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Completed

NCT Number: NCT03300635

Metabolism, Muscle Function and Psychological Factors in Fibromyalgia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HelsinkiUCH

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Mental distress and relaxation test

Other

Glucose tolerance test

Other

Exercise test

Other

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • University of Helsinki

Registry information

Official study title

Metaboliset Muutokset ja Lihastoiminta Fibromyalgiassa

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2017
Registry last updated
Dec 13, 2019

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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