Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
Study Details
Study Description
Brief Summary
The goal of this observational study is to better understand the role of the brain in chronic low back pain patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Chronic Low Back Pain (CLBP) group Participants who will took part in our study are people living with CLBP who will undergo facet thermal ablation treatment |
Other: No intervention
No intervention will be given in our study since, we are recruiting people who will receive already a facet thermal ablation.
|
Outcome Measures
Primary Outcome Measures
- Change of Grey matter volume [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)]
Grey matter volume (milliliters cube) will be measured by acquiring a T1weighted (T1w) image using Magnetic Resonance Imaging.
- Change of Blood-oxygen level dependent (BOLD) response [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)]
Blood-oxygen level dependent (BOLD) response will be measured by using functional Magnetic Resonance Imaging (fMRI).
- Change of Microstructural and connectivity properties of white matter tracts [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)]
Microstructural and connectivity properties will be measured by using diffusion Magnetic Resonance Imaging (dMRI).
- Change of Brain's arteries system [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)]
Brain vasculature will be measured by using Time-of-Flight Magnetic Resonance Angiography (ToF MRA).
- Change of Brain's venous system [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)]
Brain vasculature will be measured by using Susceptibility Weighted Imaging (SWI).
Secondary Outcome Measures
- Change of Pain Severity score [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)]
We will use the Brief Pain Inventory-short form (BPI-SF). Measured on a numerical rating scale (0 = no pain; 10= worst pain imaginable).
- Change of Pain Interference score [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)]
We will use the Brief Pain Inventory-short form (BPI-SF). Measured on a numerical rating scale (0 = no interference; 10=complete interference).
- Change of Pain Catastrophizing score [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)]
We will use the Pain Catastrophizing-short form (PCS-SF). Measured on a 5-point Likert-scale ("not at all" to "all the time").
- Change of Neuropathic pain components score [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)]
We will use the Pain detect. Seven items are measured on a rated on a 6-point Likert Scale (0=not at all, 5=very strongly), 1 item based on pain behavior pattern score (-1, 0 or 1) and 1 item based on a radiation score (0 or 2).
- Change of Global function score [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)]
We will use the Pain Outcomes Questionnaire (POQ). Measured on a numeric rating scale (0 = less symptoms to 10= more severe symptoms).
- Change of Anxiety score [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)]
We will use the State-Trait Anxiety Inventory (STAI-S/T). Measured on a 4-point Likert-scale ("not at all" to "all the time").
- Change of Depression score [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)]
We will use the Beck Depression Inventory (BDI). Measured on a 4-point Likert-scale ("less symptoms" to "more severe symptoms").
- Change of Fear of movement score [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)]
We will use the Tampa Scale of Kinesiophobia - short form (TSK-SF).Measured on a 4-point Likert-scale ("Strongly Disagree" to "Strongly Agree").
- Change of Functional disability score [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)]
We will use the Oswestry Disability Index (ODI). Measured on a 6-point Likert Scale ("less symptoms" to"more severe symptoms").
- Change of Insomnia severity score [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)]
We will use the Insomnia severity Index (ISI)
- Number of traumatic events [Change from Baseline (4 weeks before their treatment) and after their treatment (at 4 months post treatment)]
We will use the Life Events Checklist (LEC). We will count the number of traumatic events.
- Patient Expectations score [This will be acquired 1 week before their treatment]
We will use the EXPECT Questionnaire. Measured on numerical rating scale (NRS) (0 = no change to 10 = complete relief).
- Change of Global Impression score [Change from Baseline (at 2 months post treatment) and after 2 months (at 4 months post treatment)]
We will use the Patients' Global Impression of Change (PGIC) scale. Measured on numerical rating scale (NRS) (0 = no change to 10 = complete relief).
- Change Central sensitization component score [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)]
We will use the Central Sensitization Inventory - short form (CSI-SF). Measured on a 5-point Likert-scale (0 = "never" ; 4 = "always").
- Patient Gender score [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)]
We will use a Short Gender Questionnaire (SGQ). Measured on a 5-point Likert-scale (1 = "not at all" ; 5 = "extremely").
- Change Polygenic methylation score [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)]
We will acquire a saliva sample using a DNA kit to perform epigenetic analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Low back pain (≥ 6 months) with or without pain radiating to the legs or radiating to the neck
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Positive medial branch blocks, suggesting that the pain originates from the lumbar facet joints
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Average pain intensity of ≥ 3/10 in the 24-hour period before the initial visit
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Pain primarily localized in the lower back
Exclusion Criteria:
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Inadequate pain relief or relief of less than three months following selective thermoablation of medial lumbar branches by radiofrequency
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Neurological, cardiovascular, or pulmonary disorders
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Comorbid pain syndrome
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History of surgical intervention in the back
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A corticosteroid infiltration within the past year
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Pregnancy (current or planned during the course of the study)
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Contra-indication to Magnetic Resonance Imaging (MRI)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Université de Sherbrooke
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-4293