Brain Imaging of Pain-Related Processing and Structural Properties in Disc Degenerative Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Functional magnetic resonance imaging (rsfMRI)
研究概览
简要总结
In this study, we apply brain MR imaging techniques at 3 Tesla to assess pain-relevant processing in patients with disc degenerative disease (DDD) scheduled for back surgery and age- and gender-matched controls without back pain. Data collection pre-surgery is performed over two days: On the first day, all participants undergo a battery of questionnaires relevant for individuals with chronic pain and pain sensitivity testing, including temporal summation and pressure pain thresholds. On the second day, participants undergo a MRI protocol, which includes functional MRI (fMRI) and diffusion tensor imaging to assess microstructural properties and structural connectivity. During fMRI, an experimental pressure pain paradigm is performed at the calf i.e. a location not connected to patients' chronic pain condition. Instead, the experimental pain paradigm serves as a condition to test processing of noxious stimulation unrelated to patients' experienced chronic pain. The noxious input pressure is individually calibrated to 50 on a 0-100 VAS scale to ensure that individual pain perceptions, despite different pressure intensities, are comparable across participants. The sensory stimulation will consist of a low standardized pressure intensity (150kPa). In an additional fMRI paradigm, participants do not receive stimulation but are instructed to continuously rate fluctuating spontaneous ongoing back pain (DDD) or perceived unpleasantness (controls).
This project aims at investigating measures of brain architecture, neural response connected with evoked pain, connectivity (structural and functional) and pain-relevant psychometrics and questionnaire data in disc degenerative disease patients scheduled for back surgery. Specifically, MRI is performed to test whether i) patients display differences in properties of the mesolimbic circuit compared to healthy individuals and ii) behavioural as well as clinical characteristics related to the acquired MRI markers. This study is intended to serve as a baseline in a longitudinal project testing associations with between findings at baseline and following surgery (fusion/disc implants).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •30-60 year
- •Right-handed
- •DDD patients: Radiologically verified DDD and DDD pain as their main pain complaint
排除标准
- •previous spine surgery
- •significant pain problems due to other causes and/or other chronic pain syndromes
- •inflammatory rheumatic diseases
- •neurological/psychiatric disorders
- •severe cardiovascular disease
- •substance abuse
- •Contraindication to MRI
结局指标
主要结局
Functional magnetic resonance imaging (rsfMRI)
时间窗: Baseline
Analysis of network connectivity during resting state
Functional magnetic resonance imaging (BOLD)
时间窗: Baseline
cerebral pain related activation following evoked pressure pain stimuli
Diffuse Tensor Imaging
时间窗: Baseline
White matter microstructure (e.g. structural connectivity)
Pressure pain thresholds
时间窗: Baseline
Pressure allometry (mmHg)
Temporal summation
时间窗: Baseline
Pain ratings during repeated pressure stimuli, ratings from 0-100, with 100 being worst pain imaginable
次要结局
- Beck Depression Inventory(Baseline)
- Oswestry Disability Index(Baseline)
- Multidimensional Fatigue Inventory(Baseline)
- Pain intensity ratings(Baseline)
- EuroQual-5D(Baseline)
- Fibromyalgia criteria-2016 revision (American College of Rheumatology)(Baseline)
- Pain catastrophizing scale(Baseline)
- State-Trait Anxiety Inventory(Baseline)
研究者
Eva Kosek
Principal Investigator, Professor, MD
Karolinska Institutet
