Metabolism, Muscle Function and Psychological Factors in Fibromyalgia
NCT ID: NCT03300635
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2015-09-05
2019-04-10
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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
Mental distress and relaxation test
Glucose tolerance test
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
Mental distress and relaxation test
Glucose tolerance test
Exercise test
Interventions
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Mental distress and relaxation test
Glucose tolerance test
Exercise test
Eligibility Criteria
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Inclusion Criteria
* Finnish as native language
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
Yes
Sponsors
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University of Helsinki
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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Ritva Markkula
Principal Investigator, specialist doctor
Principal Investigators
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Eija A Kalso, MD, PhD
Role: STUDY_CHAIR
Helsinki University Hospital and Helsinki University
Locations
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HelsinkiUCH
Helsinki, , Finland
Countries
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References
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Lehto T, Zetterman T, Gagnon D, Markkula R, Arokoski J, Kalso E, Peltonen JE. Muscle and cerebral oxygenation during exercise in fibromyalgia: a near-infrared spectroscopy study. Eur J Appl Physiol. 2025 Oct 9. doi: 10.1007/s00421-025-06013-8. Online ahead of print.
Lehto T, Zetterman T, Markkula R, Arokoski J, Tikkanen H, Kalso E, Peltonen JE. Cardiac output and arteriovenous oxygen difference contribute to lower peak oxygen uptake in patients with fibromyalgia. BMC Musculoskelet Disord. 2023 Jul 1;24(1):541. doi: 10.1186/s12891-023-06589-2.
Zetterman T, Markkula R, Miettinen T, Kalso E. Heart rate variability responses to cognitive stress in fibromyalgia are characterised by inadequate autonomous system stress responses: a clinical trial. Sci Rep. 2023 Jan 13;13(1):700. doi: 10.1038/s41598-023-27581-9.
Zetterman T, Markkula R, Kalso E. Elevated highly sensitive C-reactive protein in fibromyalgia associates with symptom severity. Rheumatol Adv Pract. 2022 Jun 25;6(2):rkac053. doi: 10.1093/rap/rkac053. eCollection 2022.
Zetterman T, Markkula R, Kalso E. Glucose tolerance in fibromyalgia. Medicine (Baltimore). 2021 Nov 19;100(46):e27803. doi: 10.1097/MD.0000000000027803.
Zetterman T, Markkula R, Partanen JV, Miettinen T, Estlander AM, Kalso E. Muscle activity and acute stress in fibromyalgia. BMC Musculoskelet Disord. 2021 Feb 14;22(1):183. doi: 10.1186/s12891-021-04013-1.
Other Identifiers
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TYH2017215
Identifier Type: -
Identifier Source: org_study_id