An interventional study of Placebos and Waitlist in Back Pain, sponsored by Nova Scotia Health Authority. Enrolling by invitation at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Basic science
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).
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 250 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Chronic pain participant inclusion criteria:
Healthy participant inclusion criteria:
Exclusion Criteria:
Chronic pain participant exclusion criteria:
Healthy participant exclusion criteria:
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.
Other: Placebos
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.
Other: Waitlist
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.
Other: Healthy Controls
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.
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.
Healthy control participants will not receive a placebo drug or be put on a waitlist.
Pain modulation - using an experimental task that tests a person's ability to form positive expectations
Brain imaging will be used to assess each participant's capacity to endogenously adjust pain perception with changes in expectations.
Time frame: 3 days after first visit
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Nova Scotia Health Authority