Clinical trial NCT06475859: The Role of Epigenetic Mechanisms in Stress Intolerance in Patients With Chronic Widespread Pain
Official title: The Role of Epigenetic Mechanisms in Stress Intolerance in Patients With Chronic Widespread Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Widespread Pain
Keywords: Chronic Widespread Pain
Epigenetics
Autonomic Nervous System
Stress Intolerance
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: KU Leuven
First posted: 2024-06-26
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential study participants will be recruited mainly through online advertisements, but also in hospitals.

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.

Detailed description: The objectives of this project will be tackled by a randomized cross-over study including 44 patients with CWP and 44 healthy controls. Participants are expected to come to the hospital twice and fill in questionnaires at several defined timepoints. Two days before their first visit, participants will complete baseline questionnaires at home via REDCap, which will take approximately one hour. Next, participants will be randomised into Group 1 (undergoing the mental stress test at their first visit and then relaxation breathing) or Group 2 (undergoing relaxation breathing at their first visit and then the mental stress test). During each hospital visit, the participants will be assessed before, during and after the intervention. The Pre-test assessment consists of a blood withdrawal, five short questionnaires, examination of pain thresholds, and neurophysiological measurements. The latter will continue during the intervention, which consists of a mental stress test or relaxation breathing. The Post-test assessment consists of a blood withdrawal, one short questionnaire, examination of pain thresholds, and neurophysiological measurements. Then there are again 2 home-based assessments via REDCap 24h and 7 days after the intervention during which the participants will in 1 or 5 short questionnaires, respectively.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: DNA methylation of catecholamine-degrading enzymes
timeFrame: 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:
measure: Genetic variations in catecholamine-degrading enzymes
timeFrame: At baseline
measure: Catecholamine levels
timeFrame: At baseline (i.e. before the mental stress test or relaxation breathing), and 20 minutes after the mental stress test and relaxation breathing
measure: Heart rate variability
timeFrame: Continuously starting 10 minutes before until 10 minutes after the mental stress test and relaxation breathing
measure: Blood pressure
timeFrame: 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
measure: Activity of catecholamine-degrading enzymes
timeFrame: At baseline (i.e. before the mental stress test or relaxation breathing), and 20 minutes after the mental stress test and relaxation breathing
measure: Symptom severity
timeFrame: At baseline (i.e. before the mental stress test or relaxation breathing), and 10 minutes, 24 hours and 7 days after the mental stress test and relaxation breathing
Other outcomes:
measure: Temperature and pressure pain thresholds
timeFrame: At baseline (i.e. before the mental stress test or relaxation breathing), and 20 minutes after the mental stress test and relaxation breathing
measure: Level of stress
timeFrame: 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
Locations:
city: Brussels
country: Belgium
facility: Vrije Universiteit Brussel - UZ Brussel
Study officials:
affiliation: Vrije Universiteit Brussel
name: Jo Nijs, PhD
role: PRINCIPAL_INVESTIGATOR
References: