Clinical trial NCT06160947: The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study
Official title: Impact of Chiropractic Care on Opioid Use Among Adults With Chronic Non-Cancer Spinal Pain: A Pilot Cluster Randomized Controlled Trial (ACCESS-DC Pilot)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Back Pain
Keywords: Clinical trials, randomized
Feasibility study
Analgesics, opioid
Chiropractic
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Surgical Methods Centre, McMaster University
name: Michael G. DeGroote Institute for Pain Research and Care
name: Ontario Chiropractic Association
name: Alliance for Healthier Communities
name: Michael G. DeGroote National Pain Centre
name: Canadian Chiropractic Research Foundation
name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-12-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized, 2-arm, data analyst-blinded feasibility trial
Primary purpose: TREATMENT

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 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.

Detailed description: The investigators will conduct a cluster-randomized, 2-arm, data analyst-blinded feasibility RCT at four Ontario CHCs. The CHCs will be paired on clinical characteristics (e.g., size of patient roster, geographic location), and one center from each pair will be randomized to the intervention and control groups. At each of the four centers, the investigators will recruit adult patients with active opioid prescriptions for chronic non-cancer spinal pain (minimum dose of 50 mg morphine equivalents daily) who are not currently receiving chiropractic care and are interested in reducing their opioid dose. Each center (cluster) will be allocated to provide 12 weeks of usual medical care plus chiropractic care or usual medical care alone to enrolled participants. Random cluster allocation will be performed by an investigator blinded to the intervention group assignment. To further minimize the possibility of selection bias, clusters will be identified and recruited before randomization, and all eligible (and consenting) patients in each cluster will be included. The pilot trial will be coordinated by the Methods Centre within the Department of Surgery at McMaster University.

The primary aims of this study will be to: (1) estimate recruitment rates at the individual centers, (2) explore adherence to the study protocol, (3) investigate completeness of data collection, and (4) assess the ability to follow-up participants. The investigators will incorporate qualitative methods during the pilot trial (i.e., convergent, mixed methods experimental design) to complement the feasibility measures. The investigators will also collect preliminary data on the outcomes planned for a definitive trial: opioid use, pain, disability, bothersomeness, satisfaction, and quality of life at 6, 12, 18, and 26 weeks from enrolment.

Eligibility criteria: Inclusion Criteria:

Clusters

* CHC in Ontario, 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
* 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

Primary outcomes:
measure: Participant Enrolment
timeFrame: From start of enrollment up to 26 weeks (or study end)
measure: Treatment Allocation
timeFrame: Baseline, 6-, 12-, 18- and 26-week follow-up
measure: Refinement of Data Collection Methods
timeFrame: Baseline, 6-, 12-, 18- and 26-week follow-up
measure: Compliance with the Protocol
timeFrame: Baseline, 6-, 12-, 18- and 26-week follow-up
Secondary outcomes:
measure: Daily Prescribed Opioid Dosage
timeFrame: Baseline, 6-, 12-, 18- and 26-week follow-up
measure: Risk of Higher-Dose Opioid Prescriptions
timeFrame: Baseline, 6-, 12-, 18- and 26-week follow-up
measure: Number of Opioid Prescriptions
timeFrame: Baseline, 6-, 12-, 18- and 26-week follow-up
measure: Level of Pain Intensity, and Physical and Emotional Functioning as measured by the Bournemouth Questionnaire (BQ)
timeFrame: Baseline, 6-, 12-, 18- and 26-week follow-up
measure: Level of Bothersomeness of Spinal Pain
timeFrame: Baseline, 6-, 12-, 18- and 26-week follow-up
measure: Level of Patient Satisfaction
timeFrame: 6-, 12-, 18- and 26-week follow-up
measure: Quality of Life as measured by the EuroQol 5 Domain (EQ-5D) (5 Level Version)
timeFrame: Baseline, 6-, 12-, 18- and 26-week follow-up
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Peter C Emary, DC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Jason W Busse, DC, PhD
role: STUDY_DIRECTOR
References: