Hyperthermia in Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05135936
• Other study ID #: 20079
• Status: Completed
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: December 13, 2021

Study information

• Verified date: November 2023
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 13, 2021
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Fibromyalgia
• Hyperthermia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Hyperthermia 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.
• Sham-Group
The number of treatments is equal to the number of treatments in the intervention group.

Locations

Country	Name	City	State
Germany	Sozialstiftung Bamberg, Klinik für Intergrative Medizin	Bamberg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Jost Langhorst

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood count	(to measure baseline status)	Week 0
Other	Blood count	(to measure acute effects)	Week 3 - after last intervention
Other	Blood count	(to measure acute effects)	Week 4
Other	C-reactive Protein (CRP)	Level of c-reactive protein (CRP) in blood to measure inflammation.	Week 0
Other	C-reactive Protein (CRP)	Level of c-reactive protein (CRP) in blood to measure inflammation (to measure acute effects).	Week 3 - after last intervention
Other	C-reactive Protein (CRP)	Level of c-reactive protein (CRP) in blood to measure inflammation.	Week 4
Other	Blood cell sedimenation rate (BSG)	Serum parameter.	Week 0
Other	Blood cell sedimenation rate (BSG)	Serum parameter (to measure acute effects).	Week 3 - after last intervention
Other	Blood cell sedimenation rate (BSG)	Serum parameter.	Week 4
Other	Coagulation	Coagulation measured in blood.	Week 0
Other	Coagulation	Coagulation measured in blood.	Week 3 - after last intervention
Other	Coagulation	Coagulation measured in blood.	Week 4
Other	Tumor Necrosis Factor (TNF-a)	Serum parameter.	Week 0
Other	Tumor Necrosis Factor (TNF-a)	Serum parameter.	Week 3 - after last intervention
Other	Tumor Necrosis Factor (TNF-a)	Serum parameter.	Week 4
Other	Interleukin-1 (IL-1)	Serum parameter (Zytokines).	Week 0
Other	Interleukin-1 (IL-1)	Serum parameter (Zytokines).	Week 3 - after last intervention
Other	Interleukin-1 (IL-1)	Serum parameter (Zytokines).	Week 4
Other	Interleukin-6 (IL-6)	Serum parameter (Zytokines).	Week 0
Other	Interleukin-6 (IL-6)	Serum parameter (Zytokines).	Week 3 - after last intervention
Other	Interleukin-6 (IL-6)	Serum parameter (Zytokines).	Week 4
Other	Interleukin-8 (IL-8)	Serum parameter (Zytokines).	Week 0
Other	Interleukin-8 (IL-8)	Serum parameter (Zytokines).	Week 3 - after last intervention
Other	Interleukin-8 (IL-8)	Serum parameter (Zytokines).	Week 4
Other	Interleukin-10 (IL-10)	Serum parameter (Zytokines).	Week 0
Other	Interleukin-10 (IL-10)	Serum parameter (Zytokines).	Week 3 - after last intervention
Other	Interleukin-10 (IL-10)	Serum parameter (Zytokines).	Week 4
Other	creatinine	Serum parameter.	Week 4
Other	GOT, GPT, GGT	Serum Parameters - Liver enzymes.	Week 4
Primary	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.	Week 0
Primary	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.	Week 4
Secondary	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).	Week 0
Secondary	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).	Week 4
Secondary	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).	Week 12
Secondary	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).	Week 30
Secondary	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.	Week 0
Secondary	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.	Week 4
Secondary	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.	Week 12
Secondary	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.	Week 30
Secondary	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.	Week 0
Secondary	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.	Week 4
Secondary	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.	Week 12
Secondary	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.	Week 30
Secondary	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).	Week 4
Secondary	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).	Week 12
Secondary	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).	Week 30
Secondary	Pain Diary	Pain diary measuring the daily pain level at baseline. It also includes medication intakes, accompanying treatments and space for additional comments.	Week -2-0
Secondary	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.	Week 1-3
Secondary	Additional Treatments/Change of Medication	Record of additional treatments/change of medication to control for effects.	Week 12
Secondary	Additional Treatments/Change of Medication	Record of additional treatments/change of medication to control for effects.	Week 30
Secondary	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).	Week 0
Secondary	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).	Week 4
Secondary	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).	Week 12
Secondary	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).	Week 30
Secondary	age	age in years	Week 0
Secondary	sex	identification of gender	Week 0
Secondary	height	in meters	Week 0
Secondary	weight	in kg	Week 0
Secondary	marital status	identification of marital status	Week 0
Secondary	education	identification of the educational level	Week 0
Secondary	job	identification of the current job (4 questions about job/application for pension)	Week 0
Secondary	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.	Week 0
Secondary	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.	Week 4
Secondary	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.	Week 12
Secondary	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.	Week 30
Secondary	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.	Week 0
Secondary	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.	Week 4
Secondary	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.	Week 12
Secondary	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.	Week 30
Secondary	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).	Week 0
Secondary	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).	Week 4
Secondary	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).	Week 12
Secondary	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).	Week 30
Secondary	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.	Week 12
Secondary	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.	Week 30
Secondary	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).	Week 12
Secondary	Adverse events (AE)	Description of adverse events during the interventions by therapists.	Week 1-3