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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Circadian core body temperature [Срок оценки: Week 0]
• Circadian core body temperature [Срок оценки: Week 5]
• Cold detection threshold (CDT); °C [Срок оценки: Week 0]
• Cold detection threshold (CDT); °C [Срок оценки: week 5]
• Warm detection threshold (WDT); °C [Срок оценки: Week 0]
• Warm detection threshold (WDT); °C [Срок оценки: week 5]
• Thermal sensory limen (TSL) ; °C [Срок оценки: week 0]
• Thermal sensory limen (TSL) ; °C [Срок оценки: week 5]
• Cold pain threshold (CPT); °C [Срок оценки: week 0]
• Cold pain threshold (CPT); °C [Срок оценки: week 5]

Вторичные конечные точки (12)

• McGill Pain Questionnaire (MPQ) [Срок оценки: Week 0]
• McGill Pain Questionnaire (MPQ) [Срок оценки: Week 5]
• McGill Pain Questionnaire (MPQ) [Срок оценки: Week 12]
• McGill Pain Questionnaire (MPQ) [Срок оценки: Week 30]
• Fear Avoidance Beliefs Questionnaire (FABQ) [Срок оценки: Week 0]
• Fear Avoidance Beliefs Questionnaire (FABQ) [Срок оценки: Week 5]
• Fear Avoidance Beliefs Questionnaire (FABQ) [Срок оценки: Week 12]
• Fear Avoidance Beliefs Questionnaire (FABQ) [Срок оценки: Week 30]
• Multidimensional Fatigue Inventory (MFI-20) [Срок оценки: Week 0]
• Multidimensional Fatigue Inventory (MFI-20) [Срок оценки: Week 5]
• Multidimensional Fatigue Inventory (MFI-20) [Срок оценки: Week 12]
• Multidimensional Fatigue Inventory (MFI-20) [Срок оценки: Week 30]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Bern University of Applied Science — Bern

Идентификаторы

NCT: NCT07101978 · F.016677-42-PHYW-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗