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

NCT05260918 | Completed

• 1 other identifier: 2010130921
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Keywords

Sensory Deprivation Tank; fMRI

Outcome Measures

Primary Outcomes (1)

• 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

  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 (12)

• Change in Nocturnal Heart Rate as measured by OURA Ring

  Daily from baseline through study completion at 8 weeks

• 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 emotional regulation

  Beginning and end of the investigation (Week 1 & Week 8)

Study Arms (2)

Flotation-REST

ACTIVE COMPARATOR

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.

Other: Float-REST

Nappod

PLACEBO COMPARATOR

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.

Other: Nappod

Interventions

Float-REST OTHER

Participants will utilize sensory deprivation tanks.

Flotation-REST

Nappod OTHER

Participants will utilize nappod.

Nappod

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Victor S Finomore, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: March 2, 2022
• Study Start: February 24, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-05

Locations

US (1)