Floating for Chronic Pain

Study Overview
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Brief Summary
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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.

Official Title
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Floating for Chronic Pain (Float4Pain)

Conditions
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Chronic Pain Syndrome

Intervention / Treatment
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* Other: Floating
* Other: Placebo floating


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Floating | Other: Floating<br>* Floating in specialized tank with full floatation and sensory deprivation.<br>* Other names: Floatation REST;|
| Placebo Comparator: Control group<br>Placebo floating | Other: Placebo floating<br>* Floating in specialized tank with reduced floatation and sensory deprivation.<br>|
| No Intervention: No-treatment group<br>Waiting list | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Somatic and psychological factors