Brain Imaging Study for Chronic Back Pain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Cardiac, Respiratory, Nervous diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study proposes to investigate the factors related to a person that can enhance or reduce the effectiveness of pain treatments in people suffering with chronic pain. Treatment response to pain killers in a person may be related to their brain, genetics, social, and psychological makeup. The investigators aim to study these factors to identify and develop feasible and robust indicators based on a person's biological makeup (also called biomarkers).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

Is MRI safe for humans in the context of chronic back pain studies?

MRI (Magnetic Resonance Imaging) is generally considered safe for humans and has no known physical side effects, as mentioned in studies related to low back pain. ^{1 2 3 4 5}

How does this treatment for chronic back pain differ from other treatments?

This treatment is unique because it uses advanced brain imaging techniques to understand and address changes in the brain associated with chronic back pain, rather than focusing solely on the physical aspects of the condition. This approach aims to improve diagnosis and treatment by targeting the brain's role in pain perception and processing. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Brain Imaging Study for chronic back pain?

Research shows that brain imaging techniques can help understand how chronic pain affects the brain and may serve as markers to track and treat pain more effectively. These techniques could potentially link patients to the most effective therapies for their pain conditions by detecting changes in brain function. ^{11 12 13 14 15}

Who Is on the Research Team?

Javeria A Hashmi, PhD

Principal Investigator

Dalhousie University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with chronic low back pain lasting over 6 months and experiencing moderate pain. Participants must be right-handed, comfortable with English, and able to undergo MRI scans without contraindications like metal implants or claustrophobia. Healthy volunteers matching the age and hand dominance criteria but without pain or significant health issues can also join.

Inclusion Criteria

I have had chronic low back pain for more than 6 months.

Chronic pain participant: Comfortable completing (reading and writing) questionnaires and tasks with English language instructions

You are right-handed.

Exclusion Criteria

I do not have any ongoing pain issues.

You cannot have an MRI scan if you have a pacemaker, metal implants, fear of closed spaces, or are pregnant.

Healthy participant: History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment and by asking the participant about their comfort level and ability, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Data Collection

Data collected in several experimental domains for studying treatment expectations (cognitive, psychosocial, brain-related, genetic)

Varies

Placebo Trial

Chronic Back Pain participants receive a mock drug (placebo) to test the clinical usefulness of the biomarkers

3 days

Daily reporting

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brain Imaging Study

Trial Overview The study is exploring how brain imaging can reveal biomarkers related to chronic back pain treatment effectiveness. It involves comparing responses of individuals on placebos, those on a waitlist, and healthy controls to understand the influence of biological, psychological, and social factors.

How Is the Trial Designed?

Group I: Waitlist Experimental Treatment 1 Intervention

Chronic Back Pain participants will not be given any placebo and will be requested to report their pain on paper forms organized as a calendar.

Group II: Placebos Experimental Treatment 1 Intervention

Chronic Back Pain participants will enter an optional placebo trial. This phase of the study will test the clinical usefulness of the biomarkers. We will measure how expectation of starting a new treatment reduces 'clinical back pain' in each participant. Positive treatment expectations will be induced by giving them capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Back Pain. They will be requested to take two capsules twice a day and report their pain on paper forms organized as a calendar.

Group III: Healthy Controls Experimental Treatment 1 Intervention

Healthy control participants will complete the main part of the study, but will not be asked to take a placebo or be placed on a waitlist.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

Brain imaging techniques have the potential to identify changes in the brain that could serve as biomarkers for chronic pain, which may improve drug development and treatment strategies for patients.

Future research should focus on imaging ongoing pain to enhance our understanding of brain function in various pain conditions and how different treatments affect these states.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers for chronic pain and analgesia. Part 2: how, where, and what to look for using functional imaging. Borsook, D., Becerra, L., Hargreaves, R.[2015]

Recent advances in brain-imaging techniques have improved our understanding of how chronic pain impacts various brain functions, including sensory, emotional, cognitive, and modulatory aspects.

Using brain imaging as a clinical tool could provide objective measures of disease state and treatment efficacy, potentially enhancing the management of chronic pain in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How close are we in utilizing functional neuroimaging in routine clinical diagnosis of neuropathic pain? Borsook, D., Becerra, L.[2021]

Chronic low back pain (LBP) is associated with significant changes in brain structure and connectivity, as shown by differences in cortical thickness and resting-state functional connectivity in a study of 24 LBP patients compared to 27 healthy controls.

Machine learning analysis of cortical thickness data achieved a classification accuracy of 74.51%, suggesting that these brain changes could serve as biomarkers to help guide more effective treatments for LBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-modal biomarkers of low back pain: A machine learning approach. Lamichhane, B., Jayasekera, D., Jakes, R., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Biomarkers for chronic pain and analgesia. Part 2: how, where, and what to look for using functional imaging. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Do sensorimotor cortex activity, an individual's capacity for neuroplasticity, and psychological features during an episode of acute low back pain predict outcome at 6 months: a protocol for an Australian, multisite prospective, longitudinal cohort study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Multimodal Approach to Pain Management for Patients with Chronic Back Pain: Outcome Measures at 1 Year. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

How close are we in utilizing functional neuroimaging in routine clinical diagnosis of neuropathic pain? [2021]

5. Japan pubmed.ncbi.nlm.nih.gov

Attenuation of cortical activity triggering descending pain inhibition in chronic low back pain patients: a functional magnetic resonance imaging study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

The catastrophization effects of an MRI report on the patient and surgeon and the benefits of 'clinical reporting': results from an RCT and blinded trials. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Abnormal findings on magnetic resonance imaging in a group of motor vehicle accident patients with low back pain. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging of the Lumbar Spine: Recommendations for Acquisition and Image Evaluation from the BACPAC Spine Imaging Working Group. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Is there a causal relationship between acute stage sensorimotor cortex activity and the development of chronic low back pain? a protocol and statistical analysis plan. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Routine versus needs-based MRI in patients with prolonged low back pain: a comparison of duration of treatment, number of clinical contacts and referrals to surgery. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating Cortical Alterations in Patients With Chronic Back Pain Using Neuroimaging Techniques: Recent Advances and Perspectives. [2020]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Neuroimaging the pain network - Implications for treatment. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Differential Neural Processing during Motor Imagery of Daily Activities in Chronic Low Back Pain Patients. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Brain structure, psychosocial, and physical health in acute and chronic back pain: a UK Biobank study. [2023]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Multi-modal biomarkers of low back pain: A machine learning approach. [2021]