NCT Number: NCT05963451
The goal of this observational study is to better understand the role of the brain in chronic low back pain patients.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Sherbrooke, Quebec, J1H 5N4, Canada
Location status: Recruiting
Marylie Martel, PhD
CONTACT
+1 819 346-1110 ext. 12858
Pascal Tétreault, PhD
CONTACT
+1 819 821-8000 ext. 74502
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention will be given in our study since, the investigators are recruiting people who will receive already a facet thermal ablation.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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 (4 weeks before their treatment) and after their treatment (at 4 months post treatment)
The investigators will use the Life Events Checklist (LEC). We will count the number of traumatic events.
Time frame: This will be acquired 1 week before their treatment
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: Change from Baseline (at 2 months post treatment) and after 2 months (at 4 months post treatment)
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 (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
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)
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)
The investigators will acquire a saliva sample using a DNA kit to perform epigenetic analysis.
Contact information is provided by the study sponsor or research team.
Université de Sherbrooke
Other
Assessing the Predictability of Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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