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

Condition(s) studied

Investigational drug(s) / intervention(s)

Usual Medical Care: 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 + Chiropractic Care: 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.

Study 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

Primary outcome measure(s)

• Participant Enrolment — From start of enrollment up to 26 weeks (or study end)
  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).
• Treatment Allocation — Baseline, 6-, 12-, 18- and 26-week follow-up
  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).
• Refinement of Data Collection Methods — Baseline, 6-, 12-, 18- and 26-week follow-up
  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).
• Compliance with the Protocol — Baseline, 6-, 12-, 18- and 26-week follow-up
  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).

Trial sites (1)

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