STRAIN (STRessinpAIN): A Comprehensive Mapping of Stress System Interactions With Pain and Their Contribution to Extent and Chronification of Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Quantitative sensory testing - pressure pain threshold
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
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.
结局指标
主要结局
Quantitative sensory testing - pressure pain threshold
时间窗: At baseline
Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg.
Quantitative sensory testing - heat pain suprathreshold
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: At baseline
Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system.
Skin temperature
时间窗: 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
时间窗: At baseline
Respiration rate, the number of breaths taken per minute will be measured continuously; providing information on the autonomic nervous system.
Blood pressure
时间窗: 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.
次要结局
- Visual Analogue Scale - Self-reported(At baseline and at the 6-month follow-up)
- Pain Disability Index - Self-reported(At baseline and at the 6-month follow-up)
- Pain Catastrophizing Scale - Self-reported(At baseline and at the 6-month follow-up)
- Pain Vigilance and Awareness Questionnaire - Self-reported(At baseline and at the 6-month follow-up)
- General Perceived Recovery - Self-reported(At baseline and at the 6-month follow-up)
- Pain Anxiety Symptoms Scale - Self-reported(At baseline and at the 6-month follow-up)
- Positive and Negative Affect Schedule - Self-reported(At baseline and at the 6-month follow-up)
- Brief Resilience Scale - Self-reported(At baseline and at the 6-month follow-up)
- Intolerance of Uncertainty Scale - Self-reported(At baseline and at the 6-month follow-up)
- Stress Mindset Measure - Self-reported(At baseline and at the 6-month follow-up)
- Perceived Stress Scale - Self-reported(At baseline and at the 6-month follow-up)
- Hospital Anxiety and Depression Scale - Self-reported(At baseline and at the 6-month follow-up)
- Childhood Trauma Questionnaire - Self-reported(At baseline and at the 6-month follow-up)
- Pittsburgh Sleep Quality Index - Self-reported(At baseline and at the 6-month follow-up)
- Gender and Pain Questionnaire - Self-reported(At baseline and at the 6-month follow-up)
- T1 weighted anatomical MRI data(At baseline and at the 6-month follow-up)
- Resting state functional MRI(At baseline and at the 6-month follow-up)
- Diffusion weighted MRI data(At baseline and at the 6-month follow-up)
- Pseudo-Continuous Arterial Spin Labeling - MRI(At baseline and at the 6-month follow-up)
- Quantitative sensory testing - pressure pain threshold (at follow-up)(At the 6-month follow-up)
- Quantitative sensory testing - heat pain suprathreshold (at follow-up)(At the 6-month follow-up)
- Quantitative sensory testing - conditioned pain modulation (at follow-up)(At the 6-month follow-up)
- Quantitative sensory testing - temporal summation of pain (at follow-up)(At the 6-month follow-up)
- Task-based functional MRI - experimental pain induction task (at follow-up)(At the 6-month follow-up)
- Salivary cortisol concentration (at follow-up)(At the 6-month follow-up)
- Salivary alpha-amylase concentration (at follow-up)(At the 6-month follow-up)
- Salivary oxytocin concentration (at follow-up)(At the 6-month follow-up)
- Heart rate (at follow-up)(At the 6-month follow-up)
- Heart rate variability (at follow-up)(At the 6-month follow-up)
- Skin conductance (at follow-up)(At the 6-month follow-up)
- Skin temperature (at follow-up)(At the 6-month follow-up)
- Respiration rate (at follow-up)(At the 6-month follow-up)
- Blood pressure (at follow-up)(At the 6-month follow-up)