Body Temperature Changes, Chronic Primary Pain, Circadian Rhythm, Fibromyalgia, Healthy, Hyperthermia, Muscular Disease, Musculoskeletal Diseases, Neuromuscular Disease, Quantitative Sensory Testing, Rheumatic Diseases, Somatosensory Function, Widespread Pain
Conditions
Keywords
hyperthermia, widespread pain, chronic primary pain, circadian body temperature, quantitative sensory testing, healthy
Brief 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.
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
BEHAVIORALserial 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.
Sponsors
Bern University of Applied Sciences
Dr. med. h.c Erwin Braun Stiftung
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Quasi-experimental, matched two group pre-post study design with a healthy and a patients group with the the same intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circadian core body temperature | Week 0 | 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. |
| Cold detection threshold (CDT); °C | Week 0 | 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. |
| Warm detection threshold (WDT); °C | Week 0 | 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. |
| Thermal sensory limen (TSL) ; °C | week 0 | 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. |
| Cold pain threshold (CPT); °C | week 0 | 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. |
| Heat pain threshold (HPT); °C | week 0 | 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. |
| Mechanical detection threshold (MDT) ; mN | week 0 | 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. |
| Mechanical pain threshold (MPT), count of sharp and blunt stimuli | week 0 | 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. |
| Mechanical pain sensitivity (MPS) ; NRS | week 0 | 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. |
| Summative pain amplification (WUR); NRS | week 0 | 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. |
| Vibration detection threshold (VDT) ; x/8 | week 0 | 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. |
| Pressure pain threshold (PPT), kgf/1cm2 | week 0 | 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. |
| Dynamic mechanical allodynia (DMA), NRS | week 0 | 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. |
| 6-Minute Walk Test (6MWT) | Week 0 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| McGill Pain Questionnaire (MPQ) | Week 0 | The instrument assesses subjective pain experience and evaluates both the quality and numerical intensity of pain (0 = no pain; 10 = worst pain imaginable) |
| Fear Avoidance Beliefs Questionnaire (FABQ) | Week 0 | Is a psychological questionnaire designed to assess a person's beliefs about how physical activity and work may influence their pain. It focuses on fear-avoidance behaviours, particularly in individuals with musculoskeletal pain (e.g., low back pain). The questionnaire consists of 16 items divided into two subscales: physical activity (FABQ-PA) and work (FABQ-W). Items are rated on a 7-point Likert scale (from "completely disagree" to "completely agree"). |
| Multidimensional Fatigue Inventory (MFI-20) | Week 0 | An inventory including 20 questions about fatigue-symptoms (each from 1 ("Yes, that is true") to 5 ("No, that is not true")) covering 5 dimensions (general fatigue, physical fatigue, reduced motivation, reduced activity, mental fatigue) |
| General Depression Scale (ADS-L) | Week 0 | is a german self-report questionnaire designed to assess depressive symptoms in the general population adapted from the CES-D. (20 items, 4-point Likert scale (0 = rarely or none of the time, 3 = most or all of the time) |
| Avoidance-Endurance Fast-Screen (AEFS) | week 0 | Description: Is a short screening questionnaire designed to identify maladaptive pain coping patterns, specifically avoidance and endurance behaviours in individuals with musculoskeletal pain. It differentiates between fear-avoidance responses and endurance-related coping styles (e.g., persistence despite pain). The AEFS includes a 7-point scale (0=never to 6=always) for Pain Persistence (PPS) from the Avoidance-Endurance Questionnaire (AEQ), as well as two dichotomous (0=yes, 1=no) mood items from the Beck-Depressions-Inventar. The PPS scale is administered using two response scales for coping with mild and severe pain. |
Countries
Switzerland
Contacts
CONTACTKay-Uwe Hanusch, Dr.scient.med
STUDY_DIRECTORKay-Uwe Hanusch, Dr.scient.med
Bern University of Applied Sciences
Outcome results
None listed