Clinical trial NCT03584750: Floating for Chronic Pain
Official title: Floating for Chronic Pain (Float4Pain)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain Syndrome
Keywords: Somatic and psychological factors
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain intensity (maximum and average) as compared to baseline
timeFrame: 1, 12 and 24 weeks after intervention
Secondary outcomes:
measure: Change in Pain scores (maximum and average, dichotomous) as compared to baseline
timeFrame: 1, 12 and 24 weeks after intervention
measure: Change in pain-related disability as compared to baseline
timeFrame: 1, 12 and 24 weeks after intervention
measure: Change in trait anxiety as compared to baseline
timeFrame: 1, 12 and 24 weeks after intervention
measure: Change in depression as compared to baseline
timeFrame: 1, 12 and 24 weeks after intervention
measure: Change in physical and mental health as compared to baseline
timeFrame: 1, 12 and 24 weeks after intervention
measure: Change in quality of sleep assessed by a numeric rating scale as compared to baseline
timeFrame: 1, 12 and 24 weeks after intervention
measure: Change in use of pain medication as compared to baseline
timeFrame: 1, 12 and 24 weeks after intervention
measure: Change in pain area as compared to baseline
timeFrame: 1 week after intervention
measure: Change in pain widespreadness as compared to baseline
timeFrame: 1 week after intervention
measure: Change in pain intensity
timeFrame: Immediately before - immediately after every float session
measure: Change in pain area and widespreadness
timeFrame: Immediately before - immediately after every float session
measure: Change in state anxiety
timeFrame: Immediately before - immediately after every float session
measure: Change in heart rate
timeFrame: Immediately before - immediately after every float session
measure: Change in high frequency (HF) power of heart rate
timeFrame: Immediately before - immediately after every float session
measure: Change in low frequency (LF) power of heart rate
timeFrame: Immediately before - immediately after every float session
measure: Change in the LF/HF ratio of heart rate
timeFrame: Immediately before - immediately after every float session
measure: Change in the standard deviation of NN intervals (SDNN)
timeFrame: Immediately before - immediately after every float session
measure: Change in the root mean square of successive differences (RMSSD)
timeFrame: Immediately before - immediately after every float session
measure: Change in the coefficient of variation (CV)
timeFrame: Immediately before - immediately after every float session
measure: Change in the proportion of NN50 divided by total number of NNs (pNN50)
timeFrame: Immediately before - immediately after every float session
measure: Unusual bodily sensations during floating
timeFrame: During floating
measure: Change in relaxation
timeFrame: Immediately before - immediately after every float session
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Florian Beissner, Dr. phil. nat.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.