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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how factors such as brain activity, genetics, and social influences impact the effectiveness of pain treatments for individuals with chronic back pain. Participants will assist researchers in identifying biological markers—specific traits in the body—that can predict treatment success. The study includes brain imaging to visualize brain activity and involves a group taking placebo pills to assess how expectation influences pain relief. It seeks individuals who have experienced low back pain for over six months and can easily complete forms in English. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future pain treatments.

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.

What prior data suggests that this brain imaging study is safe?

Research has shown that placebo treatments can be safe and well-tolerated for people with chronic back pain. In studies, many patients taking a placebo reported significantly reduced pain. For instance, some experienced a 30% reduction in pain, while others reported a 50% reduction. Importantly, no long-term negative effects resulted from taking placebos. This suggests that placebo treatment is generally safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this brain imaging study for chronic back pain because it could reveal new insights into how pain is processed in the brain, potentially leading to better treatment strategies. Unlike conventional treatments like pain medications and physical therapy, this study focuses on understanding the brain's role in pain perception. By observing changes in the brain when patients expect to receive treatment, scientists aim to identify biomarkers that could predict treatment success. This could pave the way for more personalized and effective approaches to managing chronic back pain in the future.

What evidence suggests that this trial's treatments could be effective for chronic back pain?

Research has shown that placebo treatments can surprisingly help reduce chronic back pain. In one study, 45.4% of people taking a placebo reported a 30% reduction in pain. Another study found that even when patients knew they were taking a placebo, they still experienced about a 30% decrease in pain and disability. In this trial, some participants with chronic back pain will enter an optional placebo phase to test the clinical usefulness of biomarkers. Placebos have also improved mood, sleep, and the brain's pain processing. This suggests that simply expecting relief can greatly influence the perception of pain. ^{1 2 4 6 7}

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

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8518410/

Placebo effects in low back pain: A systematic review and ... This review shows a significant contribution of placebo effects to chronic LBP symptom relief in clinical and experimental conditions.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823541

Open-Label Placebo Injection for Chronic Back Pain With ... Of 44 patients randomized to OLP followed up at post-treatment, 20 (45.4%) reported 30% pain reduction and 11 (24.4%) reported 50% pain reduction. Of 47 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5113234/

Open-label placebo treatment in chronic low back pain After being given OLP for 3 weeks, participants in TAU who had entered the follow-up showed significant pain relief on all outcome measures (P ≤ 0.001 for each) ...

4. news.cuanschutz.edu news.cuanschutz.edu/news-stories/placebos-can-alleviate-chronic-back-pain-even-when-patients-know-theyre-placebos

Placebos Can Alleviate Chronic Back Pain, Even When ... Results indicate that the placebo treatment not only reduced pain intensity, but also improved mood, sleep and pain regulation in the brain, ...

5. wolterskluwer.com wolterskluwer.com/en/news/placebo-reduces-back-pain-even-when-patients-know-they-re-taking-placebo

Placebo Reduces Back Pain—Even When Patients Know ... Overall, open placebo treatment reduced initial pain and disability scores by approximately 30 percent. Patients in the usual-treatment group had similar ...

6. nature.com nature.com/articles/s41591-025-03977-0

Full-spectrum extract from Cannabis sativa DKJ127 for ... In conclusion, this phase 3 study provides robust evidence supporting the efficacy and safety of VER-01 in the treatment of CLBP. These findings ...

7. journals.lww.com journals.lww.com/pain/fulltext/2023/03000/no_long_term_effects_after_a_3_week_open_label.18.aspx

No long-term effects after a 3-week open-label placebo... Over the 3-year period, there were no differences in any outcome between groups with and without open-label placebo treatment. Therefore, our follow-up data do ...