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映射应力和疼痛相互作用(G072323N) (STRAIN)

2026年9月16日 更新者:University Ghent

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.

研究概览

地位

邀请报名

研究类型

观察性的

注册 (估计的)

140

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Ghent、比利时、9000
        • Ghent University, Department of Rehabilitation Sciences

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Study population is a community sample.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:OTHER
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Quantitative sensory testing - pressure pain threshold
大体时间:At baseline

Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg.

At baseline
Quantitative sensory testing - heat pain suprathreshold
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:At baseline

Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system.

At baseline
Skin temperature
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Visual Analogue Scale - Self-reported
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月8日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2025年1月31日

首先提交符合 QC 标准的

2025年3月17日

首次发布 (实际的)

2025年3月25日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月16日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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