Mapping Stress and Pain Interactions (G072323N)

NCT ID: NCT06892977

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-08
• Study Completion Date: 2026-12-31

Brief Summary

The over-arching goal of this observational (case-control, with a cross-sectional and longitudinal arm) study is to comprehensively map stress system (dys)function (including reactivity and recovery) in people with primary musculoskeletal (MSK) pain and a pain-free control group.

• The primary objective is to characterize stress systems functioning and their relation to pain in individuals with subacute versus chronic, and localized versus widespread MSK pain, and compare to pain-free controls.
• The secondary objective is to define the contribution of stress system functioning to trajectories of MSK pain, including pain chronification or recovery from pain.

Researchers will compare primary musculoskeletal pain groups with pain-free controls. Participants will:

• Fill out online questionnaires.
• Provide a sample of hair and saliva to assess chronic and acute stress hormone levels, respectively. Saliva samples will be collected both in the lab and at home.
• Be subject to psychophysiological monitoring.
• Partake in quantitative sensory testing measuring pain thresholds, tolerances and pain modulation of pressure and heat. These tests will be repeated twice: before and after an acute-stress induction task.
• Partake in a series of stress-inducting tasks.
• Be subject to MRI-scans of the brain, including structural and functional MR acquisitions (e.g., during rest and during pain inductions).

Participants will be invited for a second session of the same assessments six months later to observe possible connection between pain trajectory and stress system (dys)function.

Conditions

Fibromyalgia; Chronic Low Back Pain; Subacute Low Back Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

fibromyalgia

Proof of a primary fibromyalgia diagnosis with chronic widespread pain by a specialist-doctor, with an average pain intensity of ≥2/10 on a Visual Analogue Scale, and with pain-related disability indicated by a score of ≥14/70 on the Pain Disability Index.

No interventions assigned to this group

chronic low back pain

Chronic primary (non-specific) low back pain with primary onset ≥6 months ago, with an average pain intensity of ≥2/10 on a Visual Analogue Scale, and with pain-related disability indicated by a score of ≥14/70 on the Pain Disability Index.

No interventions assigned to this group

subacute low back pain

Non-specific low back pain with primary onset \<3 months ago, with an average pain intensity of ≥2/10 on a Visual Analogue Scale, and with pain-related disability indicated by a score of ≥14/70 on the Pain Disability Index.

No interventions assigned to this group

pain-free/healthy control

Exclusion criteria include current pain (\>0 on a Visual Analogue Scale); a pain condition in the last 6 months for which treatment was sought; history of a chronic pain syndrome.

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

• Body weight >150 kg (maximum weight for the MRI scanner).
• Postmenopausal individuals.
• Use of hormone replacement therapy.
• Current or history of severe psychiatric, neurological (related to the brain, spinal cord, or nerves), endocrine (related to the hormonal system), or cardiovascular (related to the heart and blood vessels) conditions (e.g., cancer, cardiovascular disease, epilepsy, diabetes, etc.).
• History of spinal surgery, spinal trauma, severe spinal deformities, or neurogenic back pain.
• Having a severe communicative or cognitive disorder.
• Use of medication that is not stable for at least 1 month prior to the test session.
• Regular drug use (≥1 time per week).
• Contraindications for MRI (such as claustrophobia, implanted electronic devices like a pacemaker, metal splinters in the body, etc.).
• Currently pregnant or have been pregnant in the past year.
• Breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

Tilburg University

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ghent University, Department of Rehabilitation Sciences

Ghent, , Belgium

Countries

Belgium

References

Moerkerke M, Vyverman J, De Baere R, Clement P, Smeets T, Coppieters I, Timmers I, Van Oosterwijck J. A comprehensive mapping of stress system interactions with pain and their contribution to chronification of musculoskeletal pain: Protocol of the STRAIN study. PLoS One. 2025 Jun 24;20(6):e0324089. doi: 10.1371/journal.pone.0324089. eCollection 2025.

Reference Type: DERIVED

PMID: 40554512 (View on PubMed)

Other Identifiers

ONZ-2024-0391

Identifier Type: -

Identifier Source: org_study_id