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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963451
• Other study ID #: 2022-4293
• Status: Recruiting
• Start date: September 7, 2023
• Est. completion date: July 16, 2027

Study information

• Verified date: August 2023
• Source: Université de Sherbrooke
• Contact: Pascal Tétreault, PhD
• Phone: 819-346-1110
• Email: pascal.tetreault[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 16, 2027
• Est. primary completion date: July 16, 2027
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS)	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Grey matter volume	Grey matter volume (milliliters cube) will be measured by acquiring a T1weighted (T1w) image using Magnetic Resonance Imaging.	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)
Primary	Change of Blood-oxygen level dependent (BOLD) response	Blood-oxygen level dependent (BOLD) response will be measured by using functional Magnetic Resonance Imaging (fMRI).	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)
Primary	Change of Microstructural and connectivity properties of white matter tracts	Microstructural and connectivity properties will be measured by using diffusion Magnetic Resonance Imaging (dMRI).	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)
Primary	Change of Brain's arteries system	Brain vasculature will be measured by using Time-of-Flight Magnetic Resonance Angiography (ToF MRA).	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)
Primary	Change of Brain's venous system	Brain vasculature will be measured by using Susceptibility Weighted Imaging (SWI).	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	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.	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	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.	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	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.	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	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).	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	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.	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	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").	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	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.	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	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.	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	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.	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	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.	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	Number of traumatic events	The investigators will use the Life Events Checklist (LEC). We will count the number of traumatic events.	Change from Baseline (4 weeks before their treatment) and after their treatment (at 4 months post treatment)
Secondary	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.	This will be acquired 1 week before their treatment
Secondary	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.	Change from Baseline (at 2 months post treatment) and after 2 months (at 4 months post treatment)
Secondary	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.	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	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").	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	Change Polygenic methylation score	The investigators will acquire a saliva sample using a DNA kit to perform epigenetic analysis.	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)