Not yet recruitingNo phase

Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain

Key facts

Who runs it: Bern University of Applied Sciences
Where: Switzerland1 site in 1 countryChoose a country to see its sites
Trial code: NCT07101978
Status: Not yet recruiting
People taking part: 60 people, planned
Starts: 1 Dec 2026
Expected to end: 31 Mar 2029
Type of study: Interventional
Treatments tested: serial whole body hyperthermia
Record updated: 30 September 2026

Who can take part

Age: 18 years to 70 years
Sex: Women and men
Healthy volunteers: Can take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

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; 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 take part

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
Intake of medication within 6 weeks that inhibits the reuptake of the neurotransmitter serotonin or binds to receptors of this neurotransmitter group
Contraindications for hyperthermia (severe cardiovascular diseases, tumour diseases, acute infections, pregnant and breastfeeding women)
Acute and / or feverish microbial infections
participants with pain due to a serious psychiatric illness (bipolar disorder, psychosis, personality disorder, severe depression, substance abuse) and serious systemic or neurological disorders
Participation in other clinical studies
pregnancy or breastfeeding (for women)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

serial whole body hyperthermiaTreatment being tested
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.