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

ConditionsHyperthermiaChronic Primary PainWidespread PainMuscular DiseaseRheumatic DiseasesMusculoskeletal DiseasesNeuromuscular DiseaseFibromyalgiaCircadian RhythmBody Temperature ChangesSomatosensory FunctionQuantitative Sensory TestingHealthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBern University of Applied Sciences

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • serial whole body hyperthermia

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: serial whole body hyperthermiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Circadian core body temperature

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.

Time frame
Week 0
2

Circadian core body temperature

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.

Time frame
Week 5
3

Cold detection threshold (CDT); °C

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.

Time frame
Week 0
4

Cold detection threshold (CDT); °C

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.

Time frame
week 5

Secondary outcomes

1

McGill Pain Questionnaire (MPQ)

The instrument assesses subjective pain experience and evaluates both the quality and numerical intensity of pain (0 = no pain; 10 = worst pain imaginable)

Time frame
Week 0
2

McGill Pain Questionnaire (MPQ)

The instrument assesses subjective pain experience and evaluates both the quality and numerical intensity of pain (0 = no pain; 10 = worst pain imaginable)

Time frame
Week 5
3

McGill Pain Questionnaire (MPQ)

The instrument assesses subjective pain experience and evaluates both the quality and numerical intensity of pain (0 = no pain; 10 = worst pain imaginable)

Time frame
Week 12
4

McGill Pain Questionnaire (MPQ)

The instrument assesses subjective pain experience and evaluates both the quality and numerical intensity of pain (0 = no pain; 10 = worst pain imaginable)

Time frame
Week 30

Other outcomes

1

BDNF

Brain-Derived Neurotrophic Factor (BDNF) in blood to measure nociplasticity

Time frame
Week 0
2

BDNF

Brain-Derived Neurotrophic Factor (BDNF) in blood to measure nociplasticity

Time frame
Week 5
3

PRISE (Patient-Rated Inventory of Side Effects)

A tool used to assess the presence and severity of side effects (0=no severity, 3= greater severity) across nine organ/function domains, including gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual function, and other areas

Time frame
30min post treatment
4

PSST

The Premenstrual Symptoms Screening Tool (PSST) is used to assess the presence and severity of premenstrual symptoms and their impact on daily functioning. The tool translates categorical criteria into a rating scale. It consists of 19 items: 14 items regarding premenstrual symptoms and 5 items measuring functional impairment. Each item is rated on a 4-point Likert scale (0 = not at all, 1 = mild, 2 = moderate, 3 = severe). The total score is used to screen for Premenstrual Dysphoric Disorder (PMDD) and moderate-to-severe Premenstrual Syndrome (PMS), with higher ratings reflecting a higher symptom severity.

Time frame
During the pre-trial phase, specifically on day 2 after ovulation (luteal phase)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bern University of Applied Sciences

Lead sponsor

Dr. med. h.c Erwin Braun Stiftung

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: