Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial

Abstract

IntroductionChronic musculoskeletal pain causes a significant burden on health and quality of life and may result from inadequate treatment of acute musculoskeletal pain. The emergency department (ED) represents a novel setting in which to test non-pharmacological interventions early in the pain trajectory to prevent the transition from acute to chronic pain. Acupuncture is increasingly recognised as a safe, affordable and effective treatment for pain and anxiety in the clinic setting, but it has yet to be established as a primary treatment option in the ED.Methods and analysisThis pragmatic clinical trial uses a two-stage adaptive randomised design to determine the feasibility, acceptability and effectiveness of acupuncture initiated in the ED and continued in outpatient clinic for treating acute musculoskeletal pain. The objective of the first (treatment selection) stage is to determine the more effective style of ED-based acupuncture, auricular acupuncture or peripheral acupuncture, as compared with no acupuncture. All arms will receive usual care at the discretion of the ED provider blinded to treatment arm. The objective of the second (effectiveness confirmation) stage is to confirm the impact of the selected acupuncture arm on pain reduction. An interim analysis is planned at the end of stage 1 based on probability of being the best treatment, after which adaptations will be considered including dropping the less effective arm, sample size re-estimation and unequal treatment allocation ratio (eg, 1:2) for stage 2. Acupuncture treatments will be delivered by licensed acupuncturists in the ED and twice weekly for 1 month afterward in an outpatient clinic.Ethics and disseminationThis study has been reviewed and approved by the Duke University Health System Institutional Review Board. Informed consent will be obtained from all participants. Results will be disseminated through peer-review publications and public and conference presentations.Trial registration numberNCT04290741.

An Adaptive Pragmatic Randomized Controlled Trial of Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

“…A sample size of 220 total subjects for Phase 1 was calculated using a minimally clinically significant difference in pain score of 1.3, 90% power and α = 5%, based on a 2-stage adaptive design with 90 subjects allocated 1:1:1 to three arms (AA+UC, PA+UC, UC) in Stage 1, and the remaining 130 subjects to two arms assuming 1:2 control:treatment allocation for Stage 2, 29,40,41 adjusted for one planned interim analysis using O’Brien-Fleming type of alpha spending function 28 and a 10% drop rate. 27…”

“…A sample size of 220 total subjects for Phase 1 was calculated using a minimally clinically significant difference in pain score of 1.3, 90% power and α = 5%, based on a 2-stage adaptive design with 90 subjects allocated 1:1:1 to three arms (AA+UC, PA+UC, UC) in Stage 1, and the remaining 130 subjects to two arms assuming 1:2 control:treatment allocation for Stage 2, 29,40,41 adjusted for one planned interim analysis using O'Brien-Fleming type of alpha spending function 28 and a 10% drop rate. 27 Primary analysis for the primary end-point was based on intention-to-treat (ITT) including all randomized subjects combined from both stages with at least one follow-up evaluation. For all outcomes, complete case analysis was conducted by excluding subjects missing the one-hour outcome.…”

“…The detailed study methods were previously published. 27 In brief, the first stage objective was to identify which style of ED-based acupuncture, AA or PA, is more feasible, acceptable and potentially more efficacious in ED patients with acute musculoskeletal pain. The second stage objective was to determine the effectiveness of the selected acupuncture style compared to attention control receiving usual care only (UC) on pain reduction.…”

“…Trained clinical research coordinators (CRCs) performed all patient screening, recruitment, informed e-consent, and enrollment procedures. Licensed acupuncturists trained in traditional Chinese medicine explained and delivered acupuncture treatments 27 . A convenience sample of patients was enrolled during 8-hour periods, typically occurring sometime between 8am-8pm, Monday-Friday.…”

“…Two different acupuncture interventions (AA and PA) were performed by licensed acupuncturists while in the ED, and are described in detail elsewhere. 27 In brief, (1) Auricular acupuncture (AA) placed press needles in up to 5 bilateral ear sites corresponding to the Battlefield Acupuncture protocol. 17,18 (2) Peripheral acupuncture (PA) placed needles in select head, neck, and extremity sites based on acupuncturist clinical discretion.…”