Clinical trial NCT04934917: Brain Imaging of Pain-Related Processing and Structural Properties in Disc Degenerative Disease
Official title: Brain Imaging of Pain-Related Processing and Structural Properties in Disc Degenerative Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Disc Disease
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 41
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited through clinical collaborators (Stockholm Spine Center, Rygg Kirurgisk Centrum); HC will be recruited via online advertisement on the institution's website

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:Inclusion criteria:

* 30-60 year
* Right-handed
* DDD patients: Radiologically verified DDD and DDD pain as their main pain complaint

Exclusion Criteria:

* 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
* BMI\>40
* Contraindication to MRI

Primary outcomes:
measure: Functional magnetic resonance imaging (rsfMRI)
timeFrame: Baseline
measure: Functional magnetic resonance imaging (BOLD)
timeFrame: Baseline
measure: Diffuse Tensor Imaging
timeFrame: Baseline
measure: Pressure pain thresholds
timeFrame: Baseline
measure: Temporal summation
timeFrame: Baseline
Secondary outcomes:
measure: Pain intensity ratings
timeFrame: Baseline
measure: Oswestry Disability Index
timeFrame: Baseline
measure: Fibromyalgia criteria-2016 revision (American College of Rheumatology)
timeFrame: Baseline
measure: Multidimensional Fatigue Inventory
timeFrame: Baseline
measure: Pain catastrophizing scale
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: Baseline
measure: State-Trait Anxiety Inventory
timeFrame: Baseline
measure: EuroQual-5D
timeFrame: Baseline
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institute
city: Stockholm
country: Sweden
facility: Karolinska Insitutet
Study officials:
affiliation: Karolinska Institutet
name: Eva Kosek, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: