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Metabolism, Muscle Function and Psychological Factors in Fibromyalgia

Metaboliset Muutokset ja Lihastoiminta Fibromyalgiassa

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03300635
Enrollment
81
Registered
2017-10-03
Start date
2015-09-05
Completion date
2019-04-10
Last updated
2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

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.

Interventions

OTHERMental distress and relaxation test
OTHERExercise test

Sponsors

University of Helsinki
CollaboratorOTHER
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
metabolomicsup to day 3the difference of value distribution in metabolics panel between groups
metabolomics (physical stress)Day 3 (at the end of Exercise test)the difference of value distribution in metabolics panel between groups
metabolomics (metabolic stress)Day 2 ( at the end of Glucose test)the difference of value distribution in metabolics panel between groups
muscle function (raw)Day 1sEMG signal amplitude
muscle function (normalized)Day 1normalized signal amplitude (%sEMGmax)
muscle rest timeDay 1time of sEMG signal amplitude \< 0.5% sEMGmax

Secondary

MeasureTime frameDescription
Pain intensity during mental stress vs. relaxation (baseline)Day 1 ( at the beginning of the recording during the Mental distress and relaxation test)reported pain intensity (NRS)
Pain intensity during mental stress vs. relaxation (relaxation I)Day 1 ( after the first relaxation phase of the Mental distress and relaxation test)reported pain intensity (NRS)
Pain intensity during mental stress vs. relaxation (mental stress I)Day 1 ( after the first mental stress phase of the Mental distress and relaxation test)reported pain intensity (NRS)
Perceived distress during mental stress vs. relaxation (baseline)Day 1 ( at the beginning of the recording during the Mental distress and relaxation test)reported distress intensity (NRS)
Pain intensity during mental stress vs. relaxation (mental stress II)Day 1 (after the second mental stress phase of the Mental distress and relaxation test)reported pain intensity (NRS)
Pain intensity during mental stress vs. relaxation (relaxation III)Day 1 (after the third relaxation phase of the Mental distress and relaxation test)reported pain intensity (NRS)
heart rate variabilityDay 1variability of heart beat interval evaluated as root mean square successive difference (RMSSD)
Pain intensity during mental stress vs. relaxation (relaxation II)Day 1 (after the second relaxation phase of the Mental distress and relaxation test)reported pain intensity (NRS)
Perceived distress during mental stress vs. relaxation (relaxation I)Day 1 (after the first relaxation phase of the Mental distress and relaxation test)reported distress intensity (NRS)
Perceived distress during mental stress vs. relaxation (mental stress I)Day 1 (after the first mental stress phase of the Mental distress and relaxation test)reported distress intensity (NRS)
Perceived distress during mental stress vs. relaxation (relaxation II)Day 1 (after the second relaxation phase of the Mental distress and relaxation test)reported distress intensity (NRS)
Perceived distress during mental stress vs. relaxation (mental stress II)Day 1 (after the second mental stress phase of the Mental distress and relaxation test)reported distress intensity (NRS)
Perceived distress during mental stress vs. relaxation (relaxation III)Day 1 ( after the third relaxation phase of the Mental distress and relaxation test)reported distress intensity (NRS)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026