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Completed

NCT Number: NCT03584750

Floating for Chronic Pain

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.

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Key information

Conditions

Chronic Pain Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Floating

Other

Floating in specialized tank with full floatation and sensory deprivation.

Other names: Floatation REST

Placebo floating

Other

Floating in specialized tank with reduced floatation and sensory deprivation.

Primary outcomes

  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 outcomes

  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").

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

Floating for Chronic Pain (Float4Pain)

Acronym: Float4Pain

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2018
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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