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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05963451
Enrollment
80
Registered
2023-07-27
Start date
2023-09-07
Completion date
2027-07-16
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain

Brief summary

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

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.

Interventions

OTHERNo intervention

No intervention will be given in our study since, the investigators are recruiting people who will receive already a facet thermal ablation.

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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)

Design outcomes

Primary

MeasureTime frameDescription
Change of Grey matter volumeChange 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) responseChange 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 tractsChange 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 systemChange 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 systemChange 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

MeasureTime frameDescription
Change of Anxiety scoreChange 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 scoreChange 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 scoreChange 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 scoreChange 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 scoreChange 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.
Change of Pain Severity scoreChange 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.
Patient Expectations scoreThis will be acquired 1 week before their treatmentThe investigators will use the EXPECT Questionnaire. Measured on numerical rating scale (0 = no change to 10 = complete relief). Higher score means better outcome.
Change of Global Impression scoreChange 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.
Change Central sensitization component scoreChange 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.
Patient Gender scoreChange 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).
Change Polygenic methylation scoreChange 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.
Number of traumatic eventsChange 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.
Change of Pain Interference scoreChange 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 scoreChange 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 scoreChange 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 scoreChange 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.

Countries

Canada

Contacts

Primary ContactPascal Tétreault, PhD
pascal.tetreault@usherbrooke.ca819-346-1110
Backup ContactMarylie Martel, PhD
marylie.martel@usherbrooke.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026