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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
| KU Leuven | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with chronic widespread pain | Women who received the diagnosis of fibromyalgia from a doctor. |
| |
| Healthy women | Healthy women without any chronic diseases or pain in daily life. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic variations in catecholamine-degrading enzymes | COMT: rs4818; rs4680 MAO-A: rs6323; MAOA-uVNTR MAO-B: rs1799836 COMT: rs4818; rs4680 MAO-A: rs6323; MAOA-uVNTR MAO-B: rs1799836 COMT: rs4818; rs4680 MAO-A: rs6323; MAOA-uVNTR MAO-B: rs1799836 COMT: rs4818; rs4680; MAO-A: rs6323; MAOA-uVNTR; MAO-B: rs1799836 | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature and pressure pain thresholds | Pain thresholds for warmth and cold measured with the TSA-II, and pressure measured with a digital algometer on the hand and leg. Pain intensity is reported through a numeric rating scale ranging from 0 (no pain) to 10 (worst pain). | At baseline (i.e. before the mental stress test or relaxation breathing), and 20 minutes after the mental stress test and relaxation breathing |
Inclusion Criteria:
Exclusion Criteria:
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Potential study participants will be recruited mainly through online advertisements, but also in hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| Jo Nijs, PhD | Vrije Universiteit Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vrije Universiteit Brussel - UZ Brussel | Brussels | Brussels Capital | 1050 | Belgium |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Whole blood, Peripheral blood mononuclear cells (PBMC), Plasma
| Relaxation breathing | Other | 3 short sessions (4 minutes) of relaxation breathing |
|
| Catecholamine levels |
Levels of adrenaline, noradrenaline and dopamine in plasma |
| 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 | Heart rate variability measured continuously using the Polar H10 | Continuously starting 10 minutes before until 10 minutes after the mental stress test and relaxation breathing |
| Blood pressure | Blood pressure, both systolic and diastolic, measured at specified moments using a digital device | 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 | Activity of the enzymes will be defined in plasma or PBMCs | At baseline (i.e. before the mental stress test or relaxation breathing), and 20 minutes after the mental stress test and relaxation breathing |
| Symptom severity | Symptom severity which is assessed through the Chronic Fatigue Syndrome Symptom List | 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 |
| Level of stress | Numeric rating scale ranging from 0 (no stress) to 10 (worst stress) indicating the 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 |