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Not yet recruiting NCT07101978

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

No phase Interventional Hyperthermia Chronic Primary Pain Widespread Pain Muscular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: serial whole body hyperthermia.
Who it may be relevant to
Registry conditions: Hyperthermia, Chronic Primary Pain, Widespread Pain, Muscular Disease. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Hyperthermia in Healthy and Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System, Movement Evoked Pain (HYPPRI-1)

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Circadian core body temperature [Time frame: Week 0]
  • Circadian core body temperature [Time frame: Week 5]
  • Cold detection threshold (CDT); °C [Time frame: Week 0]
  • Cold detection threshold (CDT); °C [Time frame: week 5]
  • Warm detection threshold (WDT); °C [Time frame: Week 0]
  • Warm detection threshold (WDT); °C [Time frame: week 5]
  • Thermal sensory limen (TSL) ; °C [Time frame: week 0]
  • Thermal sensory limen (TSL) ; °C [Time frame: week 5]
  • Cold pain threshold (CPT); °C [Time frame: week 0]
  • Cold pain threshold (CPT); °C [Time frame: week 5]
Secondary outcome measures (12)
  • McGill Pain Questionnaire (MPQ) [Time frame: Week 0]
  • McGill Pain Questionnaire (MPQ) [Time frame: Week 5]
  • McGill Pain Questionnaire (MPQ) [Time frame: Week 12]
  • McGill Pain Questionnaire (MPQ) [Time frame: Week 30]
  • Fear Avoidance Beliefs Questionnaire (FABQ) [Time frame: Week 0]
  • Fear Avoidance Beliefs Questionnaire (FABQ) [Time frame: Week 5]
  • Fear Avoidance Beliefs Questionnaire (FABQ) [Time frame: Week 12]
  • Fear Avoidance Beliefs Questionnaire (FABQ) [Time frame: Week 30]
  • Multidimensional Fatigue Inventory (MFI-20) [Time frame: Week 0]
  • Multidimensional Fatigue Inventory (MFI-20) [Time frame: Week 5]
  • Multidimensional Fatigue Inventory (MFI-20) [Time frame: Week 12]
  • Multidimensional Fatigue Inventory (MFI-20) [Time frame: Week 30]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Bern University of Applied Science — Bern

Identifiers

NCT: NCT07101978 · F.016677-42-PHYW-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗