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NCT Number: NCT05963451

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.

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Key information

Conditions

Chronic Low-back Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

Location status: Recruiting

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

    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).

  5. 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)

    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.

  6. 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").

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Number of traumatic events

    Time frame: Change 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.

  12. Patient Expectations score

    Time frame: This will be acquired 1 week before their treatment

    The investigators will use the EXPECT Questionnaire. Measured on numerical rating scale (0 = "no change" to 10 = "complete relief"). Higher score means better outcome.

  13. Change of Global Impression score

    Time frame: Change 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.

  14. 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.

  15. 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)

    The investigators will use a Short Gender Questionnaire (SGQ). Measured on a 5-point Likert-scale (1 = "not at all" to 5 = "extremely").

  16. 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)

    The investigators will acquire a saliva sample using a DNA kit to perform epigenetic analysis.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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