Hyperthermia in Fibromyalgia Syndrome

Study Overview
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Brief Summary
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This study will examine the effectiveness of water-filtered whole-body hyperthermia during an outpatient setting in patients with fibromyalgia. 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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A total of about 40 participants over 18 years of age are sought, who will be divided into two groups of equal size after inclusion in the study. All participants will receive the same amount of water-filtered whole-body hyperthermia within the outpatient setting. One group receives the gentle form of GKHT, the other group receives the classic, mild GHKT. All abnormalities are documented by the responsible therapists, doctors and nurses. Changes in the area of pain and functional limitations as well as the intake of required medication are also recorded. 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.

Official Title
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A Randomised Sham-controlled Study on the Effectiveness of Mild Water-filtered Infrared-A Whole-body Hyperthermia in Improving Symptoms and Quality of Life in Patients With Fibromyalgia Syndrome

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Hyperthermia Group
* Behavioral: Sham-Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis of fibromyalgia (FSQ) Pain VAS >= 4,0 Signed declaration of consent 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment, Sham- and treatmentgroup
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperthermia Group<br>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. | Behavioral: Hyperthermia Group<br>* 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.<br>|
| Sham Comparator: Sham-Group<br>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. | Behavioral: Sham-Group<br>* The number of treatments is equal to the number of treatments in the intervention group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS) | An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable); primary outcome), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. | Week 0 | 
| Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS) | An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable); primary outcome), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensionl Fatigue Inventory (MFI-20) | 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). | Week 0 | 
| Multidimensionl Fatigue Inventory (MFI-20) | 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). | Week 4 | 
| Multidimensionl Fatigue Inventory (MFI-20) | 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). | Week 12 | 
| Multidimensionl Fatigue Inventory (MFI-20) | 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). | Week 30 | 
| Pittsburgh Sleep quality index (PSQI) | An inventory including 10 questions (plus subquestions) about the quality of sleep. Most of the questions range from (Not during the past month to thee or more times a week). The questions can be calculated in seven subscales. | Week 0 | 
| Pittsburgh Sleep quality index (PSQI) | An inventory including 10 questions (plus subquestions) about the quality of sleep. Most of the questions range from (Not during the past month to thee or more times a week). The questions can be calculated in seven subscales. | Week 4 | 
| Pittsburgh Sleep quality index (PSQI) | An inventory including 10 questions (plus subquestions) about the quality of sleep. Most of the questions range from (Not during the past month to thee or more times a week). The questions can be calculated in seven subscales. | Week 12 | 
| Pittsburgh Sleep quality index (PSQI) | An inventory including 10 questions (plus subquestions) about the quality of sleep. Most of the questions range from (Not during the past month to thee or more times a week). The questions can be calculated in seven subscales. | Week 30 | 
| Fibromyalgia Impact Questionnaire (FIQ) | An inventory measuring the disease-specific quality of life including 10 questions. The first question covers physical functioning ranging from 0 (always) to 3 (never). The second question is about wellbeing and the third examines the ability to work. Question 4-10 examine restrictions with visual analog scales (e.g. 0mm = not tired; 100mm = very tired) covering various symptoms like fatigue, anxiety or depression. | Week 0 | 
| Fibromyalgia Impact Questionnaire (FIQ) | An inventory measuring the disease-specific quality of life including 10 questions. The first question covers physical functioning ranging from 0 (always) to 3 (never). The second question is about wellbeing and the third examines the ability to work. Question 4-10 examine restrictions with visual analog scales (e.g. 0mm = not tired; 100mm = very tired) covering various symptoms like fatigue, anxiety or depression. | Week 4 | 
| Fibromyalgia Impact Questionnaire (FIQ) | An inventory measuring the disease-specific quality of life including 10 questions. The first question covers physical functioning ranging from 0 (always) to 3 (never). The second question is about wellbeing and the third examines the ability to work. Question 4-10 examine restrictions with visual analog scales (e.g. 0mm = not tired; 100mm = very tired) covering various symptoms like fatigue, anxiety or depression. | Week 12 | 
| Fibromyalgia Impact Questionnaire (FIQ) | An inventory measuring the disease-specific quality of life including 10 questions. The first question covers physical functioning ranging from 0 (always) to 3 (never). The second question is about wellbeing and the third examines the ability to work. Question 4-10 examine restrictions with visual analog scales (e.g. 0mm = not tired; 100mm = very tired) covering various symptoms like fatigue, anxiety or depression. | Week 30 | 
| Patient Global Impression of Change | One question about the patients global impression of change due to the therapy ranging from 1 (very much improved) to 7 (very much worse). | Week 4 | 
| Patient Global Impression of Change | One question about the patients global impression of change due to the therapy ranging from 1 (very much improved) to 7 (very much worse). | Week 12 | 
| Patient Global Impression of Change | One question about the patients global impression of change due to the therapy ranging from 1 (very much improved) to 7 (very much worse). | Week 30 | 
| Pain Diary | Pain diary measuring the daily pain level at baseline. It also includes medication intakes, accompanying treatments and space for additional comments. | Week -2-0 | 
| Pain Diary | Pain diary measuring the daily pain level during the period of intervention. It also includes medication intakes, accompanying treatments and space for additional comments. | Week 1-3 | 
| Additional Treatments/Change of Medication | Record of additional treatments/change of medication to control for effects. | Week 12 | 
| Additional Treatments/Change of Medication | Record of additional treatments/change of medication to control for effects. | Week 30 | 
| Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D) | The pain inventory includes three questions. The first one examines the quality of the pain with 15 items e.g. throbbing, shooting raning from 0 (None) to 3 (severe). The second question examines the current level of pain with a visal analog scale (0mm= No Pain, 100mm= worst possible pain). The third one examines the intensitiy of the whole pain experience (0=no Pain, 5 = excruciating). | Week 0 | 
| Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D) | The pain inventory includes three questions. The first one examines the quality of the pain with 15 items e.g. throbbing, shooting raning from 0 (None) to 3 (severe). The second question examines the current level of pain with a visal analog scale (0mm= No Pain, 100mm= worst possible pain). The third one examines the intensitiy of the whole pain experinece (0=no Pain, 5 = excruciating). | Week 4 | 
| Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D) | The pain inventory includes three questions. The first one examines the quality of the pain with 15 items e.g. throbbing, shooting raning from 0 (None) to 3 (severe). The second question examines the current level of pain with a visal analog scale (0mm= No Pain, 100mm= worst possible pain). The third one examines the intensitiy of the whole pain experience (0=no Pain, 5 = excruciating). | Week 12 | 
| Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D) | The pain inventory includes three questions. The first one examines the quality of the pain with 15 items e.g. throbbing, shooting raning from 0 (None) to 3 (severe). The second question examines the current level of pain with a visal analog scale (0mm= No Pain, 100mm= worst possible pain). The third one examines the intensitiy of the whole pain experience (0=no Pain, 5 = excruciating). | Week 30 | 
| age | age in years | Week 0 | 
| sex | identification of gender | Week 0 | 
| height | in meters | Week 0 | 
| weight | in kg | Week 0 | 
| marital status | identification of marital status | Week 0 | 
| education | identification of the educational level | Week 0 | 
| job | identification of the current job (4 questions about job/application for pension) | Week 0 | 
| G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects) | A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects. | Week 0 | 
| G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects) | A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects. | Week 4 | 
| G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects) | A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects. | Week 12 | 
| G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects) | A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects. | Week 30 | 
| SF-36 health survey | An inventory including 36 item measuring the current health status and generic quality of life of the patients. It includes eight subscales, that can be summarized in one physical and one psychological summary scale. | Week 0 | 
| SF-36 health survey | An inventory including 36 item measuring the current health status and generic quality of life of the patients. It includes eight subscales, that can be summarized in one physical and one psychological summary scale. | Week 4 | 
| SF-36 health survey | An inventory including 36 item measuring the current health status and generic quality of life of the patients. It includes eight subscales, that can be summarized in one physical and one psychological summary scale. | Week 12 | 
| SF-36 health survey | An inventory including 36 item measuring the current health status and generic quality of life of the patients. It includes eight subscales, that can be summarized in one physical and one psychological summary scale. | Week 30 | 
| Shortform of PHQ-D (Patient Health Questionnaire) | An inventory measurung the psychological health status including among others 9 items about depression (PHQ-9), 15 items about somatization (PHQ-15) and 7 items about general anxietey (GAD-7). | Week 0 | 
| Shortform of PHQ-D (Patient Health Questionnaire) | An inventory measurung the psychological health status including among others 9 items about depression (PHQ-9), 15 items about somatization (PHQ-15) and 7 items about general anxietey (GAD-7). | Week 4 | 
| Shortform of PHQ-D (Patient Health Questionnaire) | An inventory measurung the psychological health status including among others 9 items about depression (PHQ-9), 15 items about somatization (PHQ-15) and 7 items about general anxietey (GAD-7). | Week 12 | 
| Shortform of PHQ-D (Patient Health Questionnaire) | An inventory measurung the psychological health status including among others 9 items about depression (PHQ-9), 15 items about somatization (PHQ-15) and 7 items about general anxietey (GAD-7). | Week 30 | 
| Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS) | An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. | Week 12 | 
| Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS) | An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. | Week 30 | 
| Patient Interview | Qualitative telephone interviews with 10 patients of the mild whole body hyperthermia group (Experimental group) to get detailed experiences of the patients (30-45 min). | Week 12 | 
| Adverse events (AE) | Description of adverse events during the interventions by therapists. | Week 1-3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperthermia, fibromyalgia syndrome, pain