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DOI: 10.1101/2023.05.16.23290053

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

S. A.Eucker O. Glass M. R. Knisely ...+9 S.-C. Chow
摘要
Importance: Acute musculoskeletal pain is challenging to treat in the Emergency Department (ED), a novel setting to incorporate nonpharmacologic interventions, such as acupuncture, to reduce chronic pain. Objective: Determine effectiveness of ED acupuncture for treating acute musculoskeletal pain. Design: Pragmatic two-stage adaptive randomized clinical trial over one year. Stage 1 identified whether auricular acupuncture (AA) or peripheral acupuncture (PA) was more feasible and efficacious in the ED. Stage 2 assessed effectiveness of selected ED acupuncture intervention(s) on 1-hour pain reduction compared to no acupuncture (NA). Setting: Academic tertiary-care ED. Participants: Adults with acute ([≤]7 days) musculoskeletal pain in neck, back and/or extremities. Of 911 patients screened, 491 met inclusion criteria, 247 enrolled, 11 withdrew, and 236 were randomized (68 NA, 84 AA, 84 PA). Interventions: AA places ear needles based on battlefield acupuncture. PA places needles in head, neck, and extremity sites distal to pain. Acupuncture was delivered by licensed acupuncturists. All three arms received usual care from blinded ED providers. Main Outcomes: Primary outcome: 11-point Numeric pain rating scale at 1-hour. Secondary outcomes: Satisfaction with treatment; ED opioids given. Results: Interim analysis at end of Stage 1 found both acupuncture styles similarly feasible and efficacious, so Stage 2 continued all three arms with unequal allocation (from 1:1:1 to 1:2:2 NA:AA:PA). All three arms had similar demographics (mean age 46.1 years {+/-}16.5 SD, 56.2% female, and 53.6% Black), ED baseline pain scores (AA 7.0 {+/-} 2.3, PA 7.2 {+/-} 2.3, NA 6.9 {+/-} 2.2) and pre-baseline ED administration of opioid and non-opioid analgesics. Both AA (2.1 {+/-} 2.9) and PA (1.6 {+/-} 2.0) produced significantly greater 1-hour pain reductions than NA (0.4 {+/-} 1.9). Conclusions and Relevance: Two different styles of ED acupuncture effectively reduce acute musculoskeletal pain better than usual care alone. Acupuncture is feasible, acceptable, and effective for treating pain in historically underserved populations in the emergency department setting. Clinicaltrials.gov registration: Emergency Department Acupuncture for Acute Musculoskeletal Pain Management ID#: NCT04290741; URL: https://clinicaltrials.gov/ct2/show/NCT04290741
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