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- Ensaio Clínico NCT06892977
Interações com estresse e dor de mapeamento (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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Ghent, Bélgica, 9000
- Ghent University, Department of Rehabilitation Sciences
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Study population is a community sample.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: OTHER
- Perspectivas de Tempo: CROSS_SECTIONAL
Coortes e Intervenções
Grupo / Coorte |
|---|
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quantitative sensory testing - pressure pain threshold
Prazo: At baseline
|
Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg. |
At baseline
|
|
Quantitative sensory testing - heat pain suprathreshold
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: At baseline
|
Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system. |
At baseline
|
|
Skin temperature
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Visual Analogue Scale - Self-reported
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Dor lombar
- Ocitocina
- Fibromialgia
- Dor crônica generalizada
- Dor musculoesquelética
- Processamento da dor
- Reatividade ao estresse
- Sistema nervoso autônomo (SNA)
- Sistema de estresse
- Cronificação da dor
- Correlatos neurais da dor
- Recuperação de estresse
- Eixo Hipotálamo-Pituitário-Adrenal (eixo HPA)
- Dor localizada crônica
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ONZ-2024-0391
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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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