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Not Yet Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06160947). StuddyBuddy aggregates publicly available trial information.