1/2: acupuncture in the emergency department for pain management: a bravenet multi-center phase 3 study (acuity 2) - over 70% of emergency department (ED) visits involve acute pain that continues to…

The National Center for Complementary and Integrative Health awarded University of California Irvine a cooperative agreement for $1,214,743 on August 15, 2026, under the Research and Training in Complementary and Integrative Health program (CFDA 93.213).

The award funds planning and pilot activities for ACUITY 2, a multi-center Phase 3 randomized controlled trial of acupuncture versus usual care for acute pain management in emergency departments. The planning phase includes three aims: finalizing infrastructure to implement the trial across five emergency departments affiliated with BRAVENET clinics; conducting a three-month pilot study with 15 patients per center to refine the responsive acupuncture intervention documentation and REDCap data collection systems; and preparing the protocol for rigorous multi-site implementation. The proposed Phase 3 trial will enroll 660 adults presenting to participating emergency departments with acute pain rated 4 or higher on a 0–10 numeric rating scale, including 330 patients with musculoskeletal pain and 330 with non-musculoskeletal pain, powered at 90 percent with an expected 10 percent attrition rate.

The award builds on a prior NCCIH-funded feasibility study (ACUITY) conducted across three centers, which demonstrated that pain intensity decreased more after acupuncture than usual care, achieved high protocol fidelity (98.1 percent), and showed high provider and patient satisfaction (75 percent and 88 percent satisfied or very satisfied, respectively).

Performance occurs in Irvine, California, with a period of performance through July 31, 2027.

1/2: acupuncture in the emergency department for pain management: a bravenet multi-center phase 3 study (acuity 2) - 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.