1/2: Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Phase 3 Study (ACUITY 2)

About This Grant

Over 70% of Emergency Department (ED) visits involve acute pain that continues to be a challenge to manage. Musculoskeletal pain (back, neck, and limb) and non musculoskeletal pain (abdominal, flank) are equally prevalent in the ED. Low-risk and effective ways to improve pain relief (e.g. acupuncture) are needed in the ED. Prior randomized controlled trials (RCTs) of acupuncture in the ED compared to usual care were promising, but there are numerous gaps. ACUITY was our NCCIH-funded R01 multi-center, feasibility RCT that included 3 centers. ED acute pain patients and reporting pain >4 on the 0-10 numeric rating scale (NRS) were randomized to either Acupuncture or Usual Care. NCCIH did not allow any statistical significance testing, but pain intensity decreased more after acupuncture (n=76) than usual care (n=75). Recruitment and retention were feasible, fidelity to the responsive acupuncture intervention protocol was high (98.1%), and 75% of ED providers and 88% of those receiving acupuncture were “satisfied or very satisfied.” Thus, our team has the necessary evidence and expertise to conduct a multi-center, Phase 3 RCT of acupuncture versus usual care. Our aims for the proposed planning UG3 are to: Aim 1: Finalize the infrastructure required to implement ACUITY2 in 5 EDs affiliated with BraveNet clinics. Aim 2: Conduct a 3-month pilot study (15 pts per center) to assess refinements to the responsive acupuncture intervention documentation and other updates in REDCap; and Aim 3: Refine and prepare to implement the protocol in a rigorous, multi-cite RCT. The target population will be 660 adults presenting to the ED with acute pain ≥4 on a 0-10-point NRS. The sample size includes expected attrition rate of 10% with power of 90%. To allow for simultaneous examination of two hypothesis we will enroll: (1) 330 patients with musculoskeletal (limb, back, or neck pain) who will be equally randomized to acupuncture or usual care and (2) 330 patients with non-musculoskeletal (abdominal or flank pain) to be randomized in a similar fashion. Our specific aims for the proposed UH3 are to conduct a Phase 3 RCT. Aim 1: Test whether the between group difference in pain intensity (0-10 NRS) from Pre to Post treatment (~60 min) is >1.3 units for those receiving Acupuncture compared to Usual Care in a (Aim 1a) musculoskeletal cohort and (Aim 1b) non- musculoskeletal cohort. Aim 2: Test whether the between group difference in pain intensity from Pre to 1-week is >1.3 NRS units in Acupuncture versus Usual Care in a (Aim 2a) musculoskeletal cohort and (Aim 2b) non- musculoskeletal cohort. Aim 3: (Exploratory): Test if acupuncture reduces narcotic pain medications utilized in the ED, and/or provision of a narcotic prescription at ED discharge compared to Usual Care in a (Aim 3a) musculoskeletal cohort and (Aim 3b) non-musculoskeletal cohort. Successful conduct of ACUITY2 would provide evidence to support inclusion of acupuncture in EDs across the US for non-pharmacological pain relief and ideally reduced opioid use.