Clinical trial NCT06892977: Mapping Stress and Pain Interactions (G072323N)
Official title: STRAIN (STRessinpAIN): a Comprehensive Mapping of Stress System Interactions with Pain and Their Contribution to Extent and Chronification of Musculoskeletal Pain
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fibromyalgia
Chronic Low Back Pain
Subacute Low Back Pain
Keywords: Stress system
Musculoskeletal pain
Pain chronification
Pain processing
Neural correlates of pain
Stress reactivity
Stress recovery
Autonomic nervous system (ANS)
Hypothalamus-pituitary-adrenal axis (HPA axis)
Chronic widespread pain
Chronic localized pain
Oxytocin
Low back pain
Fibromyalgia
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
name: Tilburg University
First posted: 2025-03-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population is a community sample.

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.


Eligibility criteria: Inclusion Criteria:

• 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

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.

Primary outcomes:
measure: Quantitative sensory testing - pressure pain threshold
timeFrame: At baseline
measure: Quantitative sensory testing - heat pain suprathreshold
timeFrame: At baseline
measure: Quantitative sensory testing - conditioned pain modulation
timeFrame: At baseline
measure: Quantitative sensory testing - temporal summation of pain
timeFrame: At baseline
measure: Task-based functional MRI - experimental pain induction task
timeFrame: At baseline
measure: Salivary cortisol concentration
timeFrame: At baseline
measure: Salivary alpha-amylase concentration
timeFrame: At baseline
measure: Salivary oxytocin concentration
timeFrame: At baseline
measure: Heart rate
timeFrame: At baseline
measure: Heart rate variability
timeFrame: At baseline
measure: Skin conductance
timeFrame: At baseline
measure: Skin temperature
timeFrame: At baseline
measure: Respiration rate
timeFrame: At baseline
measure: Blood pressure
timeFrame: At baseline
Secondary outcomes:
measure: Visual Analogue Scale - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Pain Disability Index - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Pain Catastrophizing Scale - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Pain Vigilance and Awareness Questionnaire - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: General Perceived Recovery - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Pain Anxiety Symptoms Scale - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Positive and Negative Affect Schedule - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Brief Resilience Scale - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Intolerance of Uncertainty Scale - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Stress Mindset Measure - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Perceived Stress Scale - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Hospital Anxiety and Depression Scale - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Childhood Trauma Questionnaire - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Pittsburgh Sleep Quality Index - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: Gender and Pain Questionnaire - Self-reported
timeFrame: At baseline and at the 6-month follow-up
measure: T1 weighted anatomical MRI data
timeFrame: At baseline and at the 6-month follow-up
measure: Resting state functional MRI
timeFrame: At baseline and at the 6-month follow-up
measure: Diffusion weighted MRI data
timeFrame: At baseline and at the 6-month follow-up
measure: Pseudo-Continuous Arterial Spin Labeling - MRI
timeFrame: At baseline and at the 6-month follow-up
measure: Quantitative sensory testing - pressure pain threshold (at follow-up)
timeFrame: At the 6-month follow-up
measure: Quantitative sensory testing - heat pain suprathreshold (at follow-up)
timeFrame: At the 6-month follow-up
measure: Quantitative sensory testing - conditioned pain modulation (at follow-up)
timeFrame: At the 6-month follow-up
measure: Quantitative sensory testing - temporal summation of pain (at follow-up)
timeFrame: At the 6-month follow-up
measure: Task-based functional MRI - experimental pain induction task (at follow-up)
timeFrame: At the 6-month follow-up
measure: Salivary cortisol concentration (at follow-up)
timeFrame: At the 6-month follow-up
measure: Salivary alpha-amylase concentration (at follow-up)
timeFrame: At the 6-month follow-up
measure: Salivary oxytocin concentration (at follow-up)
timeFrame: At the 6-month follow-up
measure: Heart rate (at follow-up)
timeFrame: At the 6-month follow-up
measure: Heart rate variability (at follow-up)
timeFrame: At the 6-month follow-up
measure: Skin conductance (at follow-up)
timeFrame: At the 6-month follow-up
measure: Skin temperature (at follow-up)
timeFrame: At the 6-month follow-up
measure: Respiration rate (at follow-up)
timeFrame: At the 6-month follow-up
measure: Blood pressure (at follow-up)
timeFrame: At the 6-month follow-up
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University, Department of Rehabilitation Sciences
Study officials:
References: