Back to resultsHyperthermia in Fibromyalgia Syndrome (HYPAIN)
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hyperthermia Group
Sham-Group
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring hyperthermia, fibromyalgia syndrome, pain
Eligibility Criteria
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
Sites / Locations
- Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Hyperthermia Group
Sham-Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
Pain Diary
Pain diary measuring the daily pain level at baseline. It also includes medication intakes, accompanying treatments and space for additional comments.
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.
Additional Treatments/Change of Medication
Record of additional treatments/change of medication to control for effects.
Additional Treatments/Change of Medication
Record of additional treatments/change of medication to control for effects.
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).
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).
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).
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).
age
age in years
sex
identification of gender
height
in meters
weight
in kg
marital status
identification of marital status
education
identification of the educational level
job
identification of the current job (4 questions about job/application for pension)
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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).
Adverse events (AE)
Description of adverse events during the interventions by therapists.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05135936
Brief Title
Hyperthermia in Fibromyalgia Syndrome
Acronym
HYPAIN
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jost Langhorst
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
hyperthermia, fibromyalgia syndrome, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment, Sham- and treatmentgroup
Masking
Participant
Masking Description
Single
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperthermia Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham-Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hyperthermia Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham-Group
Intervention Description
The number of treatments is equal to the number of treatments in the intervention group.
Primary Outcome Measure Information:
Title
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
Description
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
Title
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
Description
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
Secondary Outcome Measure Information:
Title
Multidimensionl Fatigue Inventory (MFI-20)
Description
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
Title
Multidimensionl Fatigue Inventory (MFI-20)
Description
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
Title
Multidimensionl Fatigue Inventory (MFI-20)
Description
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
Title
Multidimensionl Fatigue Inventory (MFI-20)
Description
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
Title
Pittsburgh Sleep quality index (PSQI)
Description
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
Title
Pittsburgh Sleep quality index (PSQI)
Description
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
Title
Pittsburgh Sleep quality index (PSQI)
Description
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
Title
Pittsburgh Sleep quality index (PSQI)
Description
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
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
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
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
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
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
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
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
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
Title
Patient Global Impression of Change
Description
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
Title
Patient Global Impression of Change
Description
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
Title
Patient Global Impression of Change
Description
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
Title
Pain Diary
Description
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
Title
Pain Diary
Description
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
Title
Additional Treatments/Change of Medication
Description
Record of additional treatments/change of medication to control for effects.
Time Frame
Week 12
Title
Additional Treatments/Change of Medication
Description
Record of additional treatments/change of medication to control for effects.
Time Frame
Week 30
Title
Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
Description
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
Title
Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
Description
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
Title
Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
Description
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
Title
Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
Description
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
Title
age
Description
age in years
Time Frame
Week 0
Title
sex
Description
identification of gender
Time Frame
Week 0
Title
height
Description
in meters
Time Frame
Week 0
Title
weight
Description
in kg
Time Frame
Week 0
Title
marital status
Description
identification of marital status
Time Frame
Week 0
Title
education
Description
identification of the educational level
Time Frame
Week 0
Title
job
Description
identification of the current job (4 questions about job/application for pension)
Time Frame
Week 0
Title
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Description
A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.
Time Frame
Week 0
Title
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Description
A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.
Time Frame
Week 4
Title
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Description
A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.
Time Frame
Week 12
Title
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Description
A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.
Time Frame
Week 30
Title
SF-36 health survey
Description
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
Title
SF-36 health survey
Description
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
Title
SF-36 health survey
Description
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
Title
SF-36 health survey
Description
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
Title
Shortform of PHQ-D (Patient Health Questionnaire)
Description
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
Title
Shortform of PHQ-D (Patient Health Questionnaire)
Description
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
Title
Shortform of PHQ-D (Patient Health Questionnaire)
Description
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
Title
Shortform of PHQ-D (Patient Health Questionnaire)
Description
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
Title
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
Description
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
Title
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
Description
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
Title
Patient Interview
Description
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
Title
Adverse events (AE)
Description
Description of adverse events during the interventions by therapists.
Time Frame
Week 1-3
Other Pre-specified Outcome Measures:
Title
Blood count
Description
(to measure baseline status)
Time Frame
Week 0
Title
Blood count
Description
(to measure acute effects)
Time Frame
Week 3 - after last intervention
Title
Blood count
Description
(to measure acute effects)
Time Frame
Week 4
Title
C-reactive Protein (CRP)
Description
Level of c-reactive protein (CRP) in blood to measure inflammation.
Time Frame
Week 0
Title
C-reactive Protein (CRP)
Description
Level of c-reactive protein (CRP) in blood to measure inflammation (to measure acute effects).
Time Frame
Week 3 - after last intervention
Title
C-reactive Protein (CRP)
Description
Level of c-reactive protein (CRP) in blood to measure inflammation.
Time Frame
Week 4
Title
Blood cell sedimenation rate (BSG)
Description
Serum parameter.
Time Frame
Week 0
Title
Blood cell sedimenation rate (BSG)
Description
Serum parameter (to measure acute effects).
Time Frame
Week 3 - after last intervention
Title
Blood cell sedimenation rate (BSG)
Description
Serum parameter.
Time Frame
Week 4
Title
Coagulation
Description
Coagulation measured in blood.
Time Frame
Week 0
Title
Coagulation
Description
Coagulation measured in blood.
Time Frame
Week 3 - after last intervention
Title
Coagulation
Description
Coagulation measured in blood.
Time Frame
Week 4
Title
Tumor Necrosis Factor (TNF-α)
Description
Serum parameter.
Time Frame
Week 0
Title
Tumor Necrosis Factor (TNF-α)
Description
Serum parameter.
Time Frame
Week 3 - after last intervention
Title
Tumor Necrosis Factor (TNF-α)
Description
Serum parameter.
Time Frame
Week 4
Title
Interleukin-1 (IL-1)
Description
Serum parameter (Zytokines).
Time Frame
Week 0
Title
Interleukin-1 (IL-1)
Description
Serum parameter (Zytokines).
Time Frame
Week 3 - after last intervention
Title
Interleukin-1 (IL-1)
Description
Serum parameter (Zytokines).
Time Frame
Week 4
Title
Interleukin-6 (IL-6)
Description
Serum parameter (Zytokines).
Time Frame
Week 0
Title
Interleukin-6 (IL-6)
Description
Serum parameter (Zytokines).
Time Frame
Week 3 - after last intervention
Title
Interleukin-6 (IL-6)
Description
Serum parameter (Zytokines).
Time Frame
Week 4
Title
Interleukin-8 (IL-8)
Description
Serum parameter (Zytokines).
Time Frame
Week 0
Title
Interleukin-8 (IL-8)
Description
Serum parameter (Zytokines).
Time Frame
Week 3 - after last intervention
Title
Interleukin-8 (IL-8)
Description
Serum parameter (Zytokines).
Time Frame
Week 4
Title
Interleukin-10 (IL-10)
Description
Serum parameter (Zytokines).
Time Frame
Week 0
Title
Interleukin-10 (IL-10)
Description
Serum parameter (Zytokines).
Time Frame
Week 3 - after last intervention
Title
Interleukin-10 (IL-10)
Description
Serum parameter (Zytokines).
Time Frame
Week 4
Title
creatinine
Description
Serum parameter.
Time Frame
Week 4
Title
GOT, GPT, GGT
Description
Serum Parameters - Liver enzymes.
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jost Langhorst, Prof.
Organizational Affiliation
Sozialstiftung Bamberg
Official's Role
Study Director
Facility Information:
Facility Name
Sozialstiftung Bamberg, Klinik für Intergrative Medizin
City
Bamberg
State/Province
Bayern
ZIP/Postal Code
96049
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hyperthermia in Fibromyalgia Syndrome
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