Floating for Chronic Pain

Chronic Pain Syndrome Clinical Trial

— Float4Pain  

Official title:

Floating for Chronic Pain (Float4Pain)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584750
• Other study ID #: 7684
• Status: Completed
• Phase: N/A
• Start date: June 26, 2018
• Est. completion date: June 18, 2020

Study information

• Verified date: November 2020
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 18, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome

Intervention

Other:
• Floating
Floating in specialized tank with full floatation and sensory deprivation.
• Placebo floating
Floating in specialized tank with reduced floatation and sensory deprivation.

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1, 12 and 24 weeks after intervention
Secondary	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.	1, 12 and 24 weeks after intervention
Secondary	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).	1, 12 and 24 weeks after intervention
Secondary	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.	1, 12 and 24 weeks after intervention
Secondary	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).	1, 12 and 24 weeks after intervention
Secondary	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.	1, 12 and 24 weeks after intervention
Secondary	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").	1, 12 and 24 weeks after intervention
Secondary	Change in use of pain medication as compared to baseline	Self reported list	1, 12 and 24 weeks after intervention
Secondary	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.	1 week after intervention
Secondary	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).	1 week after intervention
Secondary	Change in pain intensity	Same as Outcome 1, but for acute pain	Immediately before - immediately after every float session
Secondary	Change in pain area and widespreadness	Same as Outcome 9, but for acute pain	Immediately before - immediately after every float session
Secondary	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.	Immediately before - immediately after every float session
Secondary	Change in heart rate	Heart rate [bpm] will be derived from a 5-minute ECG recording. Normative values range between 60 and 90 bpm.	Immediately before - immediately after every float session
Secondary	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.	Immediately before - immediately after every float session
Secondary	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.	Immediately before - immediately after every float session
Secondary	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.	Immediately before - immediately after every float session
Secondary	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.	Immediately before - immediately after every float session
Secondary	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.	Immediately before - immediately after every float session
Secondary	Change in the coefficient of variation (CV)	CV [%] will be derived from a 5-minute ECG recording. Normative values range between 3-12%.	Immediately before - immediately after every float session
Secondary	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%.	Immediately before - immediately after every float session
Secondary	Unusual bodily sensations during floating	Electronic drawing	During floating
Secondary	Change in relaxation	Relaxation will be assessed via numeric rating scale from 0 ("not relaxed at all") to 100 ("completely relaxed").	Immediately before - immediately after every float session