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

NCT ID: NCT05260918

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-24
• Study Completion Date: 2023-01-01

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.

Conditions

Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Flotation-REST

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.

Group Type: ACTIVE_COMPARATOR

Float-REST

Intervention Type: OTHER

Participants will utilize sensory deprivation tanks.

Nappod

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.

Group Type: PLACEBO_COMPARATOR

Nappod

Intervention Type: OTHER

Participants will utilize nappod.

Interventions

Float-REST

Participants will utilize sensory deprivation tanks.

Intervention Type: OTHER

Nappod

Participants will utilize nappod.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor S Finomore, PhD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

2010130921

Identifier Type: -

Identifier Source: org_study_id