Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain

Université de Sherbrooke80 enrolled

Overview

The goal of this observational study is to better understand the role of the brain in chronic low back pain patients.

Chronic pain affects millions of people worldwide, and the main cardinal sign of any arthritis condition is pain. Several arthritis conditions can cause chronic low back pain (CLBP).The mechanisms that contribute to CLBP are not yet fully understood, but considering the role of the brain in the context of chronic pain, it is only logical to investigate structural and functional brain properties in CLBP, in order to improve diagnosis and treatment of this condition.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Low-back Pain

Interventions

No interventionOTHER

No intervention will be given in our study since, the investigators are recruiting people who will receive already a facet thermal ablation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Low back pain (≥ 6 months) with or without pain radiating to the legs or radiating to the neck * Positive medial branch blocks, suggesting that the pain originates from the lumbar facet joints * Average pain intensity of ≥ 3/10 in the 24-hour period before the initial visit * Pain primarily localized in the lower back Exclusion Criteria: * Inadequate pain relief or relief of less than three months following selective thermoablation of medial lumbar branches by radiofrequency * Neurological, cardiovascular, or pulmonary disorders * Comorbid pain syndrome * History of surgical intervention in the back * A corticosteroid infiltration within the past year * Pregnancy (current or planned during the course of the study) * Contra-indication to Magnetic Resonance Imaging (MRI)

Locations (1)

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS)

Sherbrooke, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

Change of Grey matter volume

Grey matter volume (milliliters cube) will be measured by acquiring a T1weighted (T1w) image using Magnetic Resonance Imaging.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Blood-oxygen level dependent (BOLD) response

Blood-oxygen level dependent (BOLD) response will be measured by using functional Magnetic Resonance Imaging (fMRI).

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Microstructural and connectivity properties of white matter tracts

Microstructural and connectivity properties will be measured by using diffusion Magnetic Resonance Imaging (dMRI).

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Brain's arteries system

Brain vasculature will be measured by using Time-of-Flight Magnetic Resonance Angiography (ToF MRA).

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Brain's venous system

Brain vasculature will be measured by using Susceptibility Weighted Imaging (SWI).

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Secondary Outcomes

Change of Pain Severity score

Central Contacts

Pascal Tétreault, PhD

CONTACT

819-346-1110 pascal.tetreault@usherbrooke.ca

Marylie Martel, PhD

CONTACT

marylie.martel@usherbrooke.ca

Data from ClinicalTrials.gov

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The investigators will use the Brief Pain Inventory-short form (BPI-SF). Measured on a numerical rating scale (0 = "no pain" to 10 = "worst pain imaginable"). Higher score means worse outcome.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Pain Interference score

The investigators will use the Brief Pain Inventory-short form (BPI-SF). Measured on a numerical rating scale (0 = "no interference" to 10 = "complete interference"). Higher score means worse outcome.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Pain Catastrophizing score

The investigators will use the Pain Catastrophizing-short form (PCS-SF). Measured on a 5-point Likert-scale (0 = "not at all" to 4 = "all the time"). Higher score means worse outcome.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Neuropathic pain components score

The investigators will use the Pain detect. Seven items are measured on a rated on a 6-point Likert Scale (0 = "not at all" to 5 = "very strongly"). Higher score means worse outcome. 1 item based on pain behavior pattern score (-1, 0 or 1) and 1 item based on a radiation score (0 or 2).

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Global function score

The investigators will use the Pain Outcomes Questionnaire (POQ). Measured on a numeric rating scale (0 = "less symptoms" to 10= "more severe symptoms"). Higher score means worse outcome.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Anxiety score

The investigators will use the State-Trait Anxiety Inventory (STAI-S/T). Measured on a 4-point Likert-scale (0 = "not at all" to 3 = "all the time").

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Depression score

The investigators will use the Beck Depression Inventory (BDI). Measured on a 4-point Likert-scale (0 = "less symptoms" to 3 = "more severe symptoms"). Higher score means worse outcome.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Fear of movement score

The investigators will use the Tampa Scale of Kinesiophobia - short form (TSK-SF).Measured on a 4-point Likert-scale (0 = "Strongly Disagree" to 3 = "Strongly Agree"). Higher score means worse outcome.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Functional disability score

The investigators will use the Oswestry Disability Index (ODI). Measured on a 6-point Likert Scale (0 = "less symptoms" to 5 = "more severe symptoms"). Higher score means worse outcome.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change of Insomnia severity score

The investigators will use the Insomnia severity Index (ISI). Measured on a 5-point Likert scale (0 = "not at all" to 4 = "extremely"). Higher score means worse outcome.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Number of traumatic events

The investigators will use the Life Events Checklist (LEC). We will count the number of traumatic events.

Time frame: Change from Baseline (4 weeks before their treatment) and after their treatment (at 4 months post treatment)

Patient Expectations score

The investigators will use the EXPECT Questionnaire. Measured on numerical rating scale (0 = "no change" to 10 = "complete relief"). Higher score means better outcome.

Time frame: This will be acquired 1 week before their treatment

Change of Global Impression score

The investigators will use the Patients' Global Impression of Change (PGIC) scale. Measured on numerical rating scale (0 = "no change" to 10 = "complete relief"). Higher score means better outcome.

Time frame: Change from Baseline (at 2 months post treatment) and after 2 months (at 4 months post treatment)

Change Central sensitization component score

The investigators will use the Central Sensitization Inventory - short form (CSI-SF). Measured on a 5-point Likert-scale (0 = "never" to 4 = "always"). Higher score means worse outcome.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Patient Gender score

The investigators will use a Short Gender Questionnaire (SGQ). Measured on a 5-point Likert-scale (1 = "not at all" to 5 = "extremely").

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)

Change Polygenic methylation score

The investigators will acquire a saliva sample using a DNA kit to perform epigenetic analysis.

Time frame: Change from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)