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

Terminated

• Conditions: Degenerative Disc Disease
• Interventions: Device: Magnetic Resonance Imaging

• Registration Number: NCT04934917
• Lead Sponsor: Karolinska Institutet

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-28
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Inclusion criteria:

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with disc degenerative disease (DDD)	Magnetic Resonance Imaging	Patients suffering from disc degenerative disease, age 30-60 years that are on the waiting list for surgery (fusion/disc implants) at Stockholm Spine Center, Stockholm, Sweden.
Healthy controls (HC)	Magnetic Resonance Imaging	Healthy controls matched according to age and sex, no chronic pain conditions.

Primary Outcome Measures

Name	Time	Method
Functional magnetic resonance imaging (BOLD)	Baseline	cerebral pain related activation following evoked pressure pain stimuli
Diffuse Tensor Imaging	Baseline	White matter microstructure (e.g. structural connectivity)
Pressure pain thresholds	Baseline	Pressure allometry (mmHg)
Temporal summation	Baseline	Pain ratings during repeated pressure stimuli, ratings from 0-100, with 100 being worst pain imaginable
Functional magnetic resonance imaging (rsfMRI)	Baseline	Analysis of network connectivity during resting state

Secondary Outcome Measures

Name	Time	Method
Pain intensity ratings	Baseline	Visual analogue scale, 0-100 mm, 100 mm, worst possible pain
Oswestry Disability Index	Baseline	0-100, 0=no disability, 100= worst disability
Multidimensional Fatigue Inventory	Baseline	Total fatigue score, range 20-100, 100 = worst fatigue
Fibromyalgia criteria-2016 revision (American College of Rheumatology)	Baseline	Calculation of FMness score, 0-31, 0 = no symptoms, 31 = worst symptoms
Pain catastrophizing scale	Baseline	Total score 0-52, high values more catastrophizing
State-Trait Anxiety Inventory	Baseline	Scores 20-80 for state and 20-80 for trait anxiety, higher levels indicate more anxiety
EuroQual-5D	Baseline	Scale ranging from -0.224 to 1, with 1 being highest possible health related quality of life
Beck Depression Inventory	Baseline	Scores 0-63, with 63 highest depression

Trial Locations

Locations (2)

Karolinska Institute; 🇸🇪 Stockholm, Sweden

Karolinska Insitutet; 🇸🇪 Stockholm, Sweden