Metabolism, Muscle Function and Psychological Factors in Fibromyalgia

NCT03300635 | Completed

• 1 other identifier: TYH2017215
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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. 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. 2.A glucose tolerance test, with other blood samples
3. 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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (13)

• Perceived distress during mental stress vs. relaxation (baseline)

  Day 1 ( at the beginning of the recording during the Mental distress and relaxation test)

• Perceived distress during mental stress vs. relaxation (relaxation I)

  Day 1 (after the first relaxation phase of the Mental distress and relaxation test)

• 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)

• Perceived distress during mental stress vs. relaxation (relaxation II)

  Day 1 (after the second relaxation phase of the Mental distress and relaxation test)

• 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)

Study Arms (2)

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

Other: Mental distress and relaxation test; Other: Glucose tolerance test; Other: 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

Other: Mental distress and relaxation test; Other: Glucose tolerance test; Other: Exercise test

Interventions

Mental distress and relaxation test OTHER

Fibromyalgia patients; Healthy controls

Glucose tolerance test OTHER

Fibromyalgia patients; Healthy controls

Exercise test OTHER

Fibromyalgia patients; Healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fibromyalgia diagnosed by the researchers RM or TZ, based on the ACR criteria from 1990
• Finnish as native language

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator

Study Sites (1)

HelsinkiUCH

Helsinki, Finland

Location

Related Publications (6)

• 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.

  PMID: 41065862 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.

  PMID: 37393269 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.

  PMID: 36639565 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.

  PMID: 35832286 DERIVED

• Zetterman T, Markkula R, Kalso E. Glucose tolerance in fibromyalgia. Medicine (Baltimore). 2021 Nov 19;100(46):e27803. doi: 10.1097/MD.0000000000027803.

  PMID: 34797307 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.

  PMID: 33583408 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Glucose Tolerance Test; Exercise Test

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry

Study Officials

• Eija A Kalso, MD, PhD

  Helsinki University Hospital and Helsinki University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, specialist doctor

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: October 3, 2017
• Study Start: September 5, 2015
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

FI (1)