Clinical trial NCT05963451: Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
Official title: Assessing the Predictability of Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Low-back Pain
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -People with CLBP who will have a thermoablation of medial lumbar branches by radiofrequency

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change of Grey matter volume
timeFrame: 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)
measure: Change of Blood-oxygen level dependent (BOLD) response
timeFrame: 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)
measure: Change of Microstructural and connectivity properties of white matter tracts
timeFrame: 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)
measure: Change of Brain's arteries system
timeFrame: 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)
measure: Change of Brain's venous system
timeFrame: 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)
Secondary outcomes:
measure: Change of Pain Severity score
timeFrame: 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)
measure: Change of Pain Interference score
timeFrame: 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)
measure: Change of Pain Catastrophizing score
timeFrame: 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)
measure: Change of Neuropathic pain components score
timeFrame: 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)
measure: Change of Global function score
timeFrame: 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)
measure: Change of Anxiety score
timeFrame: 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)
measure: Change of Depression score
timeFrame: 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)
measure: Change of Fear of movement score
timeFrame: 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)
measure: Change of Functional disability score
timeFrame: 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)
measure: Change of Insomnia severity score
timeFrame: 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)
measure: Number of traumatic events
timeFrame: Change from Baseline (4 weeks before their treatment) and after their treatment (at 4 months post treatment)
measure: Patient Expectations score
timeFrame: This will be acquired 1 week before their treatment
measure: Change of Global Impression score
timeFrame: Change from Baseline (at 2 months post treatment) and after 2 months (at 4 months post treatment)
measure: Change Central sensitization component score
timeFrame: 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)
measure: Patient Gender score
timeFrame: 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)
measure: Change Polygenic methylation score
timeFrame: 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)
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS)
state: Quebec
Study officials:
References: