Floating for Chronic Pain

NCT03584750 | Completed

• 1 other identifier: 7684
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain Syndrome

Keywords

Somatic and psychological factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Change in Pain scores (maximum and average, dichotomous) as compared to baseline

  1, 12 and 24 weeks after intervention

• Change in pain-related disability as compared to baseline

  1, 12 and 24 weeks after intervention

• Change in trait anxiety as compared to baseline

  1, 12 and 24 weeks after intervention

• Change in depression as compared to baseline

  1, 12 and 24 weeks after intervention

• Change in physical and mental health as compared to baseline

  1, 12 and 24 weeks after intervention

Study Arms (3)

Intervention group

ACTIVE COMPARATOR

Floating

Other: Floating

Control group

PLACEBO COMPARATOR

Placebo floating

Other: Placebo floating

No-treatment group

NO INTERVENTION

Waiting list

Interventions

Floating OTHER

Floating in specialized tank with full floatation and sensory deprivation.

Also known as: Floatation REST

Intervention group

Placebo floating OTHER

Floating in specialized tank with reduced floatation and sensory deprivation.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (1)

• 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.

  PMID: 33988708 DERIVED

MeSH Terms

Interventions

Divorce

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Florian Beissner, Dr. phil. nat.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 12, 2018
• Study Start: June 26, 2018
• Primary Completion: January 2, 2020
• Study Completion: June 18, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

DE (1)