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Examining the Effects of Float-REST for Recovery in Individuals With Chronic Lower Back Pain

Primary Purpose

Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Float-REST
Nappod
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain, Chronic focused on measuring Sensory Deprivation Tank, fMRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rockefeller Neuroscience Institute at West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Flotation-REST

Nappod

Arm Description

Float-REST therapy uses sensory deprivation tanks that consist of a very large warm water enclosure with a high concentration of Epsom salt to create a completely buoyant environment. This, along with a combination of temperature that is kept equal to skin temperature (94 degrees), allows the participant to eliminate the gravitational effects on the body, and along with lack of sound and low to no light (depending on comfort) allows the brain and body to completely relax for augmented physical and mental recovery. The room will contain an intercom that allows participants to communicate with study personnel in the event the participant needs assistance. Participants will undergo 60 minute sessions twice a week for 3 weeks.

Participants in this arm will be asked to lie comfortably in a special recliner called a Metro Nappod for the duration of a 60 minute session twice a week for 3 weeks. The chair is located in a quiet and dimly lit room to minimize interruptions. The pod is equipped with a privacy visor, built-in speaker, and a timer with an alarm.

Outcomes

Primary Outcome Measures

Changes in Functional Magnetic Resonance Imaging (fMRI)
fMRI analysis looks at alterations in brain activity from baseline at rest and in response to pain cues

Secondary Outcome Measures

Change in Nocturnal Heart Rate as measured by OURA Ring
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Change in daily self-report measures for task load
End of Day Questionnaire (EoD)-Developed at the Rockefeller Neuroscience Institute (RNI) as a modification of the NASA Task Load Index. There are 5 Likert scales to assess workload (0=very low and 100=very high), as well as 4 follow up questions. This questionnaire addresses subjective measures of workload and stressors that were encountered throughout the day.
Change in per session self-report measures
State-Trait Anxiety Index (STAI) - Commonly used measure of state and trait anxiety, and done with 20 very brief questions. Values range from 20 to 80, with higher scores representing more severe anxiety. Participants will complete the STAI questionnaire before and after each session, twice a week.
Change in testing battery self-report measures in personality
Big Five Inventory (BFI)-44 item inventory designed to measure the Big Five Factors of personality on a 5-point Likert Scale. Higher scores indicate a higher tendency for that personality trait (1=disagree strongly to 5=agree strongly).
Change in testing battery self-report measures in emotional regulation
Emotion Regulation Questionnaire (ERQ)-10-item scale designed to measure tendency to regulate emotions. Each item is answered on a 7-point Likert Scale (1=strongly disagree to 7=strongly agree). Higher scores indicate a higher emotion regulation strategy.
Change in testing battery self-report measures in mindfulness
Five Facet Mindfulness Questionnaire (FFMQ)-39 item inventory assesses the five facets of mindfulness on a 5-point Likert Scale (1=never or very rarely true and 5=very often or always true). Each facet is tallied and the sum total responses are divided by 39 (number of items). Higher scores indicate higher levels of mindfulness.
Change in testing battery self-report measures in sleep quality
Pittsburgh Sleep Quality Index (PSQI)- 19 item inventory with 7 subjective components that assess sleep quality over time. Each component is scored from 0 to 3 (0=very good and 3=very bad). The sum of the components is the global score and ranges 0-21 (0=no difficulty and 21=severe difficulties). The higher the global score, the poorer the sleep quality.
Cold Pressor Stressor
The cold pressor is a water bath with its temperature maintained at 3C. The participant is asked to submerge a hand in the water bath. The water is cold enough to be a painful stimuli but not so cold as to cause tissue damage. The participant rates their pain level on a standard Wong-Baker pain scale prior and immediately after voluntary withdraw from the cold pressor. The Wong Baker pain scale asks the participant to rate their pain on a scale of 0-10 with 0= no pain and 10= the most pain. Duration of time spent in the water is also recorded.
Serum Analysis for changes in Interleukin 1B concentration
Blood samples will be collected through out the study and analyzed for a key stress indicators Interleukin 1B.
Serum Analysis for changes in Interleukin 6 concentration
Blood samples will be collected through out the study and analyzed for a key stress indicators Interleukin 6.
Serum Analysis for changes in Cortisol concentration
Blood samples will be collected through out the study and analyzed for a key stress indicator Cortisol.
Changes in Serum Analysis for changes in Dehydroepiandrosterone concentration
Blood samples will be collected through out the study and analyzed for a key stress indicator Dehydroepiandrosterone.

Full Information

First Posted
January 13, 2022
Last Updated
July 19, 2023
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT05260918
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
Sensory Deprivation Tank, fMRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flotation-REST
Arm Type
Active Comparator
Arm Description
Float-REST therapy uses sensory deprivation tanks that consist of a very large warm water enclosure with a high concentration of Epsom salt to create a completely buoyant environment. This, along with a combination of temperature that is kept equal to skin temperature (94 degrees), allows the participant to eliminate the gravitational effects on the body, and along with lack of sound and low to no light (depending on comfort) allows the brain and body to completely relax for augmented physical and mental recovery. The room will contain an intercom that allows participants to communicate with study personnel in the event the participant needs assistance. Participants will undergo 60 minute sessions twice a week for 3 weeks.
Arm Title
Nappod
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will be asked to lie comfortably in a special recliner called a Metro Nappod for the duration of a 60 minute session twice a week for 3 weeks. The chair is located in a quiet and dimly lit room to minimize interruptions. The pod is equipped with a privacy visor, built-in speaker, and a timer with an alarm.
Intervention Type
Other
Intervention Name(s)
Float-REST
Intervention Description
Participants will utilize sensory deprivation tanks.
Intervention Type
Other
Intervention Name(s)
Nappod
Intervention Description
Participants will utilize nappod.
Primary Outcome Measure Information:
Title
Changes in Functional Magnetic Resonance Imaging (fMRI)
Description
fMRI analysis looks at alterations in brain activity from baseline at rest and in response to pain cues
Time Frame
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 Outcome Measure Information:
Title
Change in Nocturnal Heart Rate as measured by OURA Ring
Description
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Time Frame
Daily from baseline through study completion at 8 weeks
Title
Change in daily self-report measures for task load
Description
End of Day Questionnaire (EoD)-Developed at the Rockefeller Neuroscience Institute (RNI) as a modification of the NASA Task Load Index. There are 5 Likert scales to assess workload (0=very low and 100=very high), as well as 4 follow up questions. This questionnaire addresses subjective measures of workload and stressors that were encountered throughout the day.
Time Frame
Daily from baseline through study completion at 8 weeks
Title
Change in per session self-report measures
Description
State-Trait Anxiety Index (STAI) - Commonly used measure of state and trait anxiety, and done with 20 very brief questions. Values range from 20 to 80, with higher scores representing more severe anxiety. Participants will complete the STAI questionnaire before and after each session, twice a week.
Time Frame
Before and after each float session (Weeks 2-7)
Title
Change in testing battery self-report measures in personality
Description
Big Five Inventory (BFI)-44 item inventory designed to measure the Big Five Factors of personality on a 5-point Likert Scale. Higher scores indicate a higher tendency for that personality trait (1=disagree strongly to 5=agree strongly).
Time Frame
Beginning and end of the investigation (Week 1 & Week 8)
Title
Change in testing battery self-report measures in emotional regulation
Description
Emotion Regulation Questionnaire (ERQ)-10-item scale designed to measure tendency to regulate emotions. Each item is answered on a 7-point Likert Scale (1=strongly disagree to 7=strongly agree). Higher scores indicate a higher emotion regulation strategy.
Time Frame
Beginning and end of the investigation (Week 1 & Week 8)
Title
Change in testing battery self-report measures in mindfulness
Description
Five Facet Mindfulness Questionnaire (FFMQ)-39 item inventory assesses the five facets of mindfulness on a 5-point Likert Scale (1=never or very rarely true and 5=very often or always true). Each facet is tallied and the sum total responses are divided by 39 (number of items). Higher scores indicate higher levels of mindfulness.
Time Frame
Beginning and end of the investigation (Week 1 & Week 8)
Title
Change in testing battery self-report measures in sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI)- 19 item inventory with 7 subjective components that assess sleep quality over time. Each component is scored from 0 to 3 (0=very good and 3=very bad). The sum of the components is the global score and ranges 0-21 (0=no difficulty and 21=severe difficulties). The higher the global score, the poorer the sleep quality.
Time Frame
Beginning and end of the investigation (Week 1 & Week 8)
Title
Cold Pressor Stressor
Description
The cold pressor is a water bath with its temperature maintained at 3C. The participant is asked to submerge a hand in the water bath. The water is cold enough to be a painful stimuli but not so cold as to cause tissue damage. The participant rates their pain level on a standard Wong-Baker pain scale prior and immediately after voluntary withdraw from the cold pressor. The Wong Baker pain scale asks the participant to rate their pain on a scale of 0-10 with 0= no pain and 10= the most pain. Duration of time spent in the water is also recorded.
Time Frame
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.
Title
Serum Analysis for changes in Interleukin 1B concentration
Description
Blood samples will be collected through out the study and analyzed for a key stress indicators Interleukin 1B.
Time Frame
Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Title
Serum Analysis for changes in Interleukin 6 concentration
Description
Blood samples will be collected through out the study and analyzed for a key stress indicators Interleukin 6.
Time Frame
Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Title
Serum Analysis for changes in Cortisol concentration
Description
Blood samples will be collected through out the study and analyzed for a key stress indicator Cortisol.
Time Frame
Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Title
Changes in Serum Analysis for changes in Dehydroepiandrosterone concentration
Description
Blood samples will be collected through out the study and analyzed for a key stress indicator Dehydroepiandrosterone.
Time Frame
Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor S Finomore, PhD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockefeller Neuroscience Institute at West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

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Examining the Effects of Float-REST for Recovery in Individuals With Chronic Lower Back Pain

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