Floating for Chronic Pain (Float4Pain)

Hannover Medical School (MHH)

Status: Completed

Conditions: Chronic Pain Syndrome

Treatments: Other: Placebo floating; Other: Floating

Study type: Interventional

Funder types: Other

Identifiers

NCT03584750

7684

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 3 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

Floating

Treatment:

Other: Floating

Control group

Placebo Comparator group

Description:

Placebo floating

Treatment:

Other: Placebo floating

No-treatment group

No Intervention group

Description:

Waiting list