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Trial record 2 of 2 for:    beissner

Floating for Chronic Pain (Float4Pain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03584750
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Beißner, Florian Prof. Dr., Hannover Medical School

Tracking Information
First Submitted Date  ICMJE June 11, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE June 12, 2018
Actual Primary Completion Date January 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
Change in Pain intensity (maximum and average) as compared to baseline [ Time Frame: 1, 12 and 24 weeks after intervention ]
Numeric rating scales from 0 ("no pain") to 100 ("maximum imaginable pain"), assessing retrospectively the week before.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • Change in Pain scores (maximum and average, dichotomous) as compared to baseline [ Time Frame: 1, 12 and 24 weeks after intervention ]
    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.
  • Change in pain-related disability as compared to baseline [ Time Frame: 1, 12 and 24 weeks after intervention ]
    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).
  • Change in trait anxiety as compared to baseline [ Time Frame: 1, 12 and 24 weeks after intervention ]
    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.
  • Change in depression as compared to baseline [ Time Frame: 1, 12 and 24 weeks after intervention ]
    Depression will be assessed via the Becks Depression Inventory (BDI). The total score ranges from 0 (no depression) to 63 (severe depression).
  • Change in physical and mental health as compared to baseline [ Time Frame: 1, 12 and 24 weeks after intervention ]
    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.
  • Change in quality of sleep assessed by a numeric rating scale as compared to baseline [ Time Frame: 1, 12 and 24 weeks after intervention ]
    Participants will be asked how much their pain impairs their sleep on a scale from 0 ("not at all") to 100 ("very much").
  • Change in use of pain medication as compared to baseline [ Time Frame: 1, 12 and 24 weeks after intervention ]
    Self reported list
  • Change in pain area as compared to baseline [ Time Frame: 1 week after intervention ]
    Pain area derived from electronic pain drawings (SymptomMapper). Pain area ranges from 0 to 100% of body area.
  • Change in pain widespreadness as compared to baseline [ Time Frame: 1 week after intervention ]
    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).
  • Change in pain intensity [ Time Frame: Immediately before - immediately after every float session ]
    Same as Outcome 1, but for acute pain
  • Change in pain area and widespreadness [ Time Frame: Immediately before - immediately after every float session ]
    Same as Outcome 9, but for acute pain
  • Change in state anxiety [ Time Frame: Immediately before - immediately after every float session ]
    State anxiety will be assessed via the "State-Trait Anxiety Inventory (STAI) Form X1". Scores range from 20 to 80, with higher scores indicating greater anxiety.
  • Change in heart rate [ Time Frame: Immediately before - immediately after every float session ]
    Heart rate [bpm] will be derived from a 5-minute ECG recording. Normative values range between 60 and 90 bpm.
  • Change in high frequency (HF) power of heart rate [ Time Frame: Immediately before - immediately after every float session ]
    HF power (0.15-0.4 Hz) will be derived from a 5-minute ECG recording. Normative values range between 770-1078 ms^2.
  • Change in low frequency (LF) power of heart rate [ Time Frame: Immediately before - immediately after every float session ]
    LF power (0.04-0.15 Hz) will be derived from a 5-minute ECG recording. Normative values range between 754-1078 ms^2.
  • Change in the LF/HF ratio of heart rate [ Time Frame: Immediately before - immediately after every float session ]
    See outcomes 15 and 16 for LF and HF frequency bands. Normative values range between 1.5-2.
  • Change in the standard deviation of NN intervals (SDNN) [ Time Frame: Immediately before - immediately after every float session ]
    SDNN [ms] will be derived from a 5-minute ECG recording. Normative values range between 30-100 ms.
  • Change in the root mean square of successive differences (RMSSD) [ Time Frame: Immediately before - immediately after every float session ]
    RMSSD [ms] will be derived from a 5-minute ECG recording. Normative values range between 15-45 ms.
  • Change in the coefficient of variation (CV) [ Time Frame: Immediately before - immediately after every float session ]
    CV [%] will be derived from a 5-minute ECG recording. Normative values range between 3-12%.
  • Change in the proportion of NN50 divided by total number of NNs (pNN50) [ Time Frame: Immediately before - immediately after every float session ]
    pNN50 [%] will be derived from a 5-minute ECG recording. Normative values range between 15-34%.
  • Unusual bodily sensations during floating [ Time Frame: During floating ]
    Electronic drawing
  • Change in relaxation [ Time Frame: Immediately before - immediately after every float session ]
    Relaxation will be assessed via numeric rating scale from 0 ("not relaxed at all") to 100 ("completely relaxed").
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Floating for Chronic Pain
Official Title  ICMJE Floating for Chronic Pain (Float4Pain)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain Syndrome
Intervention  ICMJE
  • Other: Floating
    Floating in specialized tank with full floatation and sensory deprivation.
    Other Name: Floatation REST
  • Other: Placebo floating
    Floating in specialized tank with reduced floatation and sensory deprivation.
Study Arms  ICMJE
  • Active Comparator: Intervention group
    Floating
    Intervention: Other: Floating
  • Placebo Comparator: Control group
    Placebo floating
    Intervention: Other: Placebo floating
  • No Intervention: No-treatment group
    Waiting list
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2020)
99
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2018)
75
Actual Study Completion Date  ICMJE June 18, 2020
Actual Primary Completion Date January 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584750
Other Study ID Numbers  ICMJE 7684
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Beißner, Florian Prof. Dr., Hannover Medical School
Study Sponsor  ICMJE Hannover Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Florian Beissner, Dr. phil. nat. Hannover Medical School
PRS Account Hannover Medical School
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP