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Mapping Stress and Pain Interactions (G072323N)

Study acronym: STRAIN
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2026 → Dec 2026
See other at-risk trials from University Ghent

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Jun 2026 to Dec 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 8 of 33 entries
    • Publications: details revised at 1 of 1 entry
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06892977
Lead Sponsor University Ghent
Collaborators: Vrije Universiteit Brussel, Tilburg University
Conditions
(from sponsor)
Fibromyalgia, Chronic Low Back Pain, Subacute Low Back Pain
Related terms Chronic Pain, Fibromyalgia, Low Back Pain, Musculoskeletal Pain
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov