Hyperthermia in Fibromyalgia Syndrome

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT05135936
• Lead Sponsor: Jost Langhorst

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 Timeline

• Study Start: 2020-11-12
• Study First Submitted: 2021-04-13
• Primary Completion: 2021-04-19
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-26
• Study Completion: 2021-12-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)	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.

Secondary Outcome Measures

Name	Time	Method
Multidimensionl Fatigue Inventory (MFI-20)	Week 30	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).
Fibromyalgia Impact Questionnaire (FIQ)	Week 30	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.
Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)	Week 30	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).
SF-36 health survey	Week 30	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.
Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS)	Week 30	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.
Pittsburgh Sleep quality index (PSQI)	Week 30	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.
Additional Treatments/Change of Medication	Week 30	Record of additional treatments/change of medication to control for effects.
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)	Week 30	A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.
Patient Global Impression of Change	Week 30	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	Week 1-3	Pain diary measuring the daily pain level during the period of intervention. It also includes medication intakes, accompanying treatments and space for additional comments.
weight	Week 0	in kg
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).
marital status	Week 0	identification of marital status
education	Week 0	identification of the educational level
job	Week 0	identification of the current job (4 questions about job/application for pension)
Adverse events (AE)	Week 1-3	Description of adverse events during the interventions by therapists.
Shortform of PHQ-D (Patient Health Questionnaire)	Week 30	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).
sex	Week 0	identification of gender
age	Week 0	age in years
height	Week 0	in meters

Trial Locations

Locations (1)

Sozialstiftung Bamberg, Klinik für Intergrative Medizin; 🇩🇪 Bamberg, Bayern, Germany