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| Name | Class |
|---|---|
| Vrije Universiteit Brussel | OTHER |
| Tilburg University | OTHER |
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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.
Researchers will compare primary musculoskeletal pain groups with pain-free controls. Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. | ||
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quantitative sensory testing - pressure pain threshold | Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg. | At baseline |
| Quantitative sensory testing - heat pain suprathreshold | Determination of the mean of heat pain threshold and heat pain tolerance with TSA-2, recorded in °C. | At baseline |
| Quantitative sensory testing - conditioned pain modulation | Determination of conditioned pain modulation with a parallel protocol, with test stimulus and conditioning stimulus equal to the heat pain suprathreshold temperature. Pain will be scored on a verbal rating scale 0-100. | At baseline |
| Quantitative sensory testing - temporal summation of pain | Determination of temporal summation of pain with a tonic protocol. Heat stimuli will be applied for two minutes, with the temperature equal to the heat pain suprathreshold. Pain will be scored on a verbal rating scale 0-100. | At baseline |
| Task-based functional MRI - experimental pain induction task | This type of functional MRI-scanning will allow to capture acute brain responses to (painful) heat stimuli and processes of pain modulation. | At baseline |
| Salivary cortisol concentration | Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse cortisol concentration; providing information about the hypothalamus-pituitary-adrenal-axis functioning. | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale - Self-reported | Assessment of momentary pain, unpleasantness and stress on a VAS scale ranging from 0-100 | At baseline and at the 6-month follow-up |
| Pain Disability Index - Self-reported |
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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:
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Study population is a community sample.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University, Department of Rehabilitation Sciences | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40554512 | Derived | 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. |
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Ghent University will be the data controller. The collected data can only be shared upon request and after finalization of the predetermined statistical analyses and publication of the results. Identifiable data will not be shared. Data sharing is only permitted if all involved parties agree, and if a Data Sharing Agreement is signed.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059352 | Musculoskeletal Pain |
| D059350 | Chronic Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Saliva to examine current alpha-amylase, cortisol and oxytocin levels. Hair to examine cortisol levels over the last 3 months.
| Salivary alpha-amylase concentration | Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse alpha-amylase concentrations; which gives information about the autonomic nervous system functioning. | At baseline |
| Salivary oxytocin concentration | Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse oxytocin concentrations; providing information about the oxytocinergic system. | At baseline |
| Heart rate | Heart rate, the number of times the heart beat within a certain period, will be measured continuously using ECG (electrocardiogram), providing information on the autonomic nervous system. | At baseline |
| Heart rate variability | Heart rate variability (HRV), the fluctuations in time between heart beats, will be measured continuously using ECG. Both time domain and frequency domain of HRV will be examined; providing information on the autonomic nervous system. | At baseline |
| Skin conductance | Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system. | At baseline |
| Skin temperature | Skin temperature, the measurement of the temperature at the skin's surface will be measured continuously; providing information on the autonomic nervous system. | At baseline |
| Respiration rate | Respiration rate, the number of breaths taken per minute will be measured continuously; providing information on the autonomic nervous system. | At baseline |
| Blood pressure | Blood pressure, the force exerted by circulating blood on the walls of blood vessels, will be measured using non-continuously; providing information on the autonomic nervous system. | At baseline |
Assessment of pain-related interference in daily activities, recorded on a 0-70 scale
| At baseline and at the 6-month follow-up |
| Pain Catastrophizing Scale - Self-reported | Measurement of catastrophic thinking related to pain, recorded on a scale of 0-52. | At baseline and at the 6-month follow-up |
| Pain Vigilance and Awareness Questionnaire - Self-reported | Assessment of attention and awareness to pain, recorded on a 0-80 scale. | At baseline and at the 6-month follow-up |
| General Perceived Recovery - Self-reported | 11-point scale to rate perceived recovery from - 5 (vastly worse), through 0 (no change) to + 5 (greatly improved), to assess recovery or persistence of low back pain | At baseline and at the 6-month follow-up |
| Pain Anxiety Symptoms Scale - Self-reported | Assessment of fear and anxiety associated with pain, recorded on a 0-100 scale. | At baseline and at the 6-month follow-up |
| Positive and Negative Affect Schedule - Self-reported | Measurement of positive and negative affect levels. Total scores for positive and negative affect range for 10-50 separately. | At baseline and at the 6-month follow-up |
| Brief Resilience Scale - Self-reported | Measurement of the ability to recover from stress, recorded on a 5-point Likert scale. This questionnaire contains 6 items. | At baseline and at the 6-month follow-up |
| Intolerance of Uncertainty Scale - Self-reported | Assessment of intolerance to uncertainty, recorded on a scale of 1-5 for each item, with 12 items in total. | At baseline and at the 6-month follow-up |
| Stress Mindset Measure - Self-reported | Evaluation of beliefs about the nature of stress (enhancing vs. debilitating), recorded on a scale of 0-4 for each item, with 8 items in total. | At baseline and at the 6-month follow-up |
| Perceived Stress Scale - Self-reported | Measurement of perceived stress over the past month, recorded on a scale of 0-40. | At baseline and at the 6-month follow-up |
| Hospital Anxiety and Depression Scale - Self-reported | Assessment of anxiety and depression symptoms, recorded on a scale of 0-21 for anxiety and depression subscales separately. | At baseline and at the 6-month follow-up |
| Childhood Trauma Questionnaire - Self-reported | Measurement of childhood trauma experiences. A shortened version will be used with scores ranging from 0-25. Emotional abuse, physical abuse, and neglect components will be assessed. | At baseline and at the 6-month follow-up |
| Pittsburgh Sleep Quality Index - Self-reported | Measurement of sleep quality over the past month. A shortened version will be used with scores ranging from 0-12. Component 1-4 will be scored. | At baseline and at the 6-month follow-up |
| Gender and Pain Questionnaire - Self-reported | Collection of scales of measures for gender conceptualization, gender identity and gendered pain beliefs | At baseline and at the 6-month follow-up |
| T1 weighted anatomical MRI data | Through Magnetization Prepared-Rapid Gradient Echo, macro-structural properties of grey matter, such as surface area, cortical thickness or volume will be characterized. | At baseline and at the 6-month follow-up |
| Resting state functional MRI | This type of MRI-scan will allow us to evaluate functional connectivity of the brain. | At baseline and at the 6-month follow-up |
| Diffusion weighted MRI data | Diffusion weighted MR imaging will provide insights in microstructural properties of white matter (i.e., factional anisotropy, mean diffusivity, etc.). | At baseline and at the 6-month follow-up |
| Pseudo-Continuous Arterial Spin Labeling - MRI | This type of MRI will provide information on brain blood perfusion parameters. | At baseline and at the 6-month follow-up |
| Quantitative sensory testing - pressure pain threshold (at follow-up) | Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg. | At the 6-month follow-up |
| Quantitative sensory testing - heat pain suprathreshold (at follow-up) | Determination of the mean of heat pain threshold and heat pain tolerance with TSA-2, recorded in °C. | At the 6-month follow-up |
| Quantitative sensory testing - conditioned pain modulation (at follow-up) | Determination of conditioned pain modulation with a parallel protocol, with test stimulus and conditioning stimulus equal to the heat pain suprathreshold temperature. Pain will be scored on a verbal rating scale 0-100. | At the 6-month follow-up |
| Quantitative sensory testing - temporal summation of pain (at follow-up) | Determination of temporal summation of pain with a tonic protocol. Heat stimuli will be applied for two minutes, with the temperature equal to the heat pain suprathreshold. Pain will be scored on a verbal rating scale 0-100. | At the 6-month follow-up |
| Task-based functional MRI - experimental pain induction task (at follow-up) | This type of functional MRI-scanning will allow to capture acute brain responses to (painful) heat stimuli and processes of pain modulation. | At the 6-month follow-up |
| Salivary cortisol concentration (at follow-up) | Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse cortisol concentrations; providing information about the hypothalamus-pituitary-adrenal-axis functioning. | At the 6-month follow-up |
| Salivary alpha-amylase concentration (at follow-up) | Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse alpha-amylase concentrations; providing information about the autonomic nervous system functioning. | At the 6-month follow-up |
| Salivary oxytocin concentration (at follow-up) | Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse oxytocin concentrations; providing information on the oxytocinergic system. | At the 6-month follow-up |
| Heart rate (at follow-up) | Heart rate, the number of times the heart beat within a certain period, will be measured with ECG continuously, and is part of the autonomic nervous system. | At the 6-month follow-up |
| Heart rate variability (at follow-up) | Heart rate variability, the fluctuations in time between heart beats, will be measured with ECG continuously. Both time domains and frequency domains of HRV will be examined. This parameter is part of the autonomic nervous system. | At the 6-month follow-up |
| Skin conductance (at follow-up) | Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system. | At the 6-month follow-up |
| Skin temperature (at follow-up) | Skin temperature, the measurement of the temperature at the skin's surface will be measured continuously; providing information on the autonomic nervous system. | At the 6-month follow-up |
| Respiration rate (at follow-up) | Respiration rate, the number of breaths taken per minute will be measured continuously; providing information on the autonomic nervous system. | At the 6-month follow-up |
| Blood pressure (at follow-up) | Blood pressure, the force exerted by circulating blood on the walls of blood vessels, will be measured using non-continuously; providing information on the autonomic nervous system. | At the 6-month follow-up |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |