- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT06892977
Kartoitus stressi- ja kivun vuorovaikutukset (G072323N) (STRAIN)
STRAIN (STRessinpAIN): A Comprehensive Mapping of Stress System Interactions With Pain and Their Contribution to Extent and Chronification of Musculoskeletal Pain
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.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
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Ghent, Belgia, 9000
- Ghent University, Department of Rehabilitation Sciences
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Study population is a community sample.
Kuvaus
Inclusion Criteria:
• Participants aged 18 to 55 years with a BMI between 17 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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: OTHER
- Aikanäkymät: CROSS_SECTIONAL
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
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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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Quantitative sensory testing - pressure pain threshold
Aikaikkuna: At baseline
|
Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg. |
At baseline
|
|
Quantitative sensory testing - heat pain suprathreshold
Aikaikkuna: At baseline
|
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
Aikaikkuna: 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. |
At baseline
|
|
Quantitative sensory testing - temporal summation of pain
Aikaikkuna: 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. |
At baseline
|
|
Task-based functional MRI - experimental pain induction task
Aikaikkuna: At baseline
|
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
Aikaikkuna: 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. |
At baseline
|
|
Salivary alpha-amylase concentration
Aikaikkuna: 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. |
At baseline
|
|
Salivary oxytocin concentration
Aikaikkuna: 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. |
At baseline
|
|
Heart rate
Aikaikkuna: 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. |
At baseline
|
|
Heart rate variability
Aikaikkuna: 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. |
At baseline
|
|
Skin conductance
Aikaikkuna: At baseline
|
Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system. |
At baseline
|
|
Skin temperature
Aikaikkuna: 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. |
At baseline
|
|
Respiration rate
Aikaikkuna: At baseline
|
Respiration rate, the number of breaths taken per minute will be measured continuously; providing information on the autonomic nervous system. |
At baseline
|
|
Blood pressure
Aikaikkuna: 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. |
At baseline
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Visual Analogue Scale - Self-reported
Aikaikkuna: At baseline and at the 6-month follow-up
|
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
Aikaikkuna: At baseline and at the 6-month follow-up
|
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
Aikaikkuna: At baseline and at the 6-month follow-up
|
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
Aikaikkuna: At baseline and at the 6-month follow-up
|
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
Aikaikkuna: 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 |
At baseline and at the 6-month follow-up
|
|
Pain Anxiety Symptoms Scale - Self-reported
Aikaikkuna: At baseline and at the 6-month follow-up
|
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
Aikaikkuna: 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. |
At baseline and at the 6-month follow-up
|
|
Brief Resilience Scale - Self-reported
Aikaikkuna: 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. |
At baseline and at the 6-month follow-up
|
|
Intolerance of Uncertainty Scale - Self-reported
Aikaikkuna: 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. |
At baseline and at the 6-month follow-up
|
|
Stress Mindset Measure - Self-reported
Aikaikkuna: 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. |
At baseline and at the 6-month follow-up
|
|
Perceived Stress Scale - Self-reported
Aikaikkuna: At baseline and at the 6-month follow-up
|
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
Aikaikkuna: 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. |
At baseline and at the 6-month follow-up
|
|
Childhood Trauma Questionnaire - Self-reported
Aikaikkuna: 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. |
At baseline and at the 6-month follow-up
|
|
Pittsburgh Sleep Quality Index - Self-reported
Aikaikkuna: 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. |
At baseline and at the 6-month follow-up
|
|
Gender and Pain Questionnaire - Self-reported
Aikaikkuna: At baseline and at the 6-month follow-up
|
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
Aikaikkuna: 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. |
At baseline and at the 6-month follow-up
|
|
Resting state functional MRI
Aikaikkuna: At baseline and at the 6-month follow-up
|
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
Aikaikkuna: 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.). |
At baseline and at the 6-month follow-up
|
|
Pseudo-Continuous Arterial Spin Labeling - MRI
Aikaikkuna: At baseline and at the 6-month follow-up
|
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)
Aikaikkuna: At the 6-month 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)
Aikaikkuna: At the 6-month 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)
Aikaikkuna: 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. |
At the 6-month follow-up
|
|
Quantitative sensory testing - temporal summation of pain (at follow-up)
Aikaikkuna: 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. |
At the 6-month follow-up
|
|
Task-based functional MRI - experimental pain induction task (at follow-up)
Aikaikkuna: 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. |
At the 6-month follow-up
|
|
Salivary cortisol concentration (at follow-up)
Aikaikkuna: 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. |
At the 6-month follow-up
|
|
Salivary alpha-amylase concentration (at follow-up)
Aikaikkuna: 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. |
At the 6-month follow-up
|
|
Salivary oxytocin concentration (at follow-up)
Aikaikkuna: 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. |
At the 6-month follow-up
|
|
Heart rate (at follow-up)
Aikaikkuna: 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. |
At the 6-month follow-up
|
|
Heart rate variability (at follow-up)
Aikaikkuna: 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. |
At the 6-month follow-up
|
|
Skin conductance (at follow-up)
Aikaikkuna: At the 6-month 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)
Aikaikkuna: 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. |
At the 6-month follow-up
|
|
Respiration rate (at follow-up)
Aikaikkuna: 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. |
At the 6-month follow-up
|
|
Blood pressure (at follow-up)
Aikaikkuna: 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. |
At the 6-month follow-up
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
- Alaselän kipu
- Oksitosiini
- Fibromyalgia
- Krooninen laajalle levinnyt kipu
- Tuki- ja liikuntaelimistön kipu
- Kivun käsittely
- Stressireaktiivisuus
- Autonominen hermosto (ANS)
- Stressijärjestelmä
- Kipu
- Kivun hermokorrelaatit
- Stressin palautuminen
- Hypotalamus-aivolisäkkeen ja lisämunuaisen akseli (HPA-akseli)
- Krooninen paikallinen kipu
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- ONZ-2024-0391
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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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