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Floating for Chronic Pain (Float4Pain)

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ClinicalTrials.gov Identifier: NCT03584750
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Beißner, Florian Prof. Dr., Hannover Medical School

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Syndrome Other: Floating Other: Placebo floating Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Floating for Chronic Pain (Float4Pain)
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Intervention group
Floating
Other: Floating
Floating in specialized tank with full floatation and sensory deprivation.
Other Name: Floatation REST

Placebo Comparator: Control group
Placebo floating
Other: Placebo floating
Floating in specialized tank with reduced floatation and sensory deprivation.

No Intervention: No-treatment group
Waiting list



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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.

  6. 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").

  7. Change in use of pain medication as compared to baseline [ Time Frame: 1, 12 and 24 weeks after intervention ]
    Self reported list

  8. 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.

  9. 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).

  10. Change in pain intensity [ Time Frame: Immediately before - immediately after every float session ]
    Same as Outcome 1, but for acute pain

  11. Change in pain area and widespreadness [ Time Frame: Immediately before - immediately after every float session ]
    Same as Outcome 9, but for acute pain

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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%.

  20. 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%.

  21. Unusual bodily sensations during floating [ Time Frame: During floating ]
    Electronic drawing

  22. 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").



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584750


Contacts
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Contact: Jorge Manuel, M. Sc. +49 511 5350 ext 8413 ManuelSanchez.Jorge@mh-hannover.de

Locations
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Germany
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Jorge Manuel, M. Sc.    +49-511-5350 ext 8315    ManuelSanchez.Jorge@mh-hannover.de   
Sponsors and Collaborators
Hannover Medical School
Investigators
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Principal Investigator: Florian Beissner, Dr. phil. nat. Hannover Medical School

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Responsible Party: Beißner, Florian Prof. Dr., Principal Investigator, Hannover Medical School
ClinicalTrials.gov Identifier: NCT03584750     History of Changes
Other Study ID Numbers: 7684
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beißner, Florian Prof. Dr., Hannover Medical School:
Somatic and psychological factors
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms