An interventional study of serial whole body hyperthermia in Hyperthermia, Chronic Primary Pain and Widespread Pain, sponsored by Bern University of Applied Sciences. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Bern University of Applied Sciences · Not applicable, Interventional, and Treatment
This study, in a quasi-experimental matched two-group pre-post design, investigates the effect of serial water-filtered whole-body hyperthermia on circadian core body temperature, the somatosensory system (nociception) and the movement evoked pain 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.
For women of childbearing potential, four measurements of circadian core body temperature are also taken during the pre-trial phase to monitor menstrual cycle variability and to correct for it in the main trial. To correctly determine menstrual cycle phases, blood samples to assess the levels of sex hormones, LH urine tests, and basal body temperature are collected.
256 studies on the registry are indexed under Hyperthermia; 73 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 232 interventional studies indexed under Hyperthermia.
Browse Hyperthermia studies →Bern University of Applied Sciences is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
patients:
healthy:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For the study, the method of water-filtered whole-body hyperthermia is used. The HT 3000 system (by heckel medizintechnik GmbH, Olgastrasse 25, 73728 Esslingen, Garmany) is used, in which the entire body is heated to a core body temperature above the physiological 37°C. The aim is to achieve a core body temperature of 38.5°C within the framework of mild whole-body hyperthermia. After this warm-up phase, a temperature plateau phase of about 15 minutes follows, in which an attempt is made to maintain the core body temperature of 38.5°C. In the temperature plateau phase, a slight increase in the body core temperature is usually observed. The total time required for a session is given as 2.5 to 3 hours, but this depends on the individual constitution and daily condition of the patient and can be subject to fluctuations.
Behavioral: serial whole body hyperthermia
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.
Also known as: passive whole body hyperthermia, water filtered whole body hyperthermia, moderate whole body infrared-A hyperthermia
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
Fear Avoidance Beliefs Questionnaire (FABQ)
Is a psychological questionnaire designed to assess a person's beliefs about how physical activity and work may influence their pain. It focuses on fear-avoidance behaviours, particularly in individuals with musculoskeletal pain (e.g., low back pain). The questionnaire consists of 16 items divided into two subscales: physical activity (FABQ-PA) and work (FABQ-W). Items are rated on a 7-point Likert scale (from "completely disagree" to "completely agree").
Time frame: Week 0
Fear Avoidance Beliefs Questionnaire (FABQ)
Is a psychological questionnaire designed to assess a person's beliefs about how physical activity and work may influence their pain. It focuses on fear-avoidance behaviours, particularly in individuals with musculoskeletal pain (e.g., low back pain). The questionnaire consists of 16 items divided into two subscales: physical activity (FABQ-PA) and work (FABQ-W). Items are rated on a 7-point Likert scale (from "completely disagree" to "completely agree").
Time frame: Week 5
Fear Avoidance Beliefs Questionnaire (FABQ)
Is a psychological questionnaire designed to assess a person's beliefs about how physical activity and work may influence their pain. It focuses on fear-avoidance behaviours, particularly in individuals with musculoskeletal pain (e.g., low back pain). The questionnaire consists of 16 items divided into two subscales: physical activity (FABQ-PA) and work (FABQ-W). Items are rated on a 7-point Likert scale (from "completely disagree" to "completely agree").
Time frame: Week 12
Fear Avoidance Beliefs Questionnaire (FABQ)
Is a psychological questionnaire designed to assess a person's beliefs about how physical activity and work may influence their pain. It focuses on fear-avoidance behaviours, particularly in individuals with musculoskeletal pain (e.g., low back pain). The questionnaire consists of 16 items divided into two subscales: physical activity (FABQ-PA) and work (FABQ-W). Items are rated on a 7-point Likert scale (from "completely disagree" to "completely 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
Avoidance-Endurance Fast-Screen (AEFS)
Description: Is a short screening questionnaire designed to identify maladaptive pain coping patterns, specifically avoidance and endurance behaviours in individuals with musculoskeletal pain. It differentiates between fear-avoidance responses and endurance-related coping styles (e.g., persistence despite pain). The AEFS includes a 7-point scale (0=never to 6=always) for Pain Persistence (PPS) from the Avoidance-Endurance Questionnaire (AEQ), as well as two dichotomous (0=yes, 1=no) mood items from the Beck-Depressions-Inventar. The PPS scale is administered using two response scales for coping with mild and severe pain.
Time frame: week 0
Avoidance-Endurance Fast-Screen (AEFS)
Description: Is a short screening questionnaire designed to identify maladaptive pain coping patterns, specifically avoidance and endurance behaviours in individuals with musculoskeletal pain. It differentiates between fear-avoidance responses and endurance-related coping styles (e.g., persistence despite pain). The AEFS includes a 7-point scale (0=never to 6=always) for Pain Persistence (PPS) from the Avoidance-Endurance Questionnaire (AEQ), as well as two dichotomous (0=yes, 1=no) mood items from the Beck-Depressions-Inventar. The PPS scale is administered using two response scales for coping with mild and severe pain.
Time frame: week 5
Avoidance-Endurance Fast-Screen (AEFS)
Description: Is a short screening questionnaire designed to identify maladaptive pain coping patterns, specifically avoidance and endurance behaviours in individuals with musculoskeletal pain. It differentiates between fear-avoidance responses and endurance-related coping styles (e.g., persistence despite pain). The AEFS includes a 7-point scale (0=never to 6=always) for Pain Persistence (PPS) from the Avoidance-Endurance Questionnaire (AEQ), as well as two dichotomous (0=yes, 1=no) mood items from the Beck-Depressions-Inventar. The PPS scale is administered using two response scales for coping with mild and severe pain.
Time frame: week 12
Avoidance-Endurance Fast-Screen (AEFS)
Description: Is a short screening questionnaire designed to identify maladaptive pain coping patterns, specifically avoidance and endurance behaviours in individuals with musculoskeletal pain. It differentiates between fear-avoidance responses and endurance-related coping styles (e.g., persistence despite pain). The AEFS includes a 7-point scale (0=never to 6=always) for Pain Persistence (PPS) from the Avoidance-Endurance Questionnaire (AEQ), as well as two dichotomous (0=yes, 1=no) mood items from the Beck-Depressions-Inventar. The PPS scale is administered using two response scales for coping with mild and severe pain.
Time frame: week 30
BDNF
Brain-Derived Neurotrophic Factor (BDNF) in blood to measure nociplasticity
Time frame: Week 0
BDNF
Brain-Derived Neurotrophic Factor (BDNF) in blood to measure nociplasticity
Time frame: Week 5
PRISE (Patient-Rated Inventory of Side Effects)
A tool used to assess the presence and severity of side effects (0=no severity, 3= greater severity) across nine organ/function domains, including gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual function, and other areas
Time frame: 30min post treatment
PSST
The Premenstrual Symptoms Screening Tool (PSST) is used to assess the presence and severity of premenstrual symptoms and their impact on daily functioning. The tool translates categorical criteria into a rating scale. It consists of 19 items: 14 items regarding premenstrual symptoms and 5 items measuring functional impairment. Each item is rated on a 4-point Likert scale (0 = not at all, 1 = mild, 2 = moderate, 3 = severe). The total score is used to screen for Premenstrual Dysphoric Disorder (PMDD) and moderate-to-severe Premenstrual Syndrome (PMS), with higher ratings reflecting a higher symptom severity.
Time frame: During the pre-trial phase, specifically on day 2 after ovulation (luteal phase)
Plan to share: No
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Bern University of Applied Sciences