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

Pain, Chronic Clinical Trial

Official title:

Understanding Physiology of Float-REST and the Consequential Effects on Subjective and Objective Recovery in Individuals With Chronic Lower Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260918
• Other study ID #: 2010130921
• Status: Completed
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2023
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain
• Pain, Chronic

Intervention

Other:
• Float-REST
Participants will utilize sensory deprivation tanks.
• Nappod
Participants will utilize nappod.

Locations

Country	Name	City	State
United States	Rockefeller Neuroscience Institute at West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Daily from baseline through study completion at 8 weeks
Secondary	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.	Daily from baseline through study completion at 8 weeks
Secondary	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.	Before and after each float session (Weeks 2-7)
Secondary	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).	Beginning and end of the investigation (Week 1 & Week 8)
Secondary	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.	Beginning and end of the investigation (Week 1 & Week 8)
Secondary	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.	Beginning and end of the investigation (Week 1 & Week 8)
Secondary	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.	Beginning and end of the investigation (Week 1 & Week 8)
Secondary	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.	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.
Secondary	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.	Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Secondary	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.	Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Secondary	Serum Analysis for changes in Cortisol concentration	Blood samples will be collected through out the study and analyzed for a key stress indicator Cortisol.	Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Secondary	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.	Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)