NCT02991625

Brain Imaging Study on Biomarkers for Chronic Back Pain

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

Drugs used for managing chronic pain have not proven to be effective and chronic pain continues to cost Canadians $60 billion a year without truly helping those who suffer. 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). These biomarkers will allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people. These measures will offer new opportunities for improving treatment such as by tailoring treatment to meet the specific needs of each patient based on his/her biological and psychological makeup. Towards the specific aim, data will first be collected in several experimental domains for studying treatment expectations (cognitive, psychosocial, brain-related, genetic). These 'experimental' data will be compared between chronic back pain (CBP) and healthy participants to yield new understanding of the factors that govern treatment response. At the end of experimental data collection, the investigators will collect data in the 'clinical' domain. Hence, at the end of the experimental sessions, a subset of CBP participants will receive a mock drug (placebo disguised as an approved pain treatment) and another subset will provide pain ratings only and hence serve as a waiting list control for the placebo trial. Data will be studied in steps to understand factors that mediate treatment outcomes and finally the investigators will use advanced computational tools used for big data analysis and aim to identify factors that can be used as biomarkers and precision medicine tools.

Conditions

• Back Pain

Interventions

Type	Name	Description
OTHER	Placebos	Positive treatment expectations will be induced by giving participants 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.
OTHER	Waitlist	These Chronic Back Pain participants will not be given any placebos and will be requested to report their pain on paper forms organized as a calendar.
OTHER	Healthy Controls	Healthy control participants will not receive a placebo drug or be put on a waitlist.

Timeline

• Start date: 2018-01-22
• Primary completion: 2027-01-01
• Completion: 2035-01-01
• First posted: 2016-12-13
• Last updated: 2025-02-17

Locations

1 site across 1 country: Canada