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

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

Detailed Description
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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.

Official Title
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Assessing the Predictability of Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Low Back Pain (CLBP) group<br>Participants who will took part in our study are people living with CLBP who will undergo facet thermal ablation treatment | Other: No intervention<br>* No intervention will be given in our study since, the investigators are recruiting people who will receive already a facet thermal ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Grey matter volume | Grey matter volume (milliliters cube) will be measured by acquiring a T1weighted (T1w) image using Magnetic Resonance Imaging. | 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). | 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). | 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). | 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). | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain Severity score | 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. | 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. | 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. | 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). | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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) |