Clinical trial NCT05135936: Hyperthermia in Fibromyalgia Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: hyperthermia
fibromyalgia syndrome
pain
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment, Sham- and treatmentgroup
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
timeFrame: Week 0
measure: Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
timeFrame: Week 4
Secondary outcomes:
measure: Multidimensionl Fatigue Inventory (MFI-20)
timeFrame: Week 0
measure: Multidimensionl Fatigue Inventory (MFI-20)
timeFrame: Week 4
measure: Multidimensionl Fatigue Inventory (MFI-20)
timeFrame: Week 12
measure: Multidimensionl Fatigue Inventory (MFI-20)
timeFrame: Week 30
measure: Pittsburgh Sleep quality index (PSQI)
timeFrame: Week 0
measure: Pittsburgh Sleep quality index (PSQI)
timeFrame: Week 4
measure: Pittsburgh Sleep quality index (PSQI)
timeFrame: Week 12
measure: Pittsburgh Sleep quality index (PSQI)
timeFrame: Week 30
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Week 0
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Week 4
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Week 12
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Week 30
measure: Patient Global Impression of Change
timeFrame: Week 4
measure: Patient Global Impression of Change
timeFrame: Week 12
measure: Patient Global Impression of Change
timeFrame: Week 30
measure: Pain Diary
timeFrame: Week -2-0
measure: Pain Diary
timeFrame: Week 1-3
measure: Additional Treatments/Change of Medication
timeFrame: Week 12
measure: Additional Treatments/Change of Medication
timeFrame: Week 30
measure: Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
timeFrame: Week 0
measure: Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
timeFrame: Week 4
measure: Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
timeFrame: Week 12
measure: Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
timeFrame: Week 30
measure: age
timeFrame: Week 0
measure: sex
timeFrame: Week 0
measure: height
timeFrame: Week 0
measure: weight
timeFrame: Week 0
measure: marital status
timeFrame: Week 0
measure: education
timeFrame: Week 0
measure: job
timeFrame: Week 0
measure: G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
timeFrame: Week 0
measure: G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
timeFrame: Week 4
measure: G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
timeFrame: Week 12
measure: G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
timeFrame: Week 30
measure: SF-36 health survey
timeFrame: Week 0
measure: SF-36 health survey
timeFrame: Week 4
measure: SF-36 health survey
timeFrame: Week 12
measure: SF-36 health survey
timeFrame: Week 30
measure: Shortform of PHQ-D (Patient Health Questionnaire)
timeFrame: Week 0
measure: Shortform of PHQ-D (Patient Health Questionnaire)
timeFrame: Week 4
measure: Shortform of PHQ-D (Patient Health Questionnaire)
timeFrame: Week 12
measure: Shortform of PHQ-D (Patient Health Questionnaire)
timeFrame: Week 30
measure: Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
timeFrame: Week 12
measure: Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)
timeFrame: Week 30
measure: Patient Interview
timeFrame: Week 12
measure: Adverse events (AE)
timeFrame: Week 1-3
Other outcomes:
measure: Blood count
timeFrame: Week 0
measure: Blood count
timeFrame: Week 3 - after last intervention
measure: Blood count
timeFrame: Week 4
measure: C-reactive Protein (CRP)
timeFrame: Week 0
measure: C-reactive Protein (CRP)
timeFrame: Week 3 - after last intervention
measure: C-reactive Protein (CRP)
timeFrame: Week 4
measure: Blood cell sedimenation rate (BSG)
timeFrame: Week 0
measure: Blood cell sedimenation rate (BSG)
timeFrame: Week 3 - after last intervention
measure: Blood cell sedimenation rate (BSG)
timeFrame: Week 4
measure: Coagulation
timeFrame: Week 0
measure: Coagulation
timeFrame: Week 3 - after last intervention
measure: Coagulation
timeFrame: Week 4
measure: Tumor Necrosis Factor (TNF-α)
timeFrame: Week 0
measure: Tumor Necrosis Factor (TNF-α)
timeFrame: Week 3 - after last intervention
measure: Tumor Necrosis Factor (TNF-α)
timeFrame: Week 4
measure: Interleukin-1 (IL-1)
timeFrame: Week 0
measure: Interleukin-1 (IL-1)
timeFrame: Week 3 - after last intervention
measure: Interleukin-1 (IL-1)
timeFrame: Week 4
measure: Interleukin-6 (IL-6)
timeFrame: Week 0
measure: Interleukin-6 (IL-6)
timeFrame: Week 3 - after last intervention
measure: Interleukin-6 (IL-6)
timeFrame: Week 4
measure: Interleukin-8 (IL-8)
timeFrame: Week 0
measure: Interleukin-8 (IL-8)
timeFrame: Week 3 - after last intervention
measure: Interleukin-8 (IL-8)
timeFrame: Week 4
measure: Interleukin-10 (IL-10)
timeFrame: Week 0
measure: Interleukin-10 (IL-10)
timeFrame: Week 3 - after last intervention
measure: Interleukin-10 (IL-10)
timeFrame: Week 4
measure: creatinine
timeFrame: Week 4
measure: GOT, GPT, GGT
timeFrame: Week 4
Locations:
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinik für Intergrative Medizin
state: Bayern
Study officials:
affiliation: Sozialstiftung Bamberg
name: Jost Langhorst, Prof.
role: STUDY_DIRECTOR
References: