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Completed

NCT Number: NCT05135936

Hyperthermia in 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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sozialstiftung Bamberg, Klinik für Intergrative Medizin

Bamberg, Bavaria, 96049, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sham-Group

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Multidimensionl Fatigue Inventory (MFI-20)

    Time frame: Week 0

    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).

  2. Multidimensionl Fatigue Inventory (MFI-20)

    Time frame: Week 4

    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).

  3. Multidimensionl Fatigue Inventory (MFI-20)

    Time frame: Week 12

    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).

  4. Multidimensionl Fatigue Inventory (MFI-20)

    Time frame: 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).

  5. Pittsburgh Sleep quality index (PSQI)

    Time frame: Week 0

    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.

  6. Pittsburgh Sleep quality index (PSQI)

    Time frame: Week 4

    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.

  7. Pittsburgh Sleep quality index (PSQI)

    Time frame: Week 12

    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.

  8. Pittsburgh Sleep quality index (PSQI)

    Time frame: 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.

  9. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: Week 0

    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.

  10. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: Week 4

    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.

  11. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: Week 12

    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.

  12. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: 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.

  13. Patient Global Impression of Change

    Time frame: Week 4

    One question about the patients global impression of change due to the therapy ranging from 1 (very much improved) to 7 (very much worse).

  14. Patient Global Impression of Change

    Time frame: Week 12

    One question about the patients global impression of change due to the therapy ranging from 1 (very much improved) to 7 (very much worse).

  15. Patient Global Impression of Change

    Time frame: 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).

  16. Pain Diary

    Time frame: Week -2-0

    Pain diary measuring the daily pain level at baseline. It also includes medication intakes, accompanying treatments and space for additional comments.

  17. Pain Diary

    Time frame: 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.

  18. Additional Treatments/Change of Medication

    Time frame: Week 12

    Record of additional treatments/change of medication to control for effects.

  19. Additional Treatments/Change of Medication

    Time frame: Week 30

    Record of additional treatments/change of medication to control for effects.

  20. Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)

    Time frame: Week 0

    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).

  21. Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)

    Time frame: Week 4

    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).

  22. Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)

    Time frame: Week 12

    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).

  23. Short-Form Mc Gill Pain Questionnaire - Deutsche Version (SF-MPQ-D)

    Time frame: 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).

  24. age

    Time frame: Week 0

    age in years

  25. sex

    Time frame: Week 0

    identification of gender

  26. height

    Time frame: Week 0

    in meters

  27. weight

    Time frame: Week 0

    in kg

  28. marital status

    Time frame: Week 0

    identification of marital status

  29. education

    Time frame: Week 0

    identification of the educational level

  30. job

    Time frame: Week 0

    identification of the current job (4 questions about job/application for pension)

  31. G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)

    Time frame: Week 0

    A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.

  32. G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)

    Time frame: Week 4

    A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.

  33. G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)

    Time frame: Week 12

    A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.

  34. G-EEE (Generic Rating for Treatment pre-experiences, Treatment Expectations and Treatment effects)

    Time frame: Week 30

    A non validated inventory including 11 items measuring pre-experiences, treatment expectations and treatment effects.

  35. SF-36 health survey

    Time frame: Week 0

    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.

  36. SF-36 health survey

    Time frame: Week 4

    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.

  37. SF-36 health survey

    Time frame: Week 12

    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.

  38. SF-36 health survey

    Time frame: 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.

  39. Shortform of PHQ-D (Patient Health Questionnaire)

    Time frame: Week 0

    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).

  40. Shortform of PHQ-D (Patient Health Questionnaire)

    Time frame: Week 4

    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).

  41. Shortform of PHQ-D (Patient Health Questionnaire)

    Time frame: Week 12

    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).

  42. Shortform of PHQ-D (Patient Health Questionnaire)

    Time frame: 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).

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

    Time frame: Week 12

    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.

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

    Time frame: 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.

  45. Patient Interview

    Time frame: 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).

  46. Adverse events (AE)

    Time frame: Week 1-3

    Description of adverse events during the interventions by therapists.

Other outcomes

  1. Blood count

    Time frame: Week 0

    (to measure baseline status)

  2. Blood count

    Time frame: Week 3 - after last intervention

    (to measure acute effects)

  3. Blood count

    Time frame: Week 4

    (to measure acute effects)

  4. C-reactive Protein (CRP)

    Time frame: Week 0

    Level of c-reactive protein (CRP) in blood to measure inflammation.

  5. C-reactive Protein (CRP)

    Time frame: Week 3 - after last intervention

    Level of c-reactive protein (CRP) in blood to measure inflammation (to measure acute effects).

  6. C-reactive Protein (CRP)

    Time frame: Week 4

    Level of c-reactive protein (CRP) in blood to measure inflammation.

  7. Blood cell sedimenation rate (BSG)

    Time frame: Week 0

    Serum parameter.

  8. Blood cell sedimenation rate (BSG)

    Time frame: Week 3 - after last intervention

    Serum parameter (to measure acute effects).

  9. Blood cell sedimenation rate (BSG)

    Time frame: Week 4

    Serum parameter.

  10. Coagulation

    Time frame: Week 0

    Coagulation measured in blood.

  11. Coagulation

    Time frame: Week 3 - after last intervention

    Coagulation measured in blood.

  12. Coagulation

    Time frame: Week 4

    Coagulation measured in blood.

  13. Tumor Necrosis Factor (TNF-α)

    Time frame: Week 0

    Serum parameter.

  14. Tumor Necrosis Factor (TNF-α)

    Time frame: Week 3 - after last intervention

    Serum parameter.

  15. Tumor Necrosis Factor (TNF-α)

    Time frame: Week 4

    Serum parameter.

  16. Interleukin-1 (IL-1)

    Time frame: Week 0

    Serum parameter (Zytokines).

  17. Interleukin-1 (IL-1)

    Time frame: Week 3 - after last intervention

    Serum parameter (Zytokines).

  18. Interleukin-1 (IL-1)

    Time frame: Week 4

    Serum parameter (Zytokines).

  19. Interleukin-6 (IL-6)

    Time frame: Week 0

    Serum parameter (Zytokines).

  20. Interleukin-6 (IL-6)

    Time frame: Week 3 - after last intervention

    Serum parameter (Zytokines).

  21. Interleukin-6 (IL-6)

    Time frame: Week 4

    Serum parameter (Zytokines).

  22. Interleukin-8 (IL-8)

    Time frame: Week 0

    Serum parameter (Zytokines).

  23. Interleukin-8 (IL-8)

    Time frame: Week 3 - after last intervention

    Serum parameter (Zytokines).

  24. Interleukin-8 (IL-8)

    Time frame: Week 4

    Serum parameter (Zytokines).

  25. Interleukin-10 (IL-10)

    Time frame: Week 0

    Serum parameter (Zytokines).

  26. Interleukin-10 (IL-10)

    Time frame: Week 3 - after last intervention

    Serum parameter (Zytokines).

  27. Interleukin-10 (IL-10)

    Time frame: Week 4

    Serum parameter (Zytokines).

  28. creatinine

    Time frame: Week 4

    Serum parameter.

  29. GOT, GPT, GGT

    Time frame: Week 4

    Serum Parameters - Liver enzymes.

Sponsors and collaborators

Lead sponsor

Jost Langhorst

Other

Registry information

Official study 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

Acronym: HYPAIN

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 26, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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