The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study (ACCESS-DC)

McMaster University

Status: Begins enrollment in 1 month

Conditions: Back Pain

Treatments: Other: Usual Medical Care; Other: Usual Medical Care + Chiropractic Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06160947

17-2023

Details and patient eligibility

About

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.

Full 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 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 26 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Usual Medical Care

Active Comparator group

Description:

This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care.

Treatment:

Other: Usual Medical Care

Usual Medical Care + Chiropractic Care

Experimental group

Description:

This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care plus chiropractic care.

Treatment:

Other: Usual Medical Care + Chiropractic Care