Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2018-06-26
2020-06-18
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention group
Floating
Floating
Floating in specialized tank with full floatation and sensory deprivation.
Control group
Placebo floating
Placebo floating
Floating in specialized tank with reduced floatation and sensory deprivation.
No-treatment group
Waiting list
No interventions assigned to this group
Interventions
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Floating
Floating in specialized tank with full floatation and sensory deprivation.
Placebo floating
Floating in specialized tank with reduced floatation and sensory deprivation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able and willing to give written informed consent
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Beißner, Florian Prof. Dr.
Principal Investigator
Principal Investigators
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Florian Beissner, Dr. phil. nat.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Hannover Medical School
Hanover, , Germany
Countries
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References
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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.
Other Identifiers
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7684
Identifier Type: -
Identifier Source: org_study_id