Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2020-11-12
2021-12-13
Brief Summary
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The duration of the study is about 3 weeks with two treatment units per week and a passive period (follow-up measurement) of 24 weeks after the outpatient setting.
Detailed Description
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Before the start and after the completion of the studies, within the clinical stay, blood parameters were collected. In order to determine the secondary effectiveness of different questionnaire values are also collected. These are also documented after week 12 and after week 24, by means of telephone enquiries.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hyperthermia Group
For the study, the method of passive whole-body hyperthermia is used. The IRATHERM®1000 system (Von Ardenne Institute for Applied Medical Research/Dresden) 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 60 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 1.5 to 2 hours, but this depends on the individual constitution and daily condition of the patient and can be subject to fluctuations.
Hyperthermia Group
The first hyperthermia treatment of the series is carried out for the second aptitude test, directly following the randomisation in the intervention group at the Hospital for Naturopathy and Integrative Medicine in Bamberg. The hyperthermia treatment is then 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 hyperthermia treatment. During the treatment, continuous supervision by trained personnel is guaranteed, and a doctor is on call.
Sham-Group
Within the patient information, privacy policy, etc., there is talk of "gentle hyperthermia" and classic, "mild hyperthermia". This serves to introduce the sham intervention as a control group compared to the patient. Lighting conditions, procedures, instructions and explanations are indistinguishable. Within the application, patients of the sham group will receive a hyperthermia application almost without overheating. In order to achieve this, the patients will be positioned on the IRATHERM®1000 in accordance with the Von Ardenne Institute's regulations. Due to the insulating blanket and the natural device and body heat, the patients of the sham group experience a gentle warmth, which is not the same as regular whole-body hyperthermia and an increase in the body core temperature of about 1.5 °C. In the sham setting, the core body temperature increases by about 0.3 to 0.4 °C within a 55-minute session.
Sham-Group
The number of treatments is equal to the number of treatments in the intervention group.
Interventions
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Hyperthermia Group
The first hyperthermia treatment of the series is carried out for the second aptitude test, directly following the randomisation in the intervention group at the Hospital for Naturopathy and Integrative Medicine in Bamberg. The hyperthermia treatment is then 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 hyperthermia treatment. During the treatment, continuous supervision by trained personnel is guaranteed, and a doctor is on call.
Sham-Group
The number of treatments is equal to the number of treatments in the intervention group.
Eligibility Criteria
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Inclusion Criteria
* Pain VAS \>= 4,0
* Signed declaration of consent
Exclusion Criteria
* Contraindications for hyperthermia (severe cardiovascular diseases, tumour diseases, acute infections, pregnant and breastfeeding women)
* Acute and / or feverish microbial infections
* Patients with severe somatic, rheumatic concomitant endocrine or neurological diseases, in particular neurological diseases associated with cognitive disorders, severe liver or kidney and cardiac diseases
* Patients 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
* Patients with pain due to a serious psychiatric illness (bipolar disorder, psychosis, personality disorder, severe depression, substance abuse) and serious systemic or neurological disorders
18 Years
70 Years
ALL
No
Sponsors
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Jost Langhorst
OTHER
Responsible Party
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Jost Langhorst
Prof.
Principal Investigators
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Jost Langhorst, Prof.
Role: STUDY_DIRECTOR
Sozialstiftung Bamberg
Locations
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Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Bamberg, Bavaria, Germany
Countries
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Other Identifiers
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20079
Identifier Type: -
Identifier Source: org_study_id