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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
41
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.
The number of treatments is equal to the number of treatments in the intervention group.
Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Bamberg, Bavaria, Germany
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Week 12
Multidimensionl Fatigue Inventory (MFI-20)
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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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Week 1-3
Additional Treatments/Change of Medication
Record of additional treatments/change of medication to control for effects.
Time frame: Week 12
Additional Treatments/Change of Medication
Record of additional treatments/change of medication to control for effects.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Week 30
age
age in years
Time frame: Week 0
sex
identification of gender
Time frame: Week 0
height
in meters
Time frame: Week 0
weight
in kg
Time frame: Week 0
marital status
identification of marital status
Time frame: Week 0
education
identification of the educational level
Time frame: Week 0
job
identification of the current job (4 questions about job/application for pension)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Week 12
Adverse events (AE)
Description of adverse events during the interventions by therapists.
Time frame: Week 1-3