The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study

NCT06160947 | Not Yet Recruiting

• 1 other identifier: 17-2023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Back Pain

Keywords

Clinical trials, randomized; Feasibility study; Analgesics, opioid; Chiropractic

Outcome Measures

Primary Outcomes (4)

• Participant Enrolment

  Participant enrolment will be assessed by monitoring screening and enrolment metrics, including: 1) initiation of screening and recruitment at CHCs, 2) proportion of eligible patients approached for participation, 3) proportion of patients who provide informed consent, and 4) length of time required to enrol approximately six participants at each CHC. All outcome measures will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).

  From start of enrollment up to 26 weeks (or study end)

• Treatment Allocation

  Feasibility of the treatment allocation will be assessed using the following metrics: 1) adherence to chiropractic care in addition to usual medical care allocation, and 2) adherence to usual medical care allocation. All outcome measures will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).

  Baseline, 6-, 12-, 18- and 26-week follow-up

• Refinement of Data Collection Methods

  To refine the data collection methods, the following metrics will be reviewed: 1) proportion of participants with missing data for the primary clinical outcome, and 2) proportion of case report forms with missing data for the participant-reported outcomes (BQ, Bothersomeness questionnaire, EQ-5D-5L, and patient satisfaction). All outcome measures will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).

  Baseline, 6-, 12-, 18- and 26-week follow-up

• Compliance with the Protocol

  The following outcomes will be used to assess compliance with the protocol: 1) participant compliance with scheduled appointments, 2) proportion of participants who complete each follow-up visit, 3) proportion of participants who withdraw consent to participate in the trial, and 4) proportion of participants who cannot be located. All outcomes will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).

  Baseline, 6-, 12-, 18- and 26-week follow-up

Secondary Outcomes (7)

• Daily Prescribed Opioid Dosage

  Baseline, 6-, 12-, 18- and 26-week follow-up

• Risk of Higher-Dose Opioid Prescriptions

  Baseline, 6-, 12-, 18- and 26-week follow-up

• Number of Opioid Prescriptions

  Baseline, 6-, 12-, 18- and 26-week follow-up

• Level of Pain Intensity, and Physical and Emotional Functioning as measured by the Bournemouth Questionnaire (BQ)

  Baseline, 6-, 12-, 18- and 26-week follow-up

• Level of Bothersomeness of Spinal Pain

  Baseline, 6-, 12-, 18- and 26-week follow-up

Study Arms (2)

Usual Medical Care

ACTIVE COMPARATOR

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

Other: Usual Medical Care

Usual Medical Care + Chiropractic Care

EXPERIMENTAL

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

Other: Usual Medical Care + Chiropractic Care

Interventions

Usual Medical Care OTHER

In both the intervention and control arms of the study, usual medical care will be defined as any and all medical care provided to patients with chronic non-cancer back or neck pain at a Canadian CHC, including: primary care provider consultation visits, prescription medication (e.g., muscle relaxants, anti-inflammatories, anti-depressants, opioid and non-opioid analgesics), referral for diagnostic testing (e.g., lab work, imaging) or specialist consultation, as well as other co-interventions (e.g., visits with nurses, dieticians, social workers, or physiotherapists) as determined by their PCP. PCPs will also engage study participants in a formal effort to reduce their opioid use within the framework of each CHC's current opioid-reduction practices.

Usual Medical Care

Usual Medical Care + Chiropractic Care OTHER

Treatment sessions may include high-velocity, low-amplitude spinal manipulative therapy, as well as any or all of the following: spinal mobilization, soft-tissue massage/trigger point therapy, education and reassurance (e.g., pain management, ergonomic and activities of daily living recommendations), and home advice (e.g., icing, spinal stretching, core muscle strengthening, and cardiovascular exercises). As part of the intervention, chiropractic clinicians will engage PCPs in a collaborative effort to support opioid tapering. Consistent with current clinical practice guidelines, participants will be provided up to a maximum of 18 chiropractic visits during the active care period, although participants may continue with treatment after the 12-week period (e.g., one visit, every 2-4 weeks) to manage episodes of exacerbation/flare-up.

Usual Medical Care + Chiropractic Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Surgical Methods Centre, McMaster University: collaborator
• Michael G. DeGroote Institute for Pain Research and Care: collaborator
• Ontario Chiropractic Association: collaborator
• Alliance for Healthier Communities: collaborator
• Michael G. DeGroote National Pain Centre: collaborator
• Canadian Chiropractic Research Foundation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter C Emary, DC, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Jason W Busse, DC, PhD

  McMaster University

  STUDY DIRECTOR

Central Study Contacts

Peter C Emary, DC, PhD

CONTACT

001-519-653-1470; emaryp@mcmaster.ca

Jason W Busse, DC, PhD

CONTACT

001-905-525-9140; bussejw@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Due to the nature of the intervention, it will not be possible to blind patients, study personnel, or clinicians to treatment allocation. However, data analysts and investigators responsible for interpreting results will be blinded to treatment allocation until all data have been analyzed and interpreted.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellow, Michael G. DeGroote National Pain Centre

Model Details: Cluster-randomized, 2-arm, data analyst-blinded feasibility trial

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 7, 2023
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication

Locations

CA (1)