The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study
- Conditions
- Back Pain
- Interventions
- Other: Usual Medical CareOther: Usual Medical Care + Chiropractic Care
- Registration Number
- NCT06160947
- Lead Sponsor
- McMaster University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 25
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Medical Care Usual Medical Care This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care. Usual Medical Care + Chiropractic Care Usual Medical Care + Chiropractic Care This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care plus chiropractic care.
- Primary Outcome Measures
Name Time Method 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).
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).
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).
- Secondary Outcome Measures
Name Time Method Number of Opioid Prescriptions Baseline, 6-, 12-, 18- and 26-week follow-up CHC information technology personnel will extract opioid prescription data from participants' individual electronic medical records to obtain the number and type of chronic non-cancer spinal pain-related opioid prescriptions (i.e., unique opioid fills and subsequent refills) over the entire course of follow-up, tabulated at the end of follow-up.
Daily Prescribed Opioid Dosage Baseline, 6-, 12-, 18- and 26-week follow-up CHC information technology personnel will extract opioid prescription data from participants' individual electronic medical records to obtain the dose of chronic non-cancer spinal pain-related opioid prescriptions from baseline to 26-week follow-up. Opioid dosage will be measured in milligrams (mg) of morphine equivalents daily (MED). To calculate the MED for each prescribed opioid, the investigators will multiply the quantity x the mg per unit dispensed x drug-specific conversion factors.
Level of Bothersomeness of Spinal Pain Baseline, 6-, 12-, 18- and 26-week follow-up Self-rated level of bothersomeness on a 5-point Likert scale from "Not at all bothersome" to "Extremely bothersome".
Quality of Life as measured by the EuroQol 5 Domain (EQ-5D) (5 Level Version) Baseline, 6-, 12-, 18- and 26-week follow-up Self-rated health status measured on 5 domains (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-point Likert scale from "No problems" to "Extreme problems".
Risk of Higher-Dose Opioid Prescriptions Baseline, 6-, 12-, 18- and 26-week follow-up CHC information technology personnel will extract opioid prescription data from participants' individual electronic medical records to obtain the dose of chronic non-cancer spinal pain-related opioid prescriptions. Opioid dosage will be dichotomized as either high (e.g., ≥ 90 mg) MED or low (e.g., \< 90 mg) MED at baseline and each follow-up interval. The threshold for opioid dose will be dependent on the central tendency of MED in the patient sample. A sensitivity analysis will also be conducted using a threshold of 50 mg MED.
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 The BQ consists of 7 items (i.e., pain intensity, function in activities of daily living, function in social activities, anxiety, depression levels, fear avoidance behavior, and locus of control/self-efficacy), each scored from 0-10 ("0" = no disability, "10" = complete disability) for a total of 70. To optimize interpretability, the investigators will convert mean effects to risk differences using the anchor-based minimally important difference (MID) of the BQ established for chronic low back pain patients.
Level of Patient Satisfaction 6-, 12-, 18- and 26-week follow-up Self-rated satisfaction with care on a 5-point Likert scale from "Very satisfied" to "Very dissatisfied".
Trial Locations
- Locations (1)
McMaster University
🇨🇦Hamilton, Ontario, Canada