The Role of Epigenetic Mechanisms in Stress Intolerance in Patients With Chronic Widespread Pain

NCT06475859 | Completed

• 1 other identifier: EC-2022-118
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic widespread pain (CWP) frequently experience stress intolerance - an exacerbation of symptoms in response to stress. Although it severely affects their quality of life, stress intolerance remains a mystery. Hence, unravelling the mechanisms underlying stress intolerance is crucial to understand CWP pathophysiology and to develop novel treatments. Epigenetic mechanisms hold the potential to provide an answer as they have been found to be altered in patients with CWP at baseline, and in response to stress. However, research on epigenetic mechanisms in CWP is very scarce. Hence, this study aims to address this knowledge gap by assessing stress-induced epigenetic changes in patients with CWP and healthy controls aiming to unravel whether epigenetic mechanisms can help explain stress intolerance. The regulatory role of epigenetic mechanisms will be researched in relation to the activity of enzymes affected by the epigenetic mechanisms, neurophysiological measures, and stress-induced symptom changes in patients with CWP.

Conditions

Chronic Widespread Pain

Keywords

Chronic Widespread Pain; Epigenetics; Autonomic Nervous System; Stress Intolerance

Outcome Measures

Primary Outcomes (1)

• DNA methylation of catecholamine-degrading enzymes

  DNA methylation status of catechol-O-methyltransferase (COMT), monoamine oxidase (MAO)-A and MAO-B

  At baseline (i.e. before the mental stress test or relaxation breathing), and 20 minutes after the mental stress test and relaxation breathing

Secondary Outcomes (6)

• Genetic variations in catecholamine-degrading enzymes

  At baseline

• Catecholamine levels

  At baseline (i.e. before the mental stress test or relaxation breathing), and 20 minutes after the mental stress test and relaxation breathing

• Heart rate variability

  Continuously starting 10 minutes before until 10 minutes after the mental stress test and relaxation breathing

• Blood pressure

  At baseline (i.e. before the mental stress test or relaxation breathing), during (3 times with 4 minutes in between) and 10 minutes after the mental stress test and relaxation breathing

• Activity of catecholamine-degrading enzymes

  At baseline (i.e. before the mental stress test or relaxation breathing), and 20 minutes after the mental stress test and relaxation breathing

Other Outcomes (2)

• Temperature and pressure pain thresholds

  At baseline (i.e. before the mental stress test or relaxation breathing), and 20 minutes after the mental stress test and relaxation breathing

• Level of stress

  At baseline (i.e. before the mental stress test or relaxation breathing), during (3 times with 4 minutes in between) and 10 minutes, 24 hours and 7 days after the mental stress test and relaxation breathing

Study Arms (2)

Women with chronic widespread pain

Women who received the diagnosis of fibromyalgia from a doctor.

Other: Montreal Imaging Stress Test; Other: Relaxation breathing

Healthy women

Healthy women without any chronic diseases or pain in daily life.

Other: Montreal Imaging Stress Test; Other: Relaxation breathing

Interventions

Montreal Imaging Stress Test OTHER

A mental stress test that induces stress via a series of arithmetic tasks participants need to solve in a few seconds.

Healthy women; Women with chronic widespread pain

Relaxation breathing OTHER

3 short sessions (4 minutes) of relaxation breathing

Healthy women; Women with chronic widespread pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential study participants will be recruited mainly through online advertisements, but also in hospitals.

You may qualify if:

• female
• age between 18 and 70 years old
• body mass index (BMI) below 30
• inactive lifestyle
• for patients only: received the diagnosis of fibromyalgia

You may not qualify if:

• other neurological, endocrine, cardiac, or systemic syndromes
• history of cancer or heart failure
• women that are pregnant or within one year after pregnancy

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Research Foundation Flanders: collaborator
• KU Leuven: collaborator

Study Sites (1)

Vrije Universiteit Brussel - UZ Brussel

Brussels, Brussels Capital, 1050, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, Peripheral blood mononuclear cells (PBMC), Plasma

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jo Nijs, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 26, 2024
• Study Start: April 19, 2023
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

BE (1)