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

Study Overview
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Brief Summary
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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
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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 8 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, other health care utilization, work status, quality of life, and adverse events at 2, 4, 8, and 12 weeks from allocation.

Official Title
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Impact of Chiropractic Care on Opioid Use Among Adults With Chronic Non-Cancer Spinal Pain: A Pilot Cluster Randomized Controlled Trial

Conditions
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Back Pain

Intervention / Treatment
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* Other: Usual Medical Care
* Other: Usual Medical Care + Chiropractic Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Incarceration, or planned incarceration The participant is or may be enrolled in a competing trial Other reason to exclude the participant, as specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-randomized, 2-arm, data analyst-blinded feasibility trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Medical Care<br>This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care. | Other: Usual Medical Care<br>* 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 an Ontario 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 required. All participants will also receive opioid-reduction encouragement as per each CHC's current practices. Due to socioeconomic disadvantages, most CHC patients will be unlikely to access private health care services, including chiropractic care, elsewhere. Nevertheless, the investigators will collect data on other health care utilization and conduct all analyses using an intention-to-treat principle.<br>|
| Experimental: Usual Medical Care + Chiropractic Care<br>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<br>* 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, and core muscle strengthening exercises). Primary care providers will also engage participants in a formal collaborative effort with the chiropractic clinicians to reduce opioid use. Consistent with current clinical practice guidelines, participants will be provided up to a maximum of 12 chiropractic visits during the active care period, although participants may continue with treatment after the 8-week period (e.g., one visit, every 2-4 weeks) to manage further episodes of exacerbation/flare-up. Aside from the experimental intervention, participants in both study groups will follow the same protocol to minimize non-specific effects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Recruitment | Recruitment rate of participants, measured as the number of eligible participants recruited (i.e., consented and enrolled) per week at each center. | From start of enrollment up to 26 weeks (or study end) | 
| Feasibility of Retention | Participant retention, measured as the percentage of participants successfully followed for the 12-week study period. The investigators will consider the pilot successful if at least 80% follow-up is achieved at 12 weeks for the primary definitive trial outcomes (i.e., total prescribed opioid usage, and levels of pain intensity and function as measured by the Bournemouth Questionnaire). | Assessed at 38 weeks (or 12 weeks from study end) | 
| Intervention Acceptability | Participant compliance with appointment schedules, measured as the percentage of scheduled appointments attended. The investigators will consider 70% attendance to signify feasibility. | From enrollment to end of active treatment at 8 weeks | 
| Feasibility of Data Completion | Measured as the percentage of items completed on patient-reported outcome questionnaires. The investigators will claim feasibility with 80% or greater completion of the Bournemouth and EuroQol 5 Domain (5 level version) questionnaires. | Baseline, 2-, 4-, 8- and 12-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Prescribed Opioid Usage | Study personnel will extract opioid prescription data from participants' individual electronic medical records to obtain the number of chronic non-cancer spinal pain-related opioid prescriptions (i.e., unique opioid fills and subsequent refills) from baseline to 12-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. In addition, the investigators will dichotomize opioid dosage 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. The investigators will also conduct a sensitivity analysis using a threshold of 50 mg MED. | Baseline, 2-, 4-, 8- and 12-week follow-up | 
| Level of Pain Intensity, and Physical and Emotional Functioning as measured by the Bournemouth Questionnaire (BQ) | 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. | Baseline, 2-, 4-, 8- and 12-week follow-up | 
| Level of Bothersomeness of Spinal Pain | Self-rated level of bothersomeness on a 5-point Likert scale from Not at all bothersome to Extremely bothersome. | Baseline, 2-, 4-, 8- and 12-week follow-up | 
| Level of Patient Satisfaction | Self-rated satisfaction with care on a 5-point Likert scale from Very satisfied to Very dissatisfied. | 2-, 4-, 8- and 12-week follow-up | 
| Quality of Life as measured by the EuroQol 5 Domain (EQ-5D) (5 Level Version) | (a) 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; and (b) Self-rated health status measured on a visual analog scale from 0-100 (0 = worst health imaginable, 100 = best health imaginable). The investigators will convert mean effects to risk differences using the anchor-based MID of the EQ-5D established for chronic low back pain patients to optimize interpretability. | Baseline, 2-, 4-, 8- and 12-week follow-up | 
| Other Health Care Utilization at Baseline | Participants will be asked: Have you sought help from any other practitioner, such as your GP [general practitioner] or another healthcare professional, for this present episode of your painful complaint? If yes, please specify: (check all that apply) (GP; Nurse practitioner; Nurse; Dietician; Social worker; Community health worker; Physiotherapist; Other, please specify: __________________). | Baseline | 
| Other Health Care Utilization at Follow-Up | Participants will be asked: Since starting treatment at this clinic, have you sought help from any other practitioner, such as your GP or another healthcare professional, for your complaint? If yes, please specify: (check all that apply) (GP; Nurse practitioner; Nurse; Dietician; Social worker; Community health worker; Physiotherapist; Other, please specify: __________________). | 2-, 4-, 8- and 12-week follow-up | 
| Work Status | Participants will be asked: (a) Are you currently employed? If yes, what is your occupation: __________________. If no, are you: (please check only one answer) (Retired; Home-maker; Student; Home on doctor's advice; Unemployed; Other, please specify: __________________); (b) Are you receiving any disability benefits because of your spine pain? (please check only one answer) (Yes; No, but it's possible that I will; No, but it's likely I will; No, and it's very unlikely I will); and (c) Are you currently involved with a lawyer (or ongoing litigation) as a result of your spine pain? (please check only one answer) (Yes; No, but it's possible that I will; No, but it's likely I will; No, and it's very unlikely I will). | Baseline and 12-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical trials, randomized, Feasibility study, Analgesics, opioid, Chiropractic