Hyperthermia in Healthy and Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System, Movement Evoked Pain (HYPPRI-1)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Circadian core body temperature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
serial whole body hyperthermia
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.
干预措施: serial whole body hyperthermia (Behavioral)
结局指标
主要结局
Circadian core body temperature
时间窗: Week 5
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
时间窗: week 5
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
时间窗: week 5
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.
6-Minute Walk Test (6MWT)
时间窗: Week 5
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)
Thermal sensory limen (TSL) ; °C
时间窗: week 5
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
时间窗: week 5
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
时间窗: week 5
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
时间窗: week 5
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
时间窗: week 5
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
时间窗: week 5
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.
Pressure pain threshold (PPT), kgf/1cm2
时间窗: week 5
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.
Summative pain amplification (WUR); NRS
时间窗: week 5
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
时间窗: week 5
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.
Dynamic mechanical allodynia (DMA), NRS
时间窗: week 5
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.
次要结局
- McGill Pain Questionnaire (MPQ)(Week 30)
- TAMPA-Scale (Kinesiophobia)(Week 30)
- Multidimensional Fatigue Inventory (MFI-20)(Week 30)
- General Depression Scale (ADS-L)(Week 30)
研究者
Kay-Uwe Hanusch
Principal Investigator,
Bern University of Applied Sciences