An Adaptive Pragmatic Randomized Controlled Trial of Emergency Department Acupuncture for Acute Musculoskeletal Pain Management - 23/05/24
, Oliver Glass, PhD, MHSc b, Mitchell R. Knisely, PhD, RN c, Amy O’Regan, MPH d, Alexander Gordee, MA e, f, Cindy Li, BS a, Christopher L. Klasson, BA g, Olivia TumSuden, BS h, Alena Pauley, MSc a, Harrison J. Chen, BS a, Anna Tupetz, DPT, MSc a, c, Catherine A. Staton, MD, MSc a, i, Maragatha Kuchibhatla, PhD e, j, Shein-Chung Chow, PhD eon behalf of the
Duke Emergency Department Acupuncture Research team
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Abstract |
Study objective |
Acute musculoskeletal pain in emergency department (ED) patients is frequently severe and challenging to treat with medications alone. The purpose of this study was to determine the feasibility, acceptability, and effectiveness of adding ED acupuncture to treat acute episodes of musculoskeletal pain in the neck, back, and extremities.
Methods |
In this pragmatic 2-stage adaptive open-label randomized clinical trial, Stage 1 identified whether auricular acupuncture (AA; based on the battlefield acupuncture protocol) or peripheral acupuncture (PA; needles in head, neck, and extremities only), when added to usual care was more feasible, acceptable, and efficacious in the ED. Stage 2 assessed effectiveness of the selected acupuncture intervention(s) on pain reduction compared to usual care only (UC). Licensed acupuncturists delivered AA and PA. They saw and evaluated but did not deliver acupuncture to the UC group as an attention control. All participants received UC from blinded ED providers. Primary outcome was 1-hour change in 11-point pain numeric rating scale.
Results |
Stage 1 interim analysis found both acupuncture styles similar, so Stage 2 continued all 3 treatment arms. Among 236 participants randomized, demographics and baseline pain were comparable across groups. When compared to UC alone, reduction in pain was 1.6 (95% confidence interval [CI]: 0.7 to 2.6) points greater for AA+UC and 1.2 (95% CI: 0.3 to 2.1) points greater for PA+UC patients. Participants in both treatment arms reported high satisfaction with acupuncture.
Conclusion |
ED acupuncture is feasible and acceptable and can reduce acute musculoskeletal pain better than UC alone.
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| Please see page XX for the Editor’s Capsule Summary of this article. |
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| Supervising editor: Steven M. Green, MD. Specific detailed information about possible conflict of interest for individual editors is available at editors. |
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| Author contributions: SAE is principal investigator of the study, drafted the manuscript, and is responsible for the overall study and final decisions on the trial design and manuscript. SCC, OG, CAS, MRK, and AT participated in the design of the study and revising the manuscript. MK and AG were responsible for the statistical design and analysis of the study and revising the manuscript. AO, CL, CLK, OT, AP, and HC were involved as clinical research coordinators in revising the protocol and manuscript. All authors approved the final manuscript. |
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| Data sharing statement: Data are not currently available due to ongoing additional analyses. Data will be available in the future on request. |
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| Authorship: All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
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| Funding and support: By Annals’ policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). This project is supported by The Substance Abuse and Mental Health Services Administration (SAMHSA) Emergency Department Alternatives to Opioids Demonstration Program (ED-ALT) grant number H79TI083109. This project is included as part of the Duke School of Medicine Opioid Collaboratory, which is administered through the Duke Department of Population Health Sciences and supported by grant funding from the Duke Endowment. The Collaboratory’s mission is to save lives and reduce the harmful effects of opioids in North Carolina through the development, implementation, and evaluation of system-level interventions. All authors declare no conflicts of interest. |
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| Trial registration number: Emergency Department Acupuncture for Acute Musculoskeletal Pain Management. ID#: NCT04290741; URL: NCT04290741. |
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