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Floating for Chronic Pain (Float4Pain)

Primary Purpose

Chronic Pain Syndrome

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Floating

Placebo floating

About this trial

This is an interventional treatment trial for Chronic Pain Syndrome focused on measuring Somatic and psychological factors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hannover Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Intervention group

Control group

No-treatment group

Arm Description

Floating

Placebo floating

Waiting list

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

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

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

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

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

Self reported list

Change in pain area as compared to baseline

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

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

Same as Outcome 1, but for acute pain

Change in pain area and widespreadness

Same as Outcome 9, but for acute pain

Change in state anxiety

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

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

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

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

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)

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)

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)

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)

pNN50 [%] will be derived from a 5-minute ECG recording. Normative values range between 15-34%.

Unusual bodily sensations during floating

Electronic drawing

Change in relaxation

Relaxation will be assessed via numeric rating scale from 0 ("not relaxed at all") to 100 ("completely relaxed").

Full Information

NCT ID

NCT03584750

First Posted

June 11, 2018

Last Updated

November 23, 2020

Sponsor

Hannover Medical School

1. Study Identification

Unique Protocol Identification Number

NCT03584750

Brief Title

Floating for Chronic Pain

Acronym

Float4Pain

Official Title

Floating for Chronic Pain (Float4Pain)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

June 26, 2018 (Actual)

Primary Completion Date

January 2, 2020 (Actual)

Study Completion Date

June 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hannover Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain Syndrome

Keywords

Somatic and psychological factors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Active Comparator

Arm Description

Floating

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Placebo floating

Arm Title

No-treatment group

Arm Type

No Intervention

Arm Description

Waiting list

Intervention Type

Other

Intervention Name(s)

Floating

Other Intervention Name(s)

Floatation REST

Intervention Description

Floating in specialized tank with full floatation and sensory deprivation.

Intervention Type

Other

Intervention Name(s)

Placebo floating

Intervention Description

Floating in specialized tank with reduced floatation and sensory deprivation.

Primary Outcome Measure Information:

Title

Change in Pain intensity (maximum and average) as compared to baseline

Description

Numeric rating scales from 0 ("no pain") to 100 ("maximum imaginable pain"), assessing retrospectively the week before.

Time Frame

1, 12 and 24 weeks after intervention

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

1, 12 and 24 weeks after intervention

Title

Change in pain-related disability as compared to baseline

Description

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).

Time Frame

1, 12 and 24 weeks after intervention

Title

Change in trait anxiety as compared to baseline

Description

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.

Time Frame

1, 12 and 24 weeks after intervention

Title

Change in depression as compared to baseline

Description

Depression will be assessed via the Becks Depression Inventory (BDI). The total score ranges from 0 (no depression) to 63 (severe depression).

Time Frame

1, 12 and 24 weeks after intervention

Title

Change in physical and mental health as compared to baseline

Description

Time Frame

1, 12 and 24 weeks after intervention

Title

Change in quality of sleep assessed by a numeric rating scale as compared to baseline

Description

Participants will be asked how much their pain impairs their sleep on a scale from 0 ("not at all") to 100 ("very much").

Time Frame

1, 12 and 24 weeks after intervention

Title

Change in use of pain medication as compared to baseline

Description

Self reported list

Time Frame

1, 12 and 24 weeks after intervention

Title

Change in pain area as compared to baseline

Description

Pain area derived from electronic pain drawings (SymptomMapper). Pain area ranges from 0 to 100% of body area.

Time Frame

1 week after intervention

Title

Change in pain widespreadness as compared to baseline

Description

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).

Time Frame

1 week after intervention

Title

Change in pain intensity

Description

Same as Outcome 1, but for acute pain

Time Frame

Immediately before - immediately after every float session

Title

Change in pain area and widespreadness

Description

Same as Outcome 9, but for acute pain

Time Frame

Immediately before - immediately after every float session

Title

Change in state anxiety

Description

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.

Time Frame

Immediately before - immediately after every float session

Title

Change in heart rate

Description

Heart rate [bpm] will be derived from a 5-minute ECG recording. Normative values range between 60 and 90 bpm.

Time Frame

Immediately before - immediately after every float session

Title

Change in high frequency (HF) power of heart rate

Description

HF power (0.15-0.4 Hz) will be derived from a 5-minute ECG recording. Normative values range between 770-1078 ms^2.

Time Frame

Immediately before - immediately after every float session

Title

Change in low frequency (LF) power of heart rate

Description

LF power (0.04-0.15 Hz) will be derived from a 5-minute ECG recording. Normative values range between 754-1078 ms^2.

Time Frame

Immediately before - immediately after every float session

Title

Change in the LF/HF ratio of heart rate

Description

See outcomes 15 and 16 for LF and HF frequency bands. Normative values range between 1.5-2.

Time Frame

Immediately before - immediately after every float session

Title

Change in the standard deviation of NN intervals (SDNN)

Description

SDNN [ms] will be derived from a 5-minute ECG recording. Normative values range between 30-100 ms.

Time Frame

Immediately before - immediately after every float session

Title

Change in the root mean square of successive differences (RMSSD)

Description

RMSSD [ms] will be derived from a 5-minute ECG recording. Normative values range between 15-45 ms.

Time Frame

Immediately before - immediately after every float session

Title

Change in the coefficient of variation (CV)

Description

CV [%] will be derived from a 5-minute ECG recording. Normative values range between 3-12%.

Time Frame

Immediately before - immediately after every float session

Title

Change in the proportion of NN50 divided by total number of NNs (pNN50)

Description

pNN50 [%] will be derived from a 5-minute ECG recording. Normative values range between 15-34%.

Time Frame

Immediately before - immediately after every float session

Title

Unusual bodily sensations during floating

Description

Electronic drawing

Time Frame

During floating

Title

Change in relaxation

Description

Relaxation will be assessed via numeric rating scale from 0 ("not relaxed at all") to 100 ("completely relaxed").

Time Frame

Immediately before - immediately after every float session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florian Beissner, Dr. phil. nat.

Organizational Affiliation

Hannover Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hannover Medical School

City

Hannover

ZIP/Postal Code

30625

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33988708

Citation

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.

Results Reference

derived

Learn more about this trial

Floating for Chronic Pain

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