Fibromyalgia
Conditions
Keywords
hyperthermia, fibromyalgia syndrome, pain
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.
Interventions
BEHAVIORALHyperthermia 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.
BEHAVIORALSham-Group
The number of treatments is equal to the number of treatments in the intervention group.
Sponsors
Jost Langhorst
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single
Intervention model description
Parallel Assignment, Sham- and treatmentgroup
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS) | 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
| Measure | Time frame | Description |
|---|---|---|
| marital status | Week 0 | identification of marital status |
| Pain Diary | Week -2-0 | Pain diary measuring the daily pain level at baseline. It also includes medication intakes, accompanying treatments and space for additional comments. |
| sex | Week 0 | identification of gender |
| height | Week 0 | in meters |
| weight | Week 0 | in kg |
| education | Week 0 | identification of the educational level |
| job | Week 0 | 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) | Week 0 | A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects. |
| SF-36 health survey | Week 0 | 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) | Week 0 | 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) | Week 12 | 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 | Week 12 | 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) | Week 1-3 | Description of adverse events during the interventions by therapists. |
| Multidimensionl Fatigue Inventory (MFI-20) | Week 0 | 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) | Week 0 | 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) | Week 0 | 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 | Week 4 | One question about the patients global impression of change due to the therapy ranging from 1 (very much improved) to 7 (very much worse). |
| Additional Treatments/Change of Medication | Week 12 | Record of additional treatments/change of medication to control for effects. |
| Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D) | Week 0 | 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 | Week 0 | age in years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood count | Week 0 | (to measure baseline status) |
| C-reactive Protein (CRP) | Week 0 | Level of c-reactive protein (CRP) in blood to measure inflammation. |
| Tumor Necrosis Factor (TNF-α) | Week 0 | Serum parameter. |
| Blood cell sedimenation rate (BSG) | Week 0 | Serum parameter. |
| Interleukin-1 (IL-1) | Week 0 | Serum parameter (Zytokines). |
| Interleukin-8 (IL-8) | Week 0 | Serum parameter (Zytokines). |
| Interleukin-10 (IL-10) | Week 0 | Serum parameter (Zytokines). |
| creatinine | Week 4 | Serum parameter. |
| GOT, GPT, GGT | Week 4 | Serum Parameters - Liver enzymes. |
| Interleukin-6 (IL-6) | Week 0 | Serum parameter (Zytokines). |
| Coagulation | Week 0 | Coagulation measured in blood. |
Countries
Germany
Outcome results
None listed