This study, in a quasi-experimental pre-post design, investigates the effect of serial water-filtered whole-body hyperthermia on circadian core body temperature, the somatosensory system (nociception) and pain perception in healthy and patients with chronic primary pain (e.g., fibromyalgia). The intervention lasts 3 weeks with two treatment sessions per week.
A total of 30 healthy participants and 30 participants with chronic primary pain between the ages of 18 and 70 are being sought. All participants will receive the same amount of water-filtered whole-body hyperthermia in outpatient or semi-inpatient treatment. All abnormalities and side effects will be documented by the responsible therapists and doctors. Changes in circadian core body temperature, sensory or nociceptive sensitivities of the somatosensory system, and movement-evoked pain will be recorded, and blood parameters for nociceptive plasticity will be collected. For secondary efficacy, specific questionnaires on pain experience, fatigue, depression, and fear avoidance behavior will be collected 7 and 25 weeks after therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The hyperthermia treatment is carried out in a cycle of two treatments per week, with at least one day in between, over a period of three weeks, according to the manufacturer's instructions. According to the guidelines, the rectal (possibly vaginal) temperature (as body core temperature), heart rate and oxygen saturation (Sp02) are continuously determined during the hyperthermiatreatment. During the treatment, continuous supervision by trained personnel is guaranteed, and a doctor is on call.
Bern University of Applied Science
Bern, Canton of Bern, Switzerland
Circadian core body temperature
A BodyCap HF (high-frequency) measurement capsule is used for circadian monitoring of core body temperature over a 24-hour period. The single-use capsule is swallowed and excreted naturally after the measurement.
Time frame: Week 0
Circadian core body temperature
A BodyCap HF (high-frequency) measurement capsule is used for circadian monitoring of core body temperature over a 24-hour period. The single-use capsule is swallowed and excreted naturally after the measurement.
Time frame: Week 5
Cold detection threshold (CDT); °C
CDT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated cold temperature stimuli (Thermode) 3x applied to the skin. Z-values are calculate.
Time frame: Week 0
Cold detection threshold (CDT); °C
CDT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated cold temperature stimuli (Thermode) 3x applied to the skin. Z-values are calculate.
Time frame: week 5
Warm detection threshold (WDT); °C
WDT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated warm temperature stimuli (Thermode) 3x applied to the skin. Z-values are calculate.
Time frame: Week 0
Warm detection threshold (WDT); °C
WDT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated warm temperature stimuli (Thermode) 3x applied to the skin. Z-values are calculate.
Time frame: week 5
Thermal sensory limen (TSL) ; °C
TSL is a part of quantitative sensory testing. A psychophysical testing method in which calibrated warm and cold temperature stimuli (Thermode) alternately 6x applied to the skin. Z-values are calculate and count number of cold stimuli that are perceived as hot.
Time frame: week 0
Thermal sensory limen (TSL) ; °C
TSL is a part of quantitative sensory testing. A psychophysical testing method in which calibrated warm and cold temperature stimuli (Thermode) alternately 6x applied to the skin. Z-values are calculate and count number of cold stimuli that are perceived as hot.
Time frame: week 5
Cold pain threshold (CPT); °C
CPT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated nociceptive cold temperature stimuli (Thermode) 3x applied to the skin. Z-values are calculate.
Time frame: week 0
Cold pain threshold (CPT); °C
CPT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated nociceptive cold temperature stimuli (Thermode) 3x applied to the skin. Z-values are calculate.
Time frame: week 5
Heat pain threshold (HPT); °C
HPT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated nociceptive heat temperature stimuli (Thermode) 3x applied to the skin. Z-values are calculate.
Time frame: week 0
Heat pain threshold (HPT); °C
HPT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated nociceptive heat temperature stimuli (Thermode) 3x applied to the skin. Z-values are calculate.
Time frame: week 5
Mechanical detection threshold (MDT) ; mN
MDT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (different strengths Frey filaments) 10x applied to the skin Z-values are calculated.
Time frame: week 0
Mechanical detection threshold (MDT) ; mN
MDT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (different strengths Frey filaments) 10x applied to the skin Z-values are calculated.
Time frame: week 5
Mechanical pain threshold (MPT), count of sharp and blunt stimuli
MPT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (PinPrick with different weights) 10x applied to the skin. Mechanical pain threshold (MPT). Count number of sharp and blunt stimuli. Z-values are calculated.
Time frame: week 0
Mechanical pain threshold (MPT), count of sharp and blunt stimuli
MPT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (PinPrick with different weights) 10x applied to the skin. Mechanical pain threshold (MPT). Count number of sharp and blunt stimuli. Z-values are calculated.
Time frame: week 5
Mechanical pain sensitivity (MPS) ; NRS
MPS is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (PinPrick with different weights) 35x applied to the skin. The Numeric Rating Scale (0 = no pain to 100 = worst pain imaginable) is queried. Z-values are calculated.
Time frame: week 0
Mechanical pain sensitivity (MPS) ; NRS
MPS is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (PinPrick with different weights) 35x applied to the skin. The Numeric Rating Scale (0 = no pain to 100 = worst pain imaginable) is queried. Z-values are calculated.
Time frame: week 5
Summative pain amplification (WUR); NRS
WUR (wind-up ratio) is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (PinPrick with different weights) single and seriell 10x applied to the skin. The Numeric Rating Scale (0 = no pain to 100 = worst pain imaginable) for single and seriell stimuli are compared into relation. Z-values are calculated.
Time frame: week 0
Summative pain amplification (WUR); NRS
WUR (wind-up ratio) is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (PinPrick with different weights) single and seriell 10x applied to the skin. The Numeric Rating Scale (0 = no pain to 100 = worst pain imaginable) for single and seriell stimuli are compared into relation. Z-values are calculated.
Time frame: week 5
Vibration detection threshold (VDT) ; x/8
VDT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (64Hz tuning fork) 3x applied to the skin. The x/8 vibration is measure (0/8 no perception and 8/8 strengthest perception). Z-values are calculated.
Time frame: week 0
Vibration detection threshold (VDT) ; x/8
VDT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (64Hz tuning fork) 3x applied to the skin. The x/8 vibration is measure (0/8 no perception and 8/8 strengthest perception). Z-values are calculated.
Time frame: week 5
Pressure pain threshold (PPT), kgf/1cm2
PPT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (pain pressure algometer) 5x applied to the skin. Z-values are calculated.
Time frame: week 0
Pressure pain threshold (PPT), kgf/1cm2
PPT is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (pain pressure algometer) 5x applied to the skin. Z-values are calculated.
Time frame: week 5
Dynamic mechanical allodynia (DMA), NRS
DMA is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (brush, cotton wool and Q-Tip) 5x applied to the skin. Z-values are calculated. The Numeric Rating Scale (0 = no pain to 100 = worst pain imaginable) ist queried. Z-values are calculated.
Time frame: week 0
Dynamic mechanical allodynia (DMA), NRS
DMA is a part of quantitative sensory testing. A psychophysical testing method in which calibrated mechanical stimuli (brush, cotton wool and Q-Tip) 5x applied to the skin. Z-values are calculated. The Numeric Rating Scale (0 = no pain to 100 = worst pain imaginable) ist queried. Z-values are calculated.
Time frame: week 5
6-Minute Walk Test (6MWT)
Walking back and forth as far as possible along a 30-meter corridor in 6 minutes, taking breaks as needed ( total distance covered is recorded in meters, pain is measured before and after the test, 0 = no pain, 10 = worst pain imaginable)
Time frame: Week 0
6-Minute Walk Test (6MWT)
Walking back and forth as far as possible along a 30-meter corridor in 6 minutes, taking breaks as needed ( total distance covered is recorded in meters, pain is measured before and after the test, 0 = no pain, 10 = worst pain imaginable)
Time frame: Week 5
McGill Pain Questionnaire (MPQ)
The instrument assesses subjective pain experience and evaluates both the quality and numerical intensity of pain (0 = no pain; 10 = worst pain imaginable)
Time frame: Week 0
McGill Pain Questionnaire (MPQ)
The instrument assesses subjective pain experience and evaluates both the quality and numerical intensity of pain (0 = no pain; 10 = worst pain imaginable)
Time frame: Week 5
McGill Pain Questionnaire (MPQ)
The instrument assesses subjective pain experience and evaluates both the quality and numerical intensity of pain (0 = no pain; 10 = worst pain imaginable)
Time frame: Week 12
McGill Pain Questionnaire (MPQ)
The instrument assesses subjective pain experience and evaluates both the quality and numerical intensity of pain (0 = no pain; 10 = worst pain imaginable)
Time frame: Week 30
TAMPA-Scale (Kinesiophobia)
Is a psychological questionnaire designed to measure a person's fear of movement and (re)injury due to physical activity. 17 items on a 4-point Likert scale (from "strongly disagree" to "strongly agree
Time frame: Week 0
TAMPA-Scale (Kinesiophobia)
Is a psychological questionnaire designed to measure a person's fear of movement and (re)injury due to physical activity. 17 items on a 4-point Likert scale (from "strongly disagree" to "strongly agree
Time frame: Week 5
TAMPA-Scale (Kinesiophobia)
Is a psychological questionnaire designed to measure a person's fear of movement and (re)injury due to physical activity. 17 items on a 4-point Likert scale (from "strongly disagree" to "strongly agree
Time frame: Week 12
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TAMPA-Scale (Kinesiophobia)
Is a psychological questionnaire designed to measure a person's fear of movement and (re)injury due to physical activity. 17 items on a 4-point Likert scale (from "strongly disagree" to "strongly agree
Time frame: Week 30
Multidimensional Fatigue Inventory (MFI-20)
An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue)
Time frame: Week 0
Multidimensional Fatigue Inventory (MFI-20)
An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue)
Time frame: Week 5
Multidimensional Fatigue Inventory (MFI-20)
An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue)
Time frame: Week 12
Multidimensional Fatigue Inventory (MFI-20)
An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue)
Time frame: Week 30
General Depression Scale (ADS-L)
is a german self-report questionnaire designed to assess depressive symptoms in the general population adapted from the CES-D. (20 items, 4-point Likert scale (0 = rarely or none of the time, 3 = most or all of the time)
Time frame: Week 0
General Depression Scale (ADS-L)
is a german self-report questionnaire designed to assess depressive symptoms in the general population adapted from the CES-D. (20 items, 4-point Likert scale (0 = rarely or none of the time, 3 = most or all of the time)
Time frame: Week 5
General Depression Scale (ADS-L)
is a german self-report questionnaire designed to assess depressive symptoms in the general population adapted from the CES-D. (20 items, 4-point Likert scale (0 = rarely or none of the time, 3 = most or all of the time)
Time frame: Week 12
General Depression Scale (ADS-L)
is a german self-report questionnaire designed to assess depressive symptoms in the general population adapted from the CES-D. (20 items, 4-point Likert scale (0 = rarely or none of the time, 3 = most or all of the time)
Time frame: Week 30