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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-19

Study Completion Date

2025-04-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Widespread Pain

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with chronic widespread pain

Women who received the diagnosis of fibromyalgia from a doctor.

Montreal Imaging Stress Test

Intervention Type OTHER

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

Relaxation breathing

Intervention Type OTHER

3 short sessions (4 minutes) of relaxation breathing

Healthy women

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

Montreal Imaging Stress Test

Intervention Type OTHER

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

Relaxation breathing

Intervention Type OTHER

3 short sessions (4 minutes) of relaxation breathing

Interventions

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Montreal Imaging Stress Test

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

Intervention Type OTHER

Relaxation breathing

3 short sessions (4 minutes) of relaxation breathing

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes