Chronic Low-back PainNCT05963451
Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
An observational study of Chronic Low-back Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The goal of this observational study is to better understand the role of the brain in chronic low back pain patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low-back Pain
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2023to 16 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: -People with CLBP who will have a thermoablation of medial lumbar branches by radiofrequency
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marylie Martel, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS)
Sherbrooke, Quebec, J1H 5N4
Pascal Tétreault, PhD, +1 819 821-8000 ext. 74502, pascal.tetreault@usherbrooke.ca
Marylie Martel, PhD, +1 819 346-1110 ext. 12858, marylie.martel@usherbrooke.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be given in our study since, the investigators are recruiting people who will receive already a facet thermal ablation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Grey matter volume
Grey matter volume (milliliters cube) will be measured by acquiring a T1weighted (T1w) image using Magnetic Resonance Imaging.
Measured: 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
Blood-oxygen level dependent (BOLD) response will be measured by using functional Magnetic Resonance Imaging (fMRI).
Measured: 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
Microstructural and connectivity properties will be measured by using diffusion Magnetic Resonance Imaging (dMRI).
Measured: 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 arteries system
Brain vasculature will be measured by using Time-of-Flight Magnetic Resonance Angiography (ToF MRA).
Measured: 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
Brain vasculature will be measured by using Susceptibility Weighted Imaging (SWI).
Measured: 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 (16)
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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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).
Measured: 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 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.
Measured: 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 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").
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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)
Number of traumatic events
The investigators will use the Life Events Checklist (LEC). We will count the number of traumatic events.
Measured: Change from Baseline (4 weeks before their treatment) and after their treatment (at 4 months post treatment)
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.
Measured: This will be acquired 1 week before their treatment
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.
Measured: Change from Baseline (at 2 months post treatment) and after 2 months (at 4 months post treatment)
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.
Measured: 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)
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").
Measured: 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 Polygenic methylation score
The investigators will acquire a saliva sample using a DNA kit to perform epigenetic analysis.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start7 Sep 2023 (estimated)
- Primary completion16 Jul 2027 (estimated)
- Study completion16 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963451
- Sponsor's protocol ID
- 2022-4293
- Status last verified
- Aug 2023
- First submitted
- 10 Jul 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Predictability of Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05963451
- Acronym / sponsor ID
- 2022-4293
- Conditions
- Chronic Low-back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 7 Sep 2023 (estimated)
- Primary completion
- 16 Jul 2027 (estimated)
- Study completion
- 16 Jul 2027 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Low Back Pain (CLBP) group | – | Other: No interventionParticipants who will took part in our study are people living with CLBP who will undergo facet thermal ablation treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- -People with CLBP who will have a thermoablation of medial lumbar branches by radiofrequency
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention will be given in our study since, the investigators are recruiting people who will receive already a facet thermal ablation. | Other | Chronic Low Back Pain (CLBP) group |
Primary outcome
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).
16 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Number of traumatic events
Time frame: Change from Baseline (4 weeks before their treatment) and after their treatment (at 4 months post treatment)
Patient Expectations score
Time frame: This will be acquired 1 week before their treatment
Change of Global Impression score
Time frame: Change from Baseline (at 2 months post treatment) and after 2 months (at 4 months post treatment)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marylie Martel, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascal Tétreault, PhD (819-346-1110 ext. 12858, pascal.tetreault@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.