- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05963451
Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
September 11, 2023 updated by: Université de Sherbrooke
Assessing the Predictability of Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
The goal of this observational study is to better understand the role of the brain in chronic low back pain patients.
Study Overview
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.
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pascal Tétreault, PhD
- Phone Number: 12858 819-346-1110
- Email: pascal.tetreault@usherbrooke.ca
Study Contact Backup
- Name: Marylie Martel, PhD
- Email: marylie.martel@usherbrooke.ca
Study Locations
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- Recruiting
- Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS)
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Contact:
- Pascal Tétreault, PhD
- Phone Number: 74502 +1 819 821-8000
- Email: pascal.tetreault@usherbrooke.ca
-
Contact:
- Marylie Martel, PhD
- Phone Number: 12858 +1 819 346-1110
- Email: marylie.martel@usherbrooke.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
-People with CLBP who will have a thermoablation of medial lumbar branches by radiofrequency
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic Low Back Pain (CLBP) group
Participants who will took part in our study are people living with CLBP who will undergo facet thermal ablation treatment
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No intervention will be given in our study since, the investigators are recruiting people who will receive already a facet thermal ablation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
|
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 from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
|
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).
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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)
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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).
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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)
|
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).
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
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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 from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
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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.
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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)
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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)
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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).
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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)
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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)
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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)
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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").
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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)
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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 from Baseline (1 week, 2 months and 4 months before their treatment) and after their treatment (at 2 months and 4 months post treatment)
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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.
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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)
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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.
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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)
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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.
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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)
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Number of traumatic events
Time Frame: Change from Baseline (4 weeks before their treatment) and after their treatment (at 4 months post treatment)
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The investigators will use the Life Events Checklist (LEC).
We will count the number of traumatic events.
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Change from Baseline (4 weeks before their treatment) and after their treatment (at 4 months post treatment)
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Patient Expectations score
Time Frame: This will be acquired 1 week before their treatment
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The investigators will use the EXPECT Questionnaire.
Measured on numerical rating scale (0 = "no change" to 10 = "complete relief").
Higher score means better outcome.
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This will be acquired 1 week before their treatment
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Change of Global Impression score
Time Frame: Change from Baseline (at 2 months post treatment) and after 2 months (at 4 months post treatment)
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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.
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Change from Baseline (at 2 months post treatment) and after 2 months (at 4 months post treatment)
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Change Central sensitization component 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 Central Sensitization Inventory - short form (CSI-SF).
Measured on a 5-point Likert-scale (0 = "never" to 4 = "always").
Higher score means worse outcome.
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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)
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Patient Gender 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)
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The investigators will use a Short Gender Questionnaire (SGQ).
Measured on a 5-point Likert-scale (1 = "not at all" to 5 = "extremely").
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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)
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Change Polygenic methylation 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)
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The investigators will acquire a saliva sample using a DNA kit to perform epigenetic analysis.
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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 7, 2023
Primary Completion (Estimated)
July 16, 2027
Study Completion (Estimated)
July 16, 2027
Study Registration Dates
First Submitted
July 10, 2023
First Submitted That Met QC Criteria
July 18, 2023
First Posted (Actual)
July 27, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-4293
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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