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

NCT07101978 | Not Yet Recruiting DMC

• 1 other identifier: F.016677-42-PHYW-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Keywords

hyperthermia; widespread pain; chronic primary pain; circadian body temperature; quantitative sensory testing; healthy

Outcome Measures

Primary Outcomes (28)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  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)

  Week 5

Secondary Outcomes (16)

• McGill Pain Questionnaire (MPQ)

  Week 0

• McGill Pain Questionnaire (MPQ)

  Week 5

• McGill Pain Questionnaire (MPQ)

  Week 12

• McGill Pain Questionnaire (MPQ)

  Week 30

• TAMPA-Scale (Kinesiophobia)

  Week 0

Other Outcomes (3)

• BDNF

  Week 0

• BDNF

  Week 5

• PRISE (Patient-Rated Inventory of Side Effects)

  30min post treatment

Study Arms (1)

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.

Behavioral: serial whole body hyperthermia

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.

Also known as: passive whole body hyperthermia, water filtered whole body hyperthermia, moderate whole body infrared-A hyperthermia

serial whole body hyperthermia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bern University of Applied Sciences: lead
• Dr. med. h.c Erwin Braun Stiftung: collaborator

Study Sites (1)

Bern University of Applied Science

Bern, Canton of Bern, 3012, Switzerland

Location

MeSH Terms

Conditions

Hyperthermia; Chronic Pain; Muscular Diseases; Rheumatic Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Fibromyalgia; Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Pain; Neurologic Manifestations; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kay-Uwe Hanusch, Dr.scient.med

  Bern University of Applied Sciences

  STUDY DIRECTOR

Central Study Contacts

Kay-Uwe Hanusch, Dr.scient.med

CONTACT

+41 31 848 5005; kay.hanusch@bfh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,

Model Details: Quasi-experimental pre-post study design with a healthy and a patients group with the the same intervention

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)