Floating for Chronic Pain (Float4Pain)

Floating for Chronic Pain (Float4Pain)

In recent years there has been a novel approach for the treatment of chronic pain: Floatation REST (restricted environmental stimulation therapy). Floating is a therapeutic approach, in which patients float in a specialized pool or tank on water that contains high concentrations of Epsom salt (Magnesium sulfate). Water is kept at skin temperature (35-36°C) and the pool or tank is shielded to provide almost complete darkness and silence. This therapeutic approach has proven to be effective in alleviating chronic pain.

Due to the difficulties associated with designing a credible placebo control there have been no randomized controlled trials (RCTs) with patients blinding so far. Such blinding, however, is crucial, to assess the true therapeutic effect of the intervention.

The investigators will conduct the first patient blinded RCT of Floatation REST for chronic pain with a credible placebo control for floating and a no-treatment group.

Study Overview

• Status: Completed
• Conditions: Chronic Pain Syndrome
• Intervention / Treatment: Other: Floating; Other: Placebo floating

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Hannover Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Current diagnosis of chronic pain disorder with somatic and psychological factors (German ICD F45.41)
• Able and willing to give written informed consent

Exclusion Criteria:

• Pregnant or nursing women (self report)
• Previous experience with floating
• Acute illnesses that may exacerbate or shadow the chronic pain condition (acute inflammation, major depression, active neoplasm, etc.)
• History of alcohol and drug abuse
• Any clinically relevant abnormal findings in the clinical history, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study or the subject's ability to participate in the study.
• Any clinical condition that may prevent the subject from floating, such as: open injuries, contagious diseases (influenza, GI infections, athlete's foot), GERD, epilepsy, claustrophobia, schizophrenia, incontinence or acute skin disorders.
• Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention group; Floating	Other: Floating; Floating in specialized tank with full floatation and sensory deprivation.; Other Names: Floatation REST
PLACEBO_COMPARATOR: Control group; Placebo floating	Other: Placebo floating; Floating in specialized tank with reduced floatation and sensory deprivation.
NO_INTERVENTION: No-treatment group; Waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain intensity (maximum and average) as compared to baseline	Numeric rating scales from 0 ("no pain") to 100 ("maximum imaginable pain"), assessing retrospectively the week before.	1, 12 and 24 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain scores (maximum and average, dichotomous) as compared to baseline	Numeric rating scale from 0 ("no pain") to 100 ("maximum imaginable pain"), assessing retrospectively the week before. A change of 30% or more pain reduction will be considered a success.	1, 12 and 24 weeks after intervention
Change in pain-related disability as compared to baseline	Pain related disability will be assessed via the Pain Disability Index (PDI). The total score ranges from 0 (no pain-related disability) to 70 (maximal disability).	1, 12 and 24 weeks after intervention
Change in trait anxiety as compared to baseline	Trait anxiety will be assessed via the "State-Trait Anxiety Inventory (STAI) Form X2". The total score ranges from 20 to 80, with higher scores indicating greater anxiety.	1, 12 and 24 weeks after intervention
Change in depression as compared to baseline	Depression will be assessed via the Becks Depression Inventory (BDI). The total score ranges from 0 (no depression) to 63 (severe depression).	1, 12 and 24 weeks after intervention
Change in physical and mental health as compared to baseline	This will be assessed via the "12-Item Short Form Survey (SF-12v2)". This questionnaire yields two scores that will be reported separately: Physical Component Summary (PCS) and Mental Component Summary (MCS), both normalised to 50 with a standard deviation of 10. Where values larger than 50 represent better than average health.	1, 12 and 24 weeks after intervention
Change in quality of sleep assessed by a numeric rating scale as compared to baseline	Participants will be asked how much their pain impairs their sleep on a scale from 0 ("not at all") to 100 ("very much").	1, 12 and 24 weeks after intervention
Change in use of pain medication as compared to baseline	Self reported list	1, 12 and 24 weeks after intervention
Change in pain area as compared to baseline	Pain area derived from electronic pain drawings (SymptomMapper). Pain area ranges from 0 to 100% of body area.	1 week after intervention
Change in pain widespreadness as compared to baseline	Widespread pain index (WPI) derived from electronic pain drawings (SymptomMapper). The WPI ranges from 1 (pain localised in one region) to 19 (pain affects all possible regions).	1 week after intervention
Change in pain intensity	Same as Outcome 1, but for acute pain	Immediately before - immediately after every float session
Change in pain area and widespreadness	Same as Outcome 9, but for acute pain	Immediately before - immediately after every float session
Change in state anxiety	State anxiety will be assessed via the "State-Trait Anxiety Inventory (STAI) Form X1". Scores range from 20 to 80, with higher scores indicating greater anxiety.	Immediately before - immediately after every float session
Change in heart rate	Heart rate [bpm] will be derived from a 5-minute ECG recording. Normative values range between 60 and 90 bpm.	Immediately before - immediately after every float session
Change in high frequency (HF) power of heart rate	HF power (0.15-0.4 Hz) will be derived from a 5-minute ECG recording. Normative values range between 770-1078 ms^2.	Immediately before - immediately after every float session
Change in low frequency (LF) power of heart rate	LF power (0.04-0.15 Hz) will be derived from a 5-minute ECG recording. Normative values range between 754-1078 ms^2.	Immediately before - immediately after every float session
Change in the LF/HF ratio of heart rate	See outcomes 15 and 16 for LF and HF frequency bands. Normative values range between 1.5-2.	Immediately before - immediately after every float session
Change in the standard deviation of NN intervals (SDNN)	SDNN [ms] will be derived from a 5-minute ECG recording. Normative values range between 30-100 ms.	Immediately before - immediately after every float session
Change in the root mean square of successive differences (RMSSD)	RMSSD [ms] will be derived from a 5-minute ECG recording. Normative values range between 15-45 ms.	Immediately before - immediately after every float session
Change in the coefficient of variation (CV)	CV [%] will be derived from a 5-minute ECG recording. Normative values range between 3-12%.	Immediately before - immediately after every float session
Change in the proportion of NN50 divided by total number of NNs (pNN50)	pNN50 [%] will be derived from a 5-minute ECG recording. Normative values range between 15-34%.	Immediately before - immediately after every float session
Unusual bodily sensations during floating	Electronic drawing	During floating
Change in relaxation	Relaxation will be assessed via numeric rating scale from 0 ("not relaxed at all") to 100 ("completely relaxed").	Immediately before - immediately after every float session

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Florian Beissner, Dr. phil. nat., Hannover Medical School

Publications and helpful links

General Publications

• Loose LF, Manuel J, Karst M, Schmidt LK, Beissner F. Flotation Restricted Environmental Stimulation Therapy for Chronic Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 May 3;4(5):e219627. doi: 10.1001/jamanetworkopen.2021.9627.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2018
• Primary Completion (ACTUAL): January 2, 2020
• Study Completion (ACTUAL): June 18, 2020

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (ACTUAL): July 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Somatic and psychological factors
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 7684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No