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

Bern University of Applied Sciences

Status: Not yet enrolling

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

Treatments: Behavioral: serial whole body hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT07101978

F.016677-42-PHYW-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

serial whole body hyperthermia

Experimental group

Description:

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.

Treatment:

Behavioral: serial whole body hyperthermia