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临床试验/NCT04934917
NCT04934917终止不适用

Brain Imaging of Pain-Related Processing and Structural Properties in Disc Degenerative Disease

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年8月28日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Kosek

Principal Investigator, Professor, MD

Karolinska Institutet

研究点 (2)

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