HyperthermiaHYPPRI-1NCT07101978
Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain
A study testing serial whole body hyperthermia in people with Hyperthermia and Chronic Primary Pain, run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia, Chronic Primary Pain, Widespread Pain
- What is being tested?
- serial whole body hyperthermia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients:
- Confirmed diagnosis of widespread pain (ICD-11 MG30.01)
- Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) scale ≥ 5 or WPI) ≥ 3 and SS ≥ 9,
- Pain >= 3 month and VAS >= 4,0
- Body - infrared-A-Bulb Distance < 38cm (overweight participants)
- Signed declaration of consent
Show all 12Show fewer
- healthy:
- No chronic illnesses
- No acute infections
- No regular medication: To avoid interactions
- BMI ≤ 40kg/cm2
- Mental health: No psychiatric diagnoses or psychotropic medication in your medical history
Who cannot join
- Participation in other clinical studies
- Contraindications for hyperthermia (severe cardiovascular diseases, tumour diseases, acute infections, pregnant and breastfeeding women)
- Acute and / or feverish microbial infections
- Participants with severe somatic, rheumatic concomitant endocrine or neurological diseases, in particular neurological diseases associated with cognitive disorders, severe liver or kidney and cardiac diseases
- participants who are permanently treated with opioids, cannabis, immunosuppressive drugs (e.g. corticoids, immunosuppressants) or alpha/beta-A(nta)gonists due to a disease from the group described above
- participants with pain due to a serious psychiatric illness (bipolar disorder, psychosis, personality disorder, severe depression, substance abuse) and serious systemic or neurological disorders
- pregnancy or breastfeeding (for women)
- Intake of medication within 6 weeks that inhibits the reuptake of the neurotransmitter serotonin or binds to receptors of this neurotransmitter group
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Bern University of Applied Science
Bern, Canton of Bern, 3012
Kay-Uwe Hanusch, Dr.scient.med, +41 31 848 5005, kay.hanusch@bfh.ch
About this study
Official title: Hyperthermia in Healthy and Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System, Movement Evoked Pain (HYPPRI-1)
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.
Read the detailed description
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.
- Conditions
- Hyperthermia, Chronic Primary Pain, Widespread Pain, Muscular Disease, Rheumatic Diseases, Musculoskeletal Diseases
- Being tested
- serial whole body hyperthermia
- Keywords
- hyperthermia, widespread pain, chronic primary pain, circadian body temperature, quantitative sensory testing, healthy
- Medical subject headings
- Hyperthermia, Chronic Pain, Muscular Diseases, Rheumatic Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Fibromyalgia, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serial whole body hyperthermiaBehavioural
Also called passive whole body hyperthermia, water filtered whole body hyperthermia, moderate whole body infrared-A 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.
| Study group | Role | What they receive |
|---|---|---|
| serial whole body hyperthermia | Experimental | 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. Receives: Behavioral: serial whole body hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Week 5
Secondary outcomes (20)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Dec 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental, matched two group pre-post study design with a healthy and a patients group with the the same intervention
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. med. h.c Erwin Braun Stiftung
- Responsible party
- Principal investigator, Kay-Uwe Hanusch, Bern University of Applied Sciences
- Investigators
- Kay-Uwe Hanusch, Dr.scient.med, Study director, Bern University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101978
- Sponsor's protocol ID
- F.016677-42-PHYW-1
- Acronym
- HYPPRI-1
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperthermia in Healthy and Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System, Movement Evoked Pain (HYPPRI-1)
- ClinicalTrials.gov ID
- NCT07101978
- Acronym / sponsor ID
- HYPPRI-1 / F.016677-42-PHYW-1
- Conditions
- Hyperthermia, Chronic Primary Pain, Widespread Pain, Muscular Disease, Rheumatic Diseases, Musculoskeletal Diseases
- Keywords
- hyperthermia, widespread pain, chronic primary pain, circadian body temperature, quantitative sensory testing, healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Collaborators
- Dr. med. h.c Erwin Braun Stiftung
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental, matched two group pre-post study design with a healthy and a patients group with the the same intervention
| Arm | Type | Receives |
|---|---|---|
| serial whole body hyperthermia | Experimental | Behavioral: serial whole body hyperthermiaFor 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Confirmed diagnosis of widespread pain (ICD-11 MG30.01)
- Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) scale ≥ 5 or WPI) ≥ 3 and SS ≥ 9,
- Pain >= 3 month and VAS >= 4,0
- Body - infrared-A-Bulb Distance < 38cm (overweight participants)
- Signed declaration of consent
Key exclusion criteria (8 listed)
- Participation in other clinical studies
- Contraindications for hyperthermia (severe cardiovascular diseases, tumour diseases, acute infections, pregnant and breastfeeding women)
- Acute and / or feverish microbial infections
- Participants with severe somatic, rheumatic concomitant endocrine or neurological diseases, in particular neurological diseases associated with cognitive disorders, severe liver or kidney and cardiac diseases
- participants who are permanently treated with opioids, cannabis, immunosuppressive drugs (e.g. corticoids, immunosuppressants) or alpha/beta-A(nta)gonists due to a disease from the group described above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serial whole body hyperthermiaAlso: passive whole body hyperthermia, water filtered whole body hyperthermia, moderate whole body infrared-A hyperthermiaThe 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. | Behavioural | serial whole body hyperthermia |
Primary outcome
Circadian core body temperature
Time frame: Week 0
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.
Circadian core body temperature
Time frame: Week 5
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.
Cold detection threshold (CDT); °C
Time frame: Week 0
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.
Cold detection threshold (CDT); °C
Time frame: week 5
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.
Warm detection threshold (WDT); °C
Time frame: Week 0
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.
Warm detection threshold (WDT); °C
Time frame: week 5
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.
Thermal sensory limen (TSL) ; °C
Time frame: week 0
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.
Thermal sensory limen (TSL) ; °C
Time frame: week 5
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.
Cold pain threshold (CPT); °C
Time frame: week 0
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.
Cold pain threshold (CPT); °C
Time frame: week 5
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.
Heat pain threshold (HPT); °C
Time frame: week 0
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.
Heat pain threshold (HPT); °C
Time frame: week 5
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.
Mechanical detection threshold (MDT) ; mN
Time frame: week 0
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.
Mechanical detection threshold (MDT) ; mN
Time frame: week 5
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.
Mechanical pain threshold (MPT), count of sharp and blunt stimuli
Time frame: week 0
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.
Mechanical pain threshold (MPT), count of sharp and blunt stimuli
Time frame: week 5
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.
Mechanical pain sensitivity (MPS) ; NRS
Time frame: week 0
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.
Mechanical pain sensitivity (MPS) ; NRS
Time frame: week 5
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.
Summative pain amplification (WUR); NRS
Time frame: week 0
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.
Summative pain amplification (WUR); NRS
Time frame: week 5
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.
Vibration detection threshold (VDT) ; x/8
Time frame: week 0
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.
Vibration detection threshold (VDT) ; x/8
Time frame: week 5
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.
Pressure pain threshold (PPT), kgf/1cm2
Time frame: week 0
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.
Pressure pain threshold (PPT), kgf/1cm2
Time frame: week 5
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.
Dynamic mechanical allodynia (DMA), NRS
Time frame: week 0
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.
Dynamic mechanical allodynia (DMA), NRS
Time frame: week 5
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.
6-Minute Walk Test (6MWT)
Time frame: Week 0
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)
6-Minute Walk Test (6MWT)
Time frame: Week 5
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)
20 secondary outcomes
McGill Pain Questionnaire (MPQ)
Time frame: Week 0
McGill Pain Questionnaire (MPQ)
Time frame: Week 5
McGill Pain Questionnaire (MPQ)
Time frame: Week 12
McGill Pain Questionnaire (MPQ)
Time frame: Week 30
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Week 0
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Week 5
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Week 12
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Week 30
Multidimensional Fatigue Inventory (MFI-20)
Time frame: Week 0
Multidimensional Fatigue Inventory (MFI-20)
Time frame: Week 5
Multidimensional Fatigue Inventory (MFI-20)
Time frame: Week 12
Multidimensional Fatigue Inventory (MFI-20)
Time frame: Week 30
General Depression Scale (ADS-L)
Time frame: Week 0
General Depression Scale (ADS-L)
Time frame: Week 5
General Depression Scale (ADS-L)
Time frame: Week 12
General Depression Scale (ADS-L)
Time frame: Week 30
Avoidance-Endurance Fast-Screen (AEFS)
Time frame: week 0
Avoidance-Endurance Fast-Screen (AEFS)
Time frame: week 5
Avoidance-Endurance Fast-Screen (AEFS)
Time frame: week 12
Avoidance-Endurance Fast-Screen (AEFS)
Time frame: week 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kay-Uwe Hanusch, Dr.scient.med study director
Bern University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serial whole body hyperthermia in people with Hyperthermia and Chronic Primary Pain, run by Bern University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kay-Uwe Hanusch, Dr.scient.med (+41 31 848 5005, kay.hanusch@bfh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian core body temperature (time frame: Week 0). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.