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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04934917
Acronym
POADOSpre
Enrollment
41
Registered
2021-06-22
Start date
2019-08-28
Completion date
2021-07-01
Last updated
2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease

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).

Interventions

DEVICEMagnetic Resonance Imaging

Magnetic Resonance Imaging. Pain testing: Temporal summation, Pain thresholds. Assessment of symptoms: Questionnaires. All interventions are made at baseline only (1 time/subject).

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Functional magnetic resonance imaging (rsfMRI)BaselineAnalysis of network connectivity during resting state
Functional magnetic resonance imaging (BOLD)Baselinecerebral pain related activation following evoked pressure pain stimuli
Diffuse Tensor ImagingBaselineWhite matter microstructure (e.g. structural connectivity)
Pressure pain thresholdsBaselinePressure allometry (mmHg)
Temporal summationBaselinePain ratings during repeated pressure stimuli, ratings from 0-100, with 100 being worst pain imaginable

Secondary

MeasureTime frameDescription
Pain catastrophizing scaleBaselineTotal score 0-52, high values more catastrophizing
EuroQual-5DBaselineScale ranging from -0.224 to 1, with 1 being highest possible health related quality of life
State-Trait Anxiety InventoryBaselineScores 20-80 for state and 20-80 for trait anxiety, higher levels indicate more anxiety
Beck Depression InventoryBaselineScores 0-63, with 63 highest depression
Pain intensity ratingsBaselineVisual analogue scale, 0-100 mm, 100 mm, worst possible pain
Oswestry Disability IndexBaseline0-100, 0=no disability, 100= worst disability
Fibromyalgia criteria-2016 revision (American College of Rheumatology)BaselineCalculation of FMness score, 0-31, 0 = no symptoms, 31 = worst symptoms
Multidimensional Fatigue InventoryBaselineTotal fatigue score, range 20-100, 100 = worst fatigue

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026