Floating for Chronic Pain

Hannover Medical School99 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Pain Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 1, 12 and 24 weeks after intervention

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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").

Time frame: 1, 12 and 24 weeks after intervention

Change in use of pain medication as compared to baseline

Self reported list

Time frame: 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.

Time frame: 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).

Time frame: 1 week after intervention

Change in pain intensity

Same as Outcome 1, but for acute pain