Pain, ChronicNCT05260918
Examining the Effects of Float-REST for Recovery in Individuals With Chronic Lower Back Pain
A study testing Float-REST and Nappod in people with Pain, Chronic, run by West Virginia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Float-REST and Nappod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, 26505
About this study
Official title: Understanding Physiology of Float-REST and the Consequential Effects on Subjective and Objective Recovery in Individuals With Chronic Lower Back Pain
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.
Read the 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
- Being tested
- Float-REST, Nappod
- Keywords
- Sensory Deprivation Tank, fMRI
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Float-RESTOther
Participants will utilize sensory deprivation tanks.
NappodOther
Participants will utilize nappod.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Nappod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Measured: Daily from baseline through study completion at 8 weeks
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.
Measured: Daily from baseline through study completion at 8 weeks
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.
Measured: Before and after each float session (Weeks 2-7)
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).
Measured: Beginning and end of the investigation (Week 1 & Week 8)
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.
Measured: Beginning and end of the investigation (Week 1 & Week 8)
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.
Measured: Beginning and end of the investigation (Week 1 & Week 8)
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.
Measured: Beginning and end of the investigation (Week 1 & Week 8)
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.
Measured: 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.
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.
Measured: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
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.
Measured: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Serum Analysis for changes in Cortisol concentration
Blood samples will be collected through out the study and analyzed for a key stress indicator Cortisol.
Measured: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
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.
Measured: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start24 Feb 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor S Finomore, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260918
- Sponsor's protocol ID
- 2010130921
- Status last verified
- May 2023
- First submitted
- 13 Jan 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Physiology of Float-REST and the Consequential Effects on Subjective and Objective Recovery in Individuals With Chronic Lower Back Pain
- ClinicalTrials.gov ID
- NCT05260918
- Acronym / sponsor ID
- 2010130921
- Conditions
- Pain, Chronic
- Keywords
- Sensory Deprivation Tank, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flotation-REST | Active comparator | Other: Float-RESTFloat-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. |
| Nappod | Placebo comparator | Other: NappodParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Float-RESTParticipants will utilize sensory deprivation tanks. | Other | Flotation-REST |
| NappodParticipants will utilize nappod. | Other | Nappod |
Primary outcome
Changes in Functional Magnetic Resonance Imaging (fMRI)
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).
fMRI analysis looks at alterations in brain activity from baseline at rest and in response to pain cues
12 secondary outcomes
Change in Nocturnal Heart Rate as measured by OURA Ring
Time frame: Daily from baseline through study completion at 8 weeks
Change in daily self-report measures for task load
Time frame: Daily from baseline through study completion at 8 weeks
Change in per session self-report measures
Time frame: Before and after each float session (Weeks 2-7)
Change in testing battery self-report measures in personality
Time frame: Beginning and end of the investigation (Week 1 & Week 8)
Change in testing battery self-report measures in emotional regulation
Time frame: Beginning and end of the investigation (Week 1 & Week 8)
Change in testing battery self-report measures in mindfulness
Time frame: Beginning and end of the investigation (Week 1 & Week 8)
Change in testing battery self-report measures in sleep quality
Time frame: Beginning and end of the investigation (Week 1 & Week 8)
Cold Pressor Stressor
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.
Serum Analysis for changes in Interleukin 1B concentration
Time frame: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Serum Analysis for changes in Interleukin 6 concentration
Time frame: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Serum Analysis for changes in Cortisol concentration
Time frame: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Changes in Serum Analysis for changes in Dehydroepiandrosterone concentration
Time frame: Beginning (Week 1), middle (Week 5), and end of the investigation (Week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor S Finomore, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Float-REST and Nappod in people with Pain, Chronic, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Functional Magnetic Resonance Imaging (fMRI) (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.