Impact of Chiropractic Care on Opioid Use Among Adults With Chronic Non-Cancer Spinal Pain: A Pilot Cluster Randomized Controlled Trial (ACCESS-DC Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Participant Enrolment
研究概览
简要总结
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.
详细描述
The investigators will conduct a cluster-randomized, 2-arm, data analyst-blinded feasibility RCT at four Canadian 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 26 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual Medical Care
This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care.
干预措施: Usual Medical Care (Other)
Usual Medical Care + Chiropractic Care
This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care plus chiropractic care.
干预措施: Usual Medical Care + Chiropractic Care (Other)
结局指标
主要结局
Participant Enrolment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Number of Opioid Prescriptions(Baseline, 6-, 12-, 18- and 26-week follow-up)
- Daily Prescribed Opioid Dosage(Baseline, 6-, 12-, 18- and 26-week follow-up)
- Level of Bothersomeness of Spinal Pain(Baseline, 6-, 12-, 18- and 26-week follow-up)
- Quality of Life as measured by the EuroQol 5 Domain (EQ-5D) (5 Level Version)(Baseline, 6-, 12-, 18- and 26-week follow-up)
- Risk of Higher-Dose 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 Patient Satisfaction(6-, 12-, 18- and 26-week follow-up)
研究者
Peter C Emary, DC, PhD
Postdoctoral fellow, Michael G. DeGroote National Pain Centre
McMaster University