Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
ID: NCT05963451
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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.
Read Full Scientific Objectives & Methods
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.
No intervention will be given in our study since, the investigators are recruiting people who will receive already a facet thermal ablation.
Treatment Arms Description
Participants who will took part in our study are people living with CLBP who will undergo facet thermal ablation treatment
- 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
- 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)
Primary Outcome Measures
- Change of Grey matter volume — 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.
- Change of Blood-oxygen level dependent (BOLD) response — 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).
- Change of Microstructural and connectivity properties of white matter tracts — 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).
- Change of Brain's arteries system — 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).
- Change of Brain's venous system — 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).
View Secondary Outcome Measures (16)
- Change of Pain Severity score — 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.
- Change of Pain Interference score — 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.
- Change of Pain Catastrophizing score — 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.
- Change of Neuropathic pain components score — 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).
- Change of Global function score — 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.
- Change of Anxiety score — 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").
- Change of Depression score — 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.
- Change of Fear of movement score — 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.
- Change of Functional disability score — 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.
- Change of Insomnia severity score — 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.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
Assessing the Predictability of Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain