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

NCT ID: NCT04934917

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-28
• Study Completion Date: 2021-07-01

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).

Conditions

Degenerative Disc Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with disc degenerative disease (DDD)

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.

Magnetic Resonance Imaging

Intervention Type: DEVICE

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

Healthy controls (HC)

Healthy controls matched according to age and sex, no chronic pain conditions.

Magnetic Resonance Imaging

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Eva Kosek

Principal Investigator, Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Kosek, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institute

Stockholm, , Sweden

Karolinska Insitutet

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2019-01142_1pre

Identifier Type: -

Identifier Source: org_study_id