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Metabolism, Muscle Function and Psychological Factors in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03300635
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Helsinki University
Information provided by (Responsible Party):
Ritva Markkula, Helsinki University Central Hospital

Brief Summary:

Fibromyalgia (FM) is a world widely common syndrome, characterized by widespread pain, often accompanied by general fatigue, soreness, and abnormal sensations (like "pins and needles"). The reasons and the mechanisms (pathogenesis) of FM are still poorly understood. Efficacious therapies cannot be developed without understanding the pathophysiological mechanisms of the disease or syndrome.

FM patients suffer from pain and sense of weakness and fatigue in the muscles, and often report difficulty in relaxing their muscles. So far, the studies on muscle activation in fibromyalgia (mostly using surface electromyography) have shown some unusual functioning, a kind of overuse, but the results have been somewhat contradictory.

FM symptoms share some features with small fibre neuropathy, which is a disease or abnormality of small nerve fibres with a diverse aetiology. Recently, several research groups have shown (studying both the electrical function of superficial nerves and nerve endings of skin samples) that up to 50% of the FM patients with severe symptoms have small fibre neuropathy: their small nerves do not function properly and small nerve fibre density in their skin is reduced. However, as this phenomenon is common but not a rule, it might be rather a consequence of some underlying mechanisms of the syndrome, creating even more symptoms.

The aim is to investigate whether there would exist metabolic changes in FM patients that would create pain and lead to functional changes and damage in small nerve fibres. The investigators also aim to explore the muscle function particularly in distressed situations and at rest. The hypothesis is that a towards-overuse-altered function would create unfavourable metabolic changes. Third, the aim is to investigate some psychological factors (such as tendency to get anxious or distressed) to find out, if there is any association between them and muscle function.

The FM patients as well as healthy control subjects will be recruited at Helsinki University Hospital Pain Clinic and from primary care at Vantaa Health Care Centre. The voluntary test subjects will attend

  1. A muscle function examination of 30 minutes with electromyography using surface electrodes, including mentally distressing tasks and relaxing periods. At the same session, the subject will reply to some questionnaires regarding their symptoms and measuring some psychological factors. Actual pain level will be assessed.
  2. A glucose tolerance test, with other blood samples
  3. A bicycle ergometer exercise test of 20 - 30 minutes, with both physiological and chemical (blood samples) recordings. Actual pain level will be assessed as well.

At this stage, 40 patients and 20 healthy control subjects will be recruited.


Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Mental distress and relaxation test Other: Glucose tolerance test Other: Exercise test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients and healthy control subjects will attend the same interventions: a) muscle function test (distressing task vs. relaxing) with e.g. psychological questionnaires, b) glucose tolerance test and other blood analyses including metabolomics, and c) bicycle ergometry with physiological measurements and blood analyses including metabolomics.
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Metaboliset Muutokset ja Lihastoiminta Fibromyalgiassa
Actual Study Start Date : September 5, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Fibromyalgia patients
All study subjects, both patients and healthy controls, will attend all three interventions: Mental distress and relaxation test, Glucose tolerance test, and Exercise test
Other: Mental distress and relaxation test
Other: Glucose tolerance test
Other: Exercise test
Healthy controls
All study subjects, both patients and healthy controls, will attend all three interventions: Mental distress and relaxation test, Glucose tolerance test, and Exercise test
Other: Mental distress and relaxation test
Other: Glucose tolerance test
Other: Exercise test



Primary Outcome Measures :
  1. metabolomics [ Time Frame: up to day 3 ]
    the difference of value distribution in metabolics panel between groups

  2. metabolomics (physical stress) [ Time Frame: Day 3 (at the end of Exercise test) ]
    the difference of value distribution in metabolics panel between groups

  3. metabolomics (metabolic stress) [ Time Frame: Day 2 ( at the end of Glucose test) ]
    the difference of value distribution in metabolics panel between groups

  4. muscle function (raw) [ Time Frame: Day 1 ]
    sEMG signal amplitude

  5. muscle function (normalized) [ Time Frame: Day 1 ]
    normalized signal amplitude (%sEMGmax)

  6. muscle rest time [ Time Frame: Day 1 ]
    time of sEMG signal amplitude < 0.5% sEMGmax


Secondary Outcome Measures :
  1. Perceived distress during mental stress vs. relaxation (baseline) [ Time Frame: Day 1 ( at the beginning of the recording during the Mental distress and relaxation test) ]
    reported distress intensity (NRS)

  2. Perceived distress during mental stress vs. relaxation (relaxation I) [ Time Frame: Day 1 (after the first relaxation phase of the Mental distress and relaxation test) ]
    reported distress intensity (NRS)

  3. Perceived distress during mental stress vs. relaxation (mental stress I) [ Time Frame: Day 1 (after the first mental stress phase of the Mental distress and relaxation test) ]
    reported distress intensity (NRS)

  4. Perceived distress during mental stress vs. relaxation (relaxation II) [ Time Frame: Day 1 (after the second relaxation phase of the Mental distress and relaxation test) ]
    reported distress intensity (NRS)

  5. Perceived distress during mental stress vs. relaxation (mental stress II) [ Time Frame: Day 1 (after the second mental stress phase of the Mental distress and relaxation test) ]
    reported distress intensity (NRS)

  6. Perceived distress during mental stress vs. relaxation (relaxation III) [ Time Frame: Day 1 ( after the third relaxation phase of the Mental distress and relaxation test) ]
    reported distress intensity (NRS)

  7. Pain intensity during mental stress vs. relaxation (baseline) [ Time Frame: Day 1 ( at the beginning of the recording during the Mental distress and relaxation test) ]
    reported pain intensity (NRS)

  8. Pain intensity during mental stress vs. relaxation (relaxation I) [ Time Frame: Day 1 ( after the first relaxation phase of the Mental distress and relaxation test) ]
    reported pain intensity (NRS)

  9. Pain intensity during mental stress vs. relaxation (mental stress I) [ Time Frame: Day 1 ( after the first mental stress phase of the Mental distress and relaxation test) ]
    reported pain intensity (NRS)

  10. Pain intensity during mental stress vs. relaxation (relaxation II) [ Time Frame: Day 1 (after the second relaxation phase of the Mental distress and relaxation test) ]
    reported pain intensity (NRS)

  11. Pain intensity during mental stress vs. relaxation (mental stress II) [ Time Frame: Day 1 (after the second mental stress phase of the Mental distress and relaxation test) ]
    reported pain intensity (NRS)

  12. Pain intensity during mental stress vs. relaxation (relaxation III) [ Time Frame: Day 1 (after the third relaxation phase of the Mental distress and relaxation test) ]
    reported pain intensity (NRS)

  13. heart rate variability [ Time Frame: Day 1 ]
    variability of heart beat interval evaluated as root mean square successive difference (RMSSD)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The Finnish personal ID system includes identification of gender. As most of clinical FM patients are women, we exclude men to create as much homogenity as possible in our sample.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • fibromyalgia diagnosed by the researchers RM or TZ, based on the ACR criteria from 1990
  • Finnish as native language

Exclusion Criteria:

  • male sex
  • muscular or neuromuscular diseases
  • diabetes
  • heart disease
  • generalised atherosclerosis
  • untreated hypertension
  • neurological or other disease that systematically affects muscles
  • a severe psychiatric disorder
  • regular consumption of beta-blockers, bronchodilators, or statins

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300635


Contacts
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Contact: Ritva A Markkula, MD, PhD +358-9-47175640 ritva.markkula@hus.fi
Contact: Teemu Zetterman, MD teemu.zetterman@helsinki.fi

Locations
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Finland
HelsinkiUCH Recruiting
Helsinki, Finland
Contact: Ritva Markkula, MD, PhD       ritva.markkula@hus.fi   
Contact: Teemu Zetterman, MD       teemu.zetterman@helsinki.fi   
Sponsors and Collaborators
Helsinki University Central Hospital
Helsinki University
Investigators
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Study Chair: Eija A Kalso, MD, PhD Helsinki University Hospital and Helsinki University

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Responsible Party: Ritva Markkula, Principal Investigator, specialist doctor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03300635     History of Changes
Other Study ID Numbers: TYH2017215
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data are available for only two of the researchers, Ritva Markkula and Teemu Zetterman, who are recruiting the subjects and collecting and coding their personal data to an unidentified mode.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases