NCT03300635

Metabolism, Muscle Function and Psychological Factors in Fibromyalgia

Completed NA Last updated 13 December 2019

What this trial tests

NA trial testing Mental distress and relaxation test in Fibromyalgia in 81 participants. Completed in 10 April 2019.

Timeline

5 September 2015

Primary endpoint
10 April 2019

10 April 2019

Quick facts

Lead sponsor	Helsinki University Central Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	81
Start date	5 September 2015
Primary completion	10 April 2019
Estimated completion	10 April 2019
Sites	1 location across Finland

Drugs / interventions tested

• Mental distress and relaxation test
• Glucose tolerance test
• Exercise test

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Helsinki University Central Hospital

Who can join

Adults 18 to 65, female only, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Muscle activity and acute stress in fibromyalgia.
   Zetterman T, Markkula R, Partanen JV, Miettinen T, et al · · 2021 · cited 21× · PMID 33583408 · DOI 10.1186/s12891-021-04013-1
2. Machine learning identifies fatigue as a key symptom of fibromyalgia reflected in tyrosine, purine, pyrimidine, and glutaminergic metabolism.
   Zetterman T, Nieminen AI, Markkula R, Kalso E, et al · · 2024 · cited 13× · PMID 38411371 · DOI 10.1111/cts.13740
3. Heart rate variability responses to cognitive stress in fibromyalgia are characterised by inadequate autonomous system stress responses: a clinical trial.
   Zetterman T, Markkula R, Miettinen T, Kalso E. · · 2023 · cited 12× · PMID 36639565 · DOI 10.1038/s41598-023-27581-9
4. Elevated highly sensitive C-reactive protein in fibromyalgia associates with symptom severity.
   Zetterman T, Markkula R, Kalso E. · · 2022 · cited 11× · PMID 35832286 · DOI 10.1093/rap/rkac053
5. Glucose tolerance in fibromyalgia.
   Zetterman T, Markkula R, Kalso E. · · 2021 · cited 10× · PMID 34797307 · DOI 10.1097/md.0000000000027803
6. Cardiac output and arteriovenous oxygen difference contribute to lower peak oxygen uptake in patients with fibromyalgia.
   Lehto T, Zetterman T, Markkula R, Arokoski J, et al · · 2023 · cited 4× · PMID 37393269 · DOI 10.1186/s12891-023-06589-2
7. Muscle and cerebral oxygenation during exercise in fibromyalgia: a near-infrared spectroscopy study.
   Lehto T, Zetterman T, Gagnon D, Markkula R, et al · · 2026 · PMID 41065862 · DOI 10.1007/s00421-025-06013-8