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

Sponsor
Bern University of Applied Sciences
Study ID
NCT07101978
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • serial whole body hyperthermia — 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.

Study Details

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.

Key Dates

First listed
Aug 3, 2025
Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Aug 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Circadian core body temperature [ Time Frame: Week 0 ]

Central Contacts

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