Trial Summary
What is the purpose of this trial?The investigators will conduct a pilot cluster randomized controlled trial (RCT) of chiropractic care added to usual medical care, versus usual medical care alone, for adult patients prescribed opioid therapy for chronic non-cancer spinal pain at four community health centers (CHCs) in Ontario, Canada. These centers provide services to communities and vulnerable populations with high unemployment rates, multiple co-morbidities, and high rates of chronic musculoskeletal disorders that are commonly managed with prescription opioids.
The investigators hypothesize that a full-scale (definitive) cluster RCT on the impact of chiropractic care on prescription opioid use for chronic non-cancer spinal pain will be feasible within the Ontario CHC context.
Eligibility Criteria
This trial is for adults in Ontario with chronic non-cancer spinal pain who have been on opioids for at least 3 months and are interested in reducing their opioid use. They must be able to understand the study and give informed consent. People already getting chiropractic care, using low-dose opioids, treated for opioid misuse, or with certain serious spine conditions can't join.Exclusion Criteria
I am currently receiving chiropractic treatments.
Treatment Details
The study tests if adding chiropractic care to usual medical treatments helps reduce opioid use more than usual medical treatments alone. It's a pilot randomized controlled trial conducted at community health centers serving high-need areas.
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Medical Care + Chiropractic CareExperimental Treatment1 Intervention
This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care plus chiropractic care.
Group II: Usual Medical CareActive Control1 Intervention
This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care.
Chiropractic Care is already approved in United States, Canada, Australia, European Union for the following indications:
🇺🇸 Approved in United States as Chiropractic Care for:
- Musculoskeletal disorders
- Neck pain
- Back pain
- Headaches
🇨🇦 Approved in Canada as Chiropractic Care for:
- Musculoskeletal disorders
- Neck pain
- Back pain
- Headaches
🇦🇺 Approved in Australia as Chiropractic Care for:
- Musculoskeletal disorders
- Neck pain
- Back pain
- Headaches
🇪🇺 Approved in European Union as Chiropractic Care for:
- Musculoskeletal disorders
- Neck pain
- Back pain
- Headaches
Find a clinic near you
Research locations nearbySelect from list below to view details:
McMaster UniversityHamilton, Canada
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Who is running the clinical trial?
McMaster UniversityLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
Canadian Chiropractic Research FoundationCollaborator
Ontario Chiropractic AssociationCollaborator
Alliance for Healthier CommunitiesCollaborator
Surgical Methods Centre, McMaster UniversityCollaborator
Michael G. DeGroote Institute for Pain Research and CareCollaborator
Michael G. DeGroote National Pain CentreCollaborator