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

ConditionBack Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMcMaster University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Adult patients (aged ≥ 18 years)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Usual Medical Care
Other intervention
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
Other intervention
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.

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: Usual Medical CareActive comparator 1 intervention

Group B: Usual Medical Care + Chiropractic CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

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).

Time frame