Status:
NOT_YET_RECRUITING
The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Surgical Methods Centre, McMaster University
Michael G. DeGroote Institute for Pain Research and Care
Conditions:
Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
The investigators will conduct a cluster-randomized, 2-arm, data analyst-blinded feasibility RCT at four Canadian CHCs. The CHCs will be paired on clinical characteristics (e.g., size of patient roste...
Eligibility Criteria
Inclusion
- Clusters
- CHC in Canada
- Roster of ≥ 3,500 patients
- One or more opioid-reducing strategies implemented as part of their standard medical services (e.g., chart audits, tracked performance metrics related to high dose prescribing)
- Participants
- Adult patients (aged ≥ 18 years)
- Diagnosis of chronic non-cancer spinal pain (i.e., back or neck pain of ≥ 12 weeks' duration, not associated with cancer)
- Actively receiving one or more opioid prescriptions (minimum dose of 50 mg MED, dispensed over a period of at least 3 consecutive months)
- Interested in reducing their opioid dose
- Cognitive ability and language skills required to complete the outcome measures
- Provision of informed consent
Exclusion
- Clusters
- • CHCs that employ chiropractors or have currently established chiropractic programs
- Participants
- Individuals already receiving chiropractic care
- Opioid-naive (or \< 90 consecutive days of opioid prescription) at baseline
- Total active opioid dosage of \< 50 mg MED at baseline
- Actively receiving treatment for opioid use disorder (e.g., methadone, naloxone)
- Spinal neoplasms or other 'red flag' diagnoses (e.g., fractures, infections, inflammatory arthritis, or cauda equina syndrome)
- Anticipated problems with the participant being available for follow-up (e.g., incarceration, or planned incarceration)
- The participant is or may be enrolled in a competing trial
- Prior enrolment in the ACCESS-DC trial
- Other reason to exclude the participant, as approved by the Methods Centre
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06160947
Start Date
April 1 2026
End Date
March 31 2028
Last Update
January 7 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
McMaster University
Hamilton, Ontario, Canada, L8S 4K1