Mapping Stress and Pain Interactions (G072323N)

Официальное название

STRAIN (STRessinpAIN): a Comprehensive Mapping of Stress System Interactions with Pain and Their Contribution to Extent and Chronification of Musculoskeletal Pain

Обзор

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.

Первичные конечные точки

• Quantitative sensory testing - pressure pain threshold [Срок оценки: At baseline]
• Quantitative sensory testing - heat pain suprathreshold [Срок оценки: At baseline]
• Quantitative sensory testing - conditioned pain modulation [Срок оценки: At baseline]
• Quantitative sensory testing - temporal summation of pain [Срок оценки: At baseline]
• Task-based functional MRI - experimental pain induction task [Срок оценки: At baseline]
• Salivary cortisol concentration [Срок оценки: At baseline]
• Salivary alpha-amylase concentration [Срок оценки: At baseline]
• Salivary oxytocin concentration [Срок оценки: At baseline]
• Heart rate [Срок оценки: At baseline]
• Heart rate variability [Срок оценки: At baseline]

Вторичные конечные точки (12)

• Visual Analogue Scale - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• Pain Disability Index - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• Pain Catastrophizing Scale - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• Pain Vigilance and Awareness Questionnaire - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• General Perceived Recovery - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• Pain Anxiety Symptoms Scale - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• Positive and Negative Affect Schedule - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• Brief Resilience Scale - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• Intolerance of Uncertainty Scale - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• Stress Mindset Measure - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• Perceived Stress Scale - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]
• Hospital Anxiety and Depression Scale - Self-reported [Срок оценки: At baseline and at the 6-month follow-up]

Критерии участия

Критерии включения

• Participants aged 18 to 45 years with a BMI between 18.5 and 35 kg/m², who are proficient in the Dutch language and do not meet the exclusion criteria listed below

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Бельгия · 1 центр

• Ghent University, Department of Rehabilitation Sciences — Ghent

Публикации

• 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. PMID 40554512

Идентификаторы

NCT: NCT06892977 · ONZ-2024-0391

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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