Hyperthermia in Fibromyalgia Syndrome

NCT05135936 | Completed DMC

• 1 other identifier: 20079
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

hyperthermia; fibromyalgia syndrome; pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (46)

• Multidimensionl Fatigue Inventory (MFI-20)

  Week 0

• Multidimensionl Fatigue Inventory (MFI-20)

  Week 4

• Multidimensionl Fatigue Inventory (MFI-20)

  Week 12

• Multidimensionl Fatigue Inventory (MFI-20)

  Week 30

• Pittsburgh Sleep quality index (PSQI)

  Week 0

Other Outcomes (29)

• Blood count

  Week 0

• Blood count

  Week 3 - after last intervention

• Blood count

  Week 4

Study Arms (2)

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.

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.

Behavioral: Sham-Group

Interventions

Hyperthermia Group BEHAVIORAL

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.

Hyperthermia Group

Sham-Group BEHAVIORAL

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

Sham-Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jost Langhorst: lead

Study Sites (1)

Sozialstiftung Bamberg, Klinik für Intergrative Medizin

Bamberg, Bavaria, 96049, Germany

Location

MeSH Terms

Conditions

Fibromyalgia; Hyperthermia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Neurologic Manifestations

Study Officials

• Jost Langhorst, Prof.

  Sozialstiftung Bamberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: Parallel Assignment, Sham- and treatmentgroup

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: November 26, 2021
• Study Start: November 12, 2020
• Primary Completion: April 19, 2021
• Study Completion: December 13, 2021
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)