Chronic Low Back Pain, Fibromyalgia, Subacute Low Back Pain
Conditions
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
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.
Interventions
None listed
Sponsors
Vrije Universiteit Brussel
Tilburg University
University Ghent
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative sensory testing - pressure pain threshold | At baseline | Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg. |
| Quantitative sensory testing - heat pain suprathreshold | At baseline | Determination of the mean of heat pain threshold and heat pain tolerance with TSA-2, recorded in °C. |
| Quantitative sensory testing - conditioned pain modulation | At baseline | 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. |
| Quantitative sensory testing - temporal summation of pain | At baseline | 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. |
| Task-based functional MRI - experimental pain induction task | At baseline | This type of functional MRI-scanning will allow to capture acute brain responses to (painful) heat stimuli and processes of pain modulation. |
| Salivary cortisol concentration | At baseline | 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. |
| Salivary alpha-amylase concentration | At baseline | 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. |
| Salivary oxytocin concentration | At baseline | Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse oxytocin concentrations; providing information about the oxytocinergic system. |
| Heart rate | At baseline | 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. |
| Heart rate variability | At baseline | 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. |
| Skin conductance | At baseline | Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system. |
| Skin temperature | At baseline | Skin temperature, the measurement of the temperature at the skin's surface will be measured continuously; providing information on the autonomic nervous system. |
| Respiration rate | At baseline | Respiration rate, the number of breaths taken per minute will be measured continuously; providing information on the autonomic nervous system. |
| Blood pressure | At baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gender and Pain Questionnaire - Self-reported | At baseline and at the 6-month follow-up | Collection of scales of measures for gender conceptualization, gender identity and gendered pain beliefs |
| T1 weighted anatomical MRI data | At baseline and at the 6-month follow-up | Through Magnetization Prepared-Rapid Gradient Echo, macro-structural properties of grey matter, such as surface area, cortical thickness or volume will be characterized. |
| Resting state functional MRI | At baseline and at the 6-month follow-up | This type of MRI-scan will allow us to evaluate functional connectivity of the brain. |
| Diffusion weighted MRI data | At baseline and at the 6-month follow-up | Diffusion weighted MR imaging will provide insights in microstructural properties of white matter (i.e., factional anisotropy, mean diffusivity, etc.). |
| Pseudo-Continuous Arterial Spin Labeling - MRI | At baseline and at the 6-month follow-up | This type of MRI will provide information on brain blood perfusion parameters. |
| Quantitative sensory testing - pressure pain threshold (at follow-up) | At the 6-month follow-up | Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg. |
| Quantitative sensory testing - heat pain suprathreshold (at follow-up) | At the 6-month follow-up | Determination of the mean of heat pain threshold and heat pain tolerance with TSA-2, recorded in °C. |
| Quantitative sensory testing - conditioned pain modulation (at follow-up) | At the 6-month 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. |
| Quantitative sensory testing - temporal summation of pain (at follow-up) | At the 6-month 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. |
| Task-based functional MRI - experimental pain induction task (at follow-up) | At the 6-month follow-up | This type of functional MRI-scanning will allow to capture acute brain responses to (painful) heat stimuli and processes of pain modulation. |
| Salivary cortisol concentration (at follow-up) | At the 6-month 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. |
| Salivary alpha-amylase concentration (at follow-up) | At the 6-month 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. |
| Salivary oxytocin concentration (at follow-up) | At the 6-month 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. |
| Heart rate (at follow-up) | At the 6-month 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. |
| Visual Analogue Scale - Self-reported | At baseline and at the 6-month follow-up | Assessment of momentary pain, unpleasantness and stress on a VAS scale ranging from 0-100 |
| Skin conductance (at follow-up) | At the 6-month follow-up | Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system. |
| Skin temperature (at follow-up) | At the 6-month 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. |
| Respiration rate (at follow-up) | At the 6-month follow-up | Respiration rate, the number of breaths taken per minute will be measured continuously; providing information on the autonomic nervous system. |
| Blood pressure (at follow-up) | At the 6-month 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. |
| Heart rate variability (at follow-up) | At the 6-month 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. |
| Pain Disability Index - Self-reported | At baseline and at the 6-month follow-up | Assessment of pain-related interference in daily activities, recorded on a 0-70 scale |
| Pain Catastrophizing Scale - Self-reported | At baseline and at the 6-month follow-up | Measurement of catastrophic thinking related to pain, recorded on a scale of 0-52. |
| Pain Vigilance and Awareness Questionnaire - Self-reported | At baseline and at the 6-month follow-up | Assessment of attention and awareness to pain, recorded on a 0-80 scale. |
| General Perceived Recovery - Self-reported | At baseline and at the 6-month follow-up | 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 |
| Pain Anxiety Symptoms Scale - Self-reported | At baseline and at the 6-month follow-up | Assessment of fear and anxiety associated with pain, recorded on a 0-100 scale. |
| Positive and Negative Affect Schedule - Self-reported | At baseline and at the 6-month follow-up | Measurement of positive and negative affect levels. Total scores for positive and negative affect range for 10-50 separately. |
| Brief Resilience Scale - Self-reported | At baseline and at the 6-month follow-up | Measurement of the ability to recover from stress, recorded on a 5-point Likert scale. This questionnaire contains 6 items. |
| Intolerance of Uncertainty Scale - Self-reported | At baseline and at the 6-month follow-up | Assessment of intolerance to uncertainty, recorded on a scale of 1-5 for each item, with 12 items in total. |
| Stress Mindset Measure - Self-reported | At baseline and at the 6-month follow-up | 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. |
| Perceived Stress Scale - Self-reported | At baseline and at the 6-month follow-up | Measurement of perceived stress over the past month, recorded on a scale of 0-40. |
| Hospital Anxiety and Depression Scale - Self-reported | At baseline and at the 6-month follow-up | Assessment of anxiety and depression symptoms, recorded on a scale of 0-21 for anxiety and depression subscales separately. |
| Childhood Trauma Questionnaire - Self-reported | At baseline and at the 6-month follow-up | 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. |
| Pittsburgh Sleep Quality Index - Self-reported | At baseline and at the 6-month follow-up | 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. |
Countries
Belgium
Outcome results
None listed