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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Single
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Hyperthermia Group (Behavioral)
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.
Intervention: Sham-Group (Behavioral)
Outcomes
Primary Outcomes
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
Time Frame: Week 4
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)
Time Frame: Week 0
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 Outcomes
- weight(Week 0)
- Multidimensionl Fatigue Inventory (MFI-20)(Week 30)
- Fibromyalgia Impact Questionnaire (FIQ)(Week 30)
- Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)(Week 30)
- SF-36 health survey(Week 30)
- Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)(Week 30)
- Pittsburgh Sleep quality index (PSQI)(Week 30)
- Additional Treatments/Change of Medication(Week 30)
- G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)(Week 30)
- Patient Global Impression of Change(Week 30)
- Pain Diary(Week 1-3)
- Patient Interview(Week 12)
- sex(Week 0)
- height(Week 0)
- marital status(Week 0)
- education(Week 0)
- job(Week 0)
- Adverse events (AE)(Week 1-3)
- age(Week 0)
- Shortform of PHQ-D (Patient Health Questionnaire)(Week 30)
- Multidimensionl Fatigue Inventory (MFI-20)(Week 0)
- Multidimensionl Fatigue Inventory (MFI-20)(Week 4)
- Multidimensionl Fatigue Inventory (MFI-20)(Week 12)
- Pittsburgh Sleep quality index (PSQI)(Week 0)
- Pittsburgh Sleep quality index (PSQI)(Week 4)
- Pittsburgh Sleep quality index (PSQI)(Week 12)
- Fibromyalgia Impact Questionnaire (FIQ)(Week 0)
- Fibromyalgia Impact Questionnaire (FIQ)(Week 4)
- Fibromyalgia Impact Questionnaire (FIQ)(Week 12)
- Patient Global Impression of Change(Week 4)
- Patient Global Impression of Change(Week 12)
- Pain Diary(Week -2-0)
- Additional Treatments/Change of Medication(Week 12)
- Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)(Week 0)
- Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)(Week 4)
- Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)(Week 12)
- G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)(Week 0)
- G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)(Week 4)
- G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)(Week 12)
- SF-36 health survey(Week 0)
- SF-36 health survey(Week 4)
- SF-36 health survey(Week 12)
- Shortform of PHQ-D (Patient Health Questionnaire)(Week 0)
- Shortform of PHQ-D (Patient Health Questionnaire)(Week 4)
- Shortform of PHQ-D (Patient Health Questionnaire)(Week 12)
- Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)(Week 12)
Investigators
Jost Langhorst
Prof.
Universität Duisburg-Essen