
measure: Changes in Serum Analysis for changes in Dehydroepiandrosterone concentration
timeFrame: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Rockefeller Neuroscience Institute at West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Victor S Finomore, PhD
role: PRINCIPAL_INVESTIGATOR
References: