An observational study in Chronic Low-back Pain, sponsored by Université de Sherbrooke. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Université de Sherbrooke · Observational
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 357 observational studies indexed under Back Pain.
Browse Back Pain studies →Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
-People with CLBP who will have a thermoablation of medial lumbar branches by radiofrequency
Exclusion Criteria:
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, the investigators are recruiting people who will receive already a facet thermal ablation.
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)
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.
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)
Plan to share: No
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Université de Sherbrooke