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NCT07101978
Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain
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
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Bern University of Applied Sciences
Location: Bern University of Applied Science Bern Canton of Bern
Summary
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.
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
Source: ClinicalTrials.gov (NCT07101978). StuddyBuddy aggregates publicly available trial information.