NCT07101978

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

Influence of Serial Whole-body Hyperthermia on Circadian Core Body Temperature, the Somatosensory System and Movement Evoked Pain: Differences Between Healthy Subjects and Patients With Chronic Primary Pain

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Bern University of Applied Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-06-30
• Completion: 2028-01-01
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: Switzerland