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

Degenerative Disc Disease Clinical Trial

— POADOSpre  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04934917
• Other study ID #: 2019-01142_1pre
• Status: Terminated
• Start date: August 28, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• Magnetic 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).

Locations

Country	Name	City	State
Sweden	Karolinska Insitutet	Stockholm
Sweden	Karolinska Institute	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional magnetic resonance imaging (rsfMRI)	Analysis of network connectivity during resting state	Baseline
Primary	Functional magnetic resonance imaging (BOLD)	cerebral pain related activation following evoked pressure pain stimuli	Baseline
Primary	Diffuse Tensor Imaging	White matter microstructure (e.g. structural connectivity)	Baseline
Primary	Pressure pain thresholds	Pressure allometry (mmHg)	Baseline
Primary	Temporal summation	Pain ratings during repeated pressure stimuli, ratings from 0-100, with 100 being worst pain imaginable	Baseline
Secondary	Pain intensity ratings	Visual analogue scale, 0-100 mm, 100 mm, worst possible pain	Baseline
Secondary	Oswestry Disability Index	0-100, 0=no disability, 100= worst disability	Baseline
Secondary	Fibromyalgia criteria-2016 revision (American College of Rheumatology)	Calculation of FMness score, 0-31, 0 = no symptoms, 31 = worst symptoms	Baseline
Secondary	Multidimensional Fatigue Inventory	Total fatigue score, range 20-100, 100 = worst fatigue	Baseline
Secondary	Pain catastrophizing scale	Total score 0-52, high values more catastrophizing	Baseline
Secondary	Beck Depression Inventory	Scores 0-63, with 63 highest depression	Baseline
Secondary	State-Trait Anxiety Inventory	Scores 20-80 for state and 20-80 for trait anxiety, higher levels indicate more anxiety	Baseline
Secondary	EuroQual-5D	Scale ranging from -0.224 to 1, with 1 being highest possible health related quality of life	Baseline