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NCT06160947
The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study
Conditions: Back Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: McMaster University
Location: McMaster University Hamilton Ontario
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 therapy for chronic non-cancer spinal pain at four community health centers (CHCs) in 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 Canadian CHC context.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
* 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
Source: ClinicalTrials.gov (NCT06160947). StuddyBuddy aggregates publicly available trial information.