Hyperthermia in Fibromyalgia Syndrome

A study testing Hyperthermia Group in people with Fibromyalgia, run by Jost Langhorst at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Fibromyalgia
What is being tested?: Hyperthermia Group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 1 siteGermany
Study dates: 12 Nov 2020to 13 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

confirmed diagnosis of fibromyalgia (FSQ)
Pain VAS >= 4,0
Signed declaration of consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Bamberg, Bavaria, 96049

Other trials in Germany

About this study

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

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.

Read the 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.

Conditions: Fibromyalgia
Being tested: Hyperthermia Group, Sham-Group
Keywords: hyperthermia, fibromyalgia syndrome, pain
Medical subject headings: Fibromyalgia, Hyperthermia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyperthermia GroupBehavioural
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-GroupBehavioural
The number of treatments is equal to the number of treatments in the intervention group.

Study groups in NCT05135936
Study group	Role	What they receive
Hyperthermia Group	Experimental	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. Receives: Behavioral: Hyperthermia Group
Sham-Group	Sham comparator	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. Receives: Behavioral: Sham-Group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 0
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.
Measured: Week 4

Secondary outcomes (46)

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).
Measured: Week 0
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).
Measured: Week 4
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).
Measured: Week 12
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).
Measured: Week 30
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.
Measured: Week 0
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.
Measured: Week 4
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.
Measured: Week 12
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.
Measured: Week 30
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.
Measured: Week 0
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.
Measured: Week 4
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.
Measured: Week 12
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.
Measured: Week 30
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).
Measured: Week 4
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).
Measured: Week 12
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).
Measured: Week 30
Pain Diary
Pain diary measuring the daily pain level at baseline. It also includes medication intakes, accompanying treatments and space for additional comments.
Measured: Week -2-0
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.
Measured: Week 1-3
Additional Treatments/Change of Medication
Record of additional treatments/change of medication to control for effects.
Measured: Week 12
Additional Treatments/Change of Medication
Record of additional treatments/change of medication to control for effects.
Measured: Week 30
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).
Measured: Week 0
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).
Measured: Week 4
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).
Measured: Week 12
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).
Measured: Week 30
age
age in years
Measured: Week 0
sex
identification of gender
Measured: Week 0
height
in meters
Measured: Week 0
weight
in kg
Measured: Week 0
marital status
identification of marital status
Measured: Week 0
education
identification of the educational level
Measured: Week 0
job
identification of the current job (4 questions about job/application for pension)
Measured: Week 0
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.
Measured: Week 0
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.
Measured: Week 4
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.
Measured: Week 12
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.
Measured: Week 30
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.
Measured: Week 0
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.
Measured: Week 4
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.
Measured: Week 12
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.
Measured: Week 30
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).
Measured: Week 0
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).
Measured: Week 4
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).
Measured: Week 12
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).
Measured: Week 30
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.
Measured: Week 12
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.
Measured: Week 30
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).
Measured: Week 12
Adverse events (AE)
Description of adverse events during the interventions by therapists.
Measured: Week 1-3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 202013 Dec 2021

First posted26 Nov 2021
Study start12 Nov 2020
Primary completion19 Apr 2021
Study completion13 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment, Sham- and treatmentgroup
Masking: Single blind
Who is masked: Participant
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05135936
Sponsor's protocol ID: 20079
Acronym: HYPAIN
Status last verified: Nov 2023
First submitted: 13 Apr 2021
Last updated: 29 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05135936
Acronym / sponsor ID: HYPAIN / 20079
Conditions: Fibromyalgia
Keywords: hyperthermia, fibromyalgia syndrome, pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Jost LanghorstUniversity, hospital or other
Study start: 12 Nov 2020 (actual)
Primary completion: 19 Apr 2021 (actual)
Study completion: 13 Dec 2021 (actual)
First posted: 26 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Parallel Assignment, Sham- and treatmentgroup

Arm	Type	Receives
Hyperthermia Group	Experimental	Behavioral: Hyperthermia GroupFor 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.
Sham-Group	Sham comparator	Behavioral: Sham-GroupWithin 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

confirmed diagnosis of fibromyalgia (FSQ)
Pain VAS >= 4,0
Signed declaration of consent

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hyperthermia GroupThe 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.	Behavioural	Hyperthermia Group
Sham-GroupThe number of treatments is equal to the number of treatments in the intervention group.	Behavioural	Sham-Group

Primary outcome

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.
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.

46 secondary outcomes

Multidimensionl Fatigue Inventory (MFI-20)
Time frame: Week 0
Multidimensionl Fatigue Inventory (MFI-20)
Time frame: Week 4
Multidimensionl Fatigue Inventory (MFI-20)
Time frame: Week 12
Multidimensionl Fatigue Inventory (MFI-20)
Time frame: Week 30
Pittsburgh Sleep quality index (PSQI)
Time frame: Week 0
Pittsburgh Sleep quality index (PSQI)
Time frame: Week 4
Pittsburgh Sleep quality index (PSQI)
Time frame: Week 12
Pittsburgh Sleep quality index (PSQI)
Time frame: Week 30
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Week 0
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Week 4
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Week 12
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Week 30
Patient Global Impression of Change
Time frame: Week 4
Patient Global Impression of Change
Time frame: Week 12
Patient Global Impression of Change
Time frame: Week 30
Pain Diary
Time frame: Week -2-0
Pain Diary
Time frame: Week 1-3
Additional Treatments/Change of Medication
Time frame: Week 12
Additional Treatments/Change of Medication
Time frame: Week 30
Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
Time frame: Week 0
Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
Time frame: Week 4
Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
Time frame: Week 12
Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)
Time frame: Week 30
age
Time frame: Week 0
sex
Time frame: Week 0
height
Time frame: Week 0
weight
Time frame: Week 0
marital status
Time frame: Week 0
education
Time frame: Week 0
job
Time frame: Week 0
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Time frame: Week 0
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Time frame: Week 4
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Time frame: Week 12
G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)
Time frame: Week 30
SF-36 health survey
Time frame: Week 0
SF-36 health survey
Time frame: Week 4
SF-36 health survey
Time frame: Week 12
SF-36 health survey
Time frame: Week 30
Shortform of PHQ-D (Patient Health Questionnaire)
Time frame: Week 0
Shortform of PHQ-D (Patient Health Questionnaire)
Time frame: Week 4

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jost Langhorst, Prof. study director

Sozialstiftung Bamberg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hyperthermia Group in people with Fibromyalgia, run by Jost Langhorst at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Pain Inventory (BPI) - Intensity of pain (Numeric Rating Scale, NRS) (time frame: Week 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05135936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.