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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
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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
At this stage, 40 patients and 20 healthy control subjects will be recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibromyalgia patients | Other | All study subjects, both patients and healthy controls, will attend all three interventions: Mental distress and relaxation test, Glucose tolerance test, and Exercise test |
|
| Healthy controls | Other | All study subjects, both patients and healthy controls, will attend all three interventions: Mental distress and relaxation test, Glucose tolerance test, and Exercise test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mental distress and relaxation test | Other |
| ||
| Glucose tolerance test |
| Measure | Description | Time Frame |
|---|---|---|
| metabolomics | the difference of value distribution in metabolics panel between groups | up to day 3 |
| metabolomics (physical stress) | the difference of value distribution in metabolics panel between groups | Day 3 (at the end of Exercise test) |
| metabolomics (metabolic stress) | the difference of value distribution in metabolics panel between groups | Day 2 ( at the end of Glucose test) |
| muscle function (raw) | sEMG signal amplitude | Day 1 |
| muscle function (normalized) | normalized signal amplitude (%sEMGmax) | Day 1 |
| muscle rest time | time of sEMG signal amplitude < 0.5% sEMGmax | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived distress during mental stress vs. relaxation (baseline) | reported distress intensity (NRS) | Day 1 ( at the beginning of the recording during the Mental distress and relaxation test) |
| Perceived distress during mental stress vs. relaxation (relaxation I) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Eija A Kalso, MD, PhD | Helsinki University Hospital and Helsinki University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HelsinkiUCH | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41065862 | Derived | 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. 2026 Mar;126(3):1723-1735. doi: 10.1007/s00421-025-06013-8. Epub 2025 Oct 9. | |
| 37393269 | Derived | 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. |
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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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 8, 2024 | |
| Reset | Aug 15, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 8, 2024 | Aug 15, 2024 |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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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.
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| Other |
|
| Exercise test | Other |
|
reported distress intensity (NRS) |
| Day 1 (after the first relaxation phase of the Mental distress and relaxation test) |
| Perceived distress during mental stress vs. relaxation (mental stress I) | reported distress intensity (NRS) | Day 1 (after the first mental stress phase of the Mental distress and relaxation test) |
| Perceived distress during mental stress vs. relaxation (relaxation II) | reported distress intensity (NRS) | Day 1 (after the second relaxation phase of the Mental distress and relaxation test) |
| Perceived distress during mental stress vs. relaxation (mental stress II) | reported distress intensity (NRS) | Day 1 (after the second mental stress phase of the Mental distress and relaxation test) |
| Perceived distress during mental stress vs. relaxation (relaxation III) | reported distress intensity (NRS) | Day 1 ( after the third relaxation phase of the Mental distress and relaxation test) |
| Pain intensity during mental stress vs. relaxation (baseline) | reported pain intensity (NRS) | Day 1 ( at the beginning of the recording during the Mental distress and relaxation test) |
| Pain intensity during mental stress vs. relaxation (relaxation I) | reported pain intensity (NRS) | Day 1 ( after the first relaxation phase of the Mental distress and relaxation test) |
| Pain intensity during mental stress vs. relaxation (mental stress I) | reported pain intensity (NRS) | Day 1 ( after the first mental stress phase of the Mental distress and relaxation test) |
| Pain intensity during mental stress vs. relaxation (relaxation II) | reported pain intensity (NRS) | Day 1 (after the second relaxation phase of the Mental distress and relaxation test) |
| Pain intensity during mental stress vs. relaxation (mental stress II) | reported pain intensity (NRS) | Day 1 (after the second mental stress phase of the Mental distress and relaxation test) |
| Pain intensity during mental stress vs. relaxation (relaxation III) | reported pain intensity (NRS) | Day 1 (after the third relaxation phase of the Mental distress and relaxation test) |
| heart rate variability | variability of heart beat interval evaluated as root mean square successive difference (RMSSD) | Day 1 |
| 36639565 | Derived | 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. |
| 35832286 | Derived | 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. |
| 34797307 | Derived | Zetterman T, Markkula R, Kalso E. Glucose tolerance in fibromyalgia. Medicine (Baltimore). 2021 Nov 19;100(46):e27803. doi: 10.1097/MD.0000000000027803. |
| 33583408 | Derived | 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. |
| D009422 |
| Nervous System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |