AcupunctureACUITYNCT04880733

Acupuncture in the Emergency Department for Pain Management

A study testing Acupuncture for pain management in people with Acupuncture and Pain Management, run by Case Western Reserve University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acupuncture, Pain Management, Emergency Department
What is being tested?: Acupuncture for pain management
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 290 participants
Where: 4 sitesUnited States
Study dates: 3 May 2021to 31 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients ≥18 years of age
Ability to communicate in English.
Level 3, 4, 5 on triage rate scale
Presentation with acute non-emergent (musculoskeletal, back, pelvic, non-cardiac chest, abdominal, flank or head) pain ≥4 on a 0-10-point NRS due to non-penetrating injury.

Who cannot join

Fever exceeding 100° F
Presenting with a chief complaint of a psychological / psychiatric concern
Presenting with chief complaint of Migraine
Patient arriving via ambulance or skipping triage
Current Pregnancy
Self-reported opioid medication taken orally within 4 hours

Show all 9Show fewer

Presenting with chief complaint of Joint Dislocation
Presenting with chief complaint of Bone Fracture
Confirmed or suspected COVID-19

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University Hospitals/Case Western Reserve University- Cleveland Medical Center
Cleveland, Ohio, 44106
University of California San Diego
La Jolla, California, 92093
Vandebilt University Medical Center
Nashville, Tennessee, 37232
Einstein School of Medicine
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study

Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

Read the detailed description

The goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will include the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), the investigators will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. Prior to the start of the RCT at all sites, study investigator meetings will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), the investigators will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Study outcomes include responsive manualization of acupuncture intervention, recruitment, retention, patient adoption, patient acceptability, and provider acceptability. Measures will be collected including pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

Conditions: Acupuncture, Pain Management, Emergency Department, Acute Pain
Being tested: Acupuncture for pain management, Usual care for pain management
Medical subject headings: Agnosia, Emergencies, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acupuncture for pain managementProcedure or surgery
A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.
Usual care for pain managementOther
Patient will receive usual care for pain management.

Study groups in NCT04880733
Study group	Role	What they receive
Acupuncture	Experimental	This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. Receives: Procedure: Acupuncture for pain management; Other: Usual care for pain management
Usual Care	Active comparator	This arm will receive usual care for pain management. Receives: Other: Usual care for pain management

What is being measured

The primary outcome is the main question the study is designed to answer.

Successful Recruitment of Participants Into the Study.
The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.
Measured: At Enrollment

Secondary outcomes (10)

Percentage of Participants Retained in the Study at Post Treatment
Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at post-treatment. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.
Measured: At post treatment (45-60 minutes)
Percentage of Patients Retained at 1-week Follow up
Retained patients will be defined as those providing patient reported outcomes scores at 1 week. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.
Measured: One-week after the participant was discharged from the ED
Patient Satisfaction Question 1 at Post-treatment
Question 1: "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Measured: At post-treatment (45-60 minutes after baseline)
Patient Satisfaction Question 2 at Post-treatment
"Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Measured: At post-treatment (45-60 minutes after baseline)
Patient Satisfaction Question 1 at 1-Week
"How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Measured: One week after participant was discharged from the ED
Patient Satisfaction Question 2 at 1 Week
"Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).
Measured: One week after participant was discharged from the ED
Provider Satisfaction Question1
"Do you view acupuncture in general as an appropriate intervention for the ED setting?" on a 5 point scale (0: Very inappropriate; 1: Inappropriate; 2: Neutral; 4: Appropriate; 4: Very appropriate). Higher scores are better.
Measured: After enrollment at the provider's site completed (~6 months after first enrollee).
Provider Satisfaction Question 2
"Do you view acupuncture in general as helpful in managing patient pain in the ED?" on a 5 point scale (0: Not at all helpful; 1: Somewhat Unhelpful; 2: Neutral; 3: Somewhat Helpful; 4: Very Helpful). Higher scores are better.
Measured: After enrollment at the provider's site completed (~6 months after first enrollee).
Provider Satisfaction Question 3
"How satisfied are you with the way that the acupuncture intervention was implemented in your setting" on the 5-point Likert scale (4-Very Satisfied; 3-Satisfied; 2-Neither Satisfied nor Dissatisfied; 1-Dissatisfied; 0-Very Dissatisfied). Higher scores are better
Measured: After enrollment at the provider's site completed (~6 months after first enrollee).
Provider Satisfaction Que4
"Did the ACUITY project impose a burden on ED staff in your setting?" on the 4-point Likert scale (0-Not at all a burden; 1-Somewhat of a burden; 2-Moderate burden 3-Extreme burden). Lower scores are better
Measured: After enrollment at the provider's site completed (~6 months after first enrollee).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 202131 Aug 2025

First posted11 May 2021
Study start3 May 2021
Primary completion24 Sep 2022
Study completion31 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for AcupunctureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04880733
Sponsor's protocol ID: R01AT010598-01A1
Acronym: ACUITY
Status last verified: Dec 2025
First submitted: 30 Apr 2021
Last updated: 5 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Dusek JA, Kallenberg GA, Storrow AB, Hughes RM, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, Faryar KA, Dyer NL, Barton BA, McKee MD. Acupuncture in the emergency department (ACUITY): Results from a BraveNet multi-center feasibility randomized controlled trial. Integr Med Res. 2024 Dec;13(4):101095. doi: 10.1016/j.imr.2024.101095. Epub 2024 Oct 21.
PubMed 39640074
Nielsen A, Dyer NL, Lechuga C, McKee MD, Dusek JA. Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines. Integr Med Res. 2024 Jun;13(2):101048. doi: 10.1016/j.imr.2024.101048. Epub 2024 May 10.
PubMed 38841077
Dusek JA, Kallenberg GA, Hughes RM, Storrow AB, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, McKee MD. Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study. Medicine (Baltimore). 2022 Mar 4;101(9):e28961. doi: 10.1097/MD.0000000000028961.
PubMed 35244059
Nielsen A, Olson J, Quesada M, Zhu C, Raskin E, Vang B, Painovich J, Scott M, Xiong VJ, Dusek JA. Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process. Acupunct Med. 2022 Aug;40(4):339-346. doi: 10.1177/09645284221076507. Epub 2022 Mar 1.
PubMed 35229658
Dyer NL, Surdam J, Dusek JA. A Systematic Review of Practiced-Based Research of Complementary and Integrative Health Therapies as Provided for Pain Management in Clinical Settings: Recommendations for the Future and a Call to Action. Pain Med. 2022 Jan 3;23(1):189-210. doi: 10.1093/pm/pnab151.
PubMed 34009391

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study
ClinicalTrials.gov ID: NCT04880733
Acronym / sponsor ID: ACUITY / R01AT010598-01A1
Conditions: Acupuncture, Pain Management, Emergency Department, Acute Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Case Western Reserve UniversityUniversity, hospital or other
Collaborators: Vanderbilt University Medical Center, University of California, San Diego, Albert Einstein College of Medicine, University of Massachusetts, Worcester
Study start: 3 May 2021 (actual)
Primary completion: 24 Sep 2022 (actual)
Study completion: 31 Aug 2025 (actual)
First posted: 11 May 2021 (actual)
Results: Posted 20 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Acupuncture	Experimental	Procedure: Acupuncture for pain management, Other: Usual care for pain managementThis arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.
Usual Care	Active comparator	Other: Usual care for pain managementThis arm will receive usual care for pain management.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients ≥18 years of age
Ability to communicate in English.
Level 3, 4, 5 on triage rate scale
Presentation with acute non-emergent (musculoskeletal, back, pelvic, non-cardiac chest, abdominal, flank or head) pain ≥4 on a 0-10-point NRS due to non-penetrating injury.

Key exclusion criteria (9 listed)

Fever exceeding 100° F
Presenting with a chief complaint of a psychological / psychiatric concern
Presenting with chief complaint of Migraine
Patient arriving via ambulance or skipping triage
Current Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acupuncture for pain managementA manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.	Procedure or surgery	Acupuncture
Usual care for pain managementPatient will receive usual care for pain management.	Other	Acupuncture, Usual Care

Primary outcome

Successful Recruitment of Participants Into the Study.
Time frame: At Enrollment
The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.

10 secondary outcomes

Percentage of Participants Retained in the Study at Post Treatment
Time frame: At post treatment (45-60 minutes)
Percentage of Patients Retained at 1-week Follow up
Time frame: One-week after the participant was discharged from the ED
Patient Satisfaction Question 1 at Post-treatment
Time frame: At post-treatment (45-60 minutes after baseline)
Patient Satisfaction Question 2 at Post-treatment
Time frame: At post-treatment (45-60 minutes after baseline)
Patient Satisfaction Question 1 at 1-Week
Time frame: One week after participant was discharged from the ED
Patient Satisfaction Question 2 at 1 Week
Time frame: One week after participant was discharged from the ED
Provider Satisfaction Question1
Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).
Provider Satisfaction Question 2
Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).
Provider Satisfaction Question 3
Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).
Provider Satisfaction Que4
Time frame: After enrollment at the provider's site completed (~6 months after first enrollee).

Results and safety

Results posted to the registry on 20 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acupuncture	83	76
Usual Care	82	75
ED Staff/Providers	0	0

Primary outcome: Successful Recruitment of Participants Into the Study.

Time frame: At Enrollment. Number. Unit: Percentage of participants enrolled

Measure	Total Approached n = 632	University Hospitals/Case Western n = 220	VUMC n = 300	UCSD n = 112
Value	26.1	27.7	16.3	49.1

Population analysed: Patients who were eligible AND approached.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Any adverse event from baseline to 4 weeks for the Acupuncture and Usual Care Arms, approximately 6 months for the ED Staff/Providers Arm. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acupuncture	1 of 83 (1.2%)	0 of 83 (0%)	1 of 83
Usual Care	1 of 82 (1.2%)	0 of 82 (0%)	0 of 82
ED Staff/Providers	0 of 125 (0%)	0 of 125 (0%)	0 of 125

Limitations and caveats (from the sponsor): It should be noted that recruitment was conducted during the COVID-19 pandemic.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39640074Dusek JA, Kallenberg GA, Storrow AB, Hughes RM, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, Faryar KA, Dyer NL, Barton BA, McKee MD. Acupuncture in the emergency department (ACUITY): Results from a BraveNet multi-center feasibility randomized controlled trial. Integr Med Res. 2024 Dec;13(4):101095. doi: 10.1016/j.imr.2024.101095. Epub 2024 Oct 21.
Derived from this study: PubMed 38841077Nielsen A, Dyer NL, Lechuga C, McKee MD, Dusek JA. Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines. Integr Med Res. 2024 Jun;13(2):101048. doi: 10.1016/j.imr.2024.101048. Epub 2024 May 10.
Derived from this study: PubMed 35244059Dusek JA, Kallenberg GA, Hughes RM, Storrow AB, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, McKee MD. Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study. Medicine (Baltimore). 2022 Mar 4;101(9):e28961. doi: 10.1097/MD.0000000000028961.
Derived from this study: PubMed 35229658Nielsen A, Olson J, Quesada M, Zhu C, Raskin E, Vang B, Painovich J, Scott M, Xiong VJ, Dusek JA. Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process. Acupunct Med. 2022 Aug;40(4):339-346. doi: 10.1177/09645284221076507. Epub 2022 Mar 1.
Derived from this study: PubMed 34009391Dyer NL, Surdam J, Dusek JA. A Systematic Review of Practiced-Based Research of Complementary and Integrative Health Therapies as Provided for Pain Management in Clinical Settings: Recommendations for the Future and a Call to Action. Pain Med. 2022 Jan 3;23(1):189-210. doi: 10.1093/pm/pnab151.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffery A Dusek, PhD principal investigator

University California-Irvine

M. Diane McKee, MD principal investigator

University of Massachusetts, Worcester

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture for pain management in people with Acupuncture and Pain Management, run by Case Western Reserve University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Recruitment of Participants Into the Study. (time frame: At Enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04880733, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.