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

NCT ID: NCT07101978

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-01-01

Brief Summary

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.

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.

Conditions

Hyperthermia; Chronic Primary Pain; Widespread Pain; Muscular Disease; Rheumatic Diseases; Musculoskeletal Diseases; Neuromuscular Disease; Fibromyalgia; Circadian Rhythm; Body Temperature Changes; Somatosensory Function; Quantitative Sensory Testing; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

serial whole body hyperthermia

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.

Group Type: EXPERIMENTAL

serial whole body hyperthermia

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

passive whole body hyperthermia; water filtered whole body hyperthermia; moderate whole body infrared-A hyperthermia

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. med. h.c Erwin Braun Stiftung

UNKNOWN

Sponsor Role: collaborator

Bern University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Kay-Uwe Hanusch

Principal Investigator,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kay-Uwe Hanusch, Dr.scient.med

Role: STUDY_DIRECTOR

Bern University of Applied Sciences

Locations

Bern University of Applied Science

Bern, Canton of Bern, Switzerland

Countries

Switzerland

Central Contacts

Kay-Uwe Hanusch, Dr.scient.med

Role: CONTACT

kay.hanusch@bfh.ch

+41 31 848 5005

Facility Contacts

Kay-Uwe Hanusch, Dr.scient.med

Role: primary

kay.hanusch@bfh.ch

+41 31 848 5005

Other Identifiers

F.016677-42-PHYW-1

Identifier Type: -

Identifier Source: org_study_id