Metabolism, Muscle Function and Psychological Factors in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Metaboliset Muutokset ja Lihastoiminta Fibromyalgiassa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300635
• Other study ID #: TYH2017215
• Status: Completed
• Phase: N/A
• Start date: September 5, 2015
• Est. completion date: April 10, 2019

Study information

• Verified date: December 2019
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Mental distress and relaxation test

• Glucose tolerance test

• Exercise test

Locations

Country	Name	City	State
Finland	HelsinkiUCH	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metabolomics	the difference of value distribution in metabolics panel between groups	up to day 3
Primary	metabolomics (physical stress)	the difference of value distribution in metabolics panel between groups	Day 3 (at the end of Exercise test)
Primary	metabolomics (metabolic stress)	the difference of value distribution in metabolics panel between groups	Day 2 ( at the end of Glucose test)
Primary	muscle function (raw)	sEMG signal amplitude	Day 1
Primary	muscle function (normalized)	normalized signal amplitude (%sEMGmax)	Day 1
Primary	muscle rest time	time of sEMG signal amplitude < 0.5% sEMGmax	Day 1
Secondary	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)
Secondary	Perceived distress during mental stress vs. relaxation (relaxation I)	reported distress intensity (NRS)	Day 1 (after the first relaxation phase of the Mental distress and relaxation test)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	heart rate variability	variability of heart beat interval evaluated as root mean square successive difference (RMSSD)	Day 1