Trial Outcomes & Findings for Acupuncture in the Emergency Department for Pain Management (NCT NCT04880733)

NCT ID: NCT04880733

Last Updated: 2026-01-05

Results Overview

The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

290 participants

Primary outcome timeframe

At Enrollment

Results posted on

2026-01-05

Participant Flow

Recruitment period: May 3, 2021 - September 24, 2022 from three Emergency Departments

At the moment of consent,165 patients were randomized to group. However, 14 (7 per group) did not provide outcomes as detailed below. Complete participants were 151 at Post-Treatment. A sample of ED providers at the sites answered 2 questions on the appropriateness and helpfulness of acupuncture being provided in the Emergency Department. Individuals with direct exposure to ACUITY answered 2 more questions on satisfaction and burden of conducting ACUITY in their ED.

Participant milestones

Participant milestones
Measure
Acupuncture
This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. Acupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room. Usual care for pain management: Patient will receive usual care for pain management.
Usual Care
This arm will receive usual care for pain management. Usual care for pain management: Patient will receive usual care for pain management.
ED Staff/Providers
These were ED staff or providers who answered questions after their site had finished study recruitment.
Participants in the RCT (Overall Study)
STARTED
83
82
0
Participants in the RCT (Overall Study)
Received Acupuncture
79
0
0
Participants in the RCT (Overall Study)
Received Usual Care
0
82
0
Participants in the RCT (Overall Study)
COMPLETED
76
75
0
Participants in the RCT (Overall Study)
NOT COMPLETED
7
7
0
ED Staff/Providers 6 Month Assessment
STARTED
0
0
125
ED Staff/Providers 6 Month Assessment
Completed Question 1
0
0
125
ED Staff/Providers 6 Month Assessment
Completed Question 2
0
0
124
ED Staff/Providers 6 Month Assessment
Completed Question 3
0
0
32
ED Staff/Providers 6 Month Assessment
Completed Question 4
0
0
32
ED Staff/Providers 6 Month Assessment
COMPLETED
0
0
124
ED Staff/Providers 6 Month Assessment
NOT COMPLETED
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Acupuncture
This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. Acupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room. Usual care for pain management: Patient will receive usual care for pain management.
Usual Care
This arm will receive usual care for pain management. Usual care for pain management: Patient will receive usual care for pain management.
ED Staff/Providers
These were ED staff or providers who answered questions after their site had finished study recruitment.
Participants in the RCT (Overall Study)
Data collection issue
3
5
0
Participants in the RCT (Overall Study)
Withdrawal by Subject
3
1
0
Participants in the RCT (Overall Study)
Delay due to ED imaging
1
0
0
Participants in the RCT (Overall Study)
Early discharge
0
1
0
ED Staff/Providers 6 Month Assessment
Skipped question 2
0
0
1

Baseline Characteristics

Ethnicity data not collected for the ED Staff/Providers Arm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Acupuncture
n=76 Participants
This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. Acupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room. Usual care for pain management: Patient will receive usual care for pain management.
Usual Care
n=75 Participants
This arm will receive usual care for pain management. Usual care for pain management: Patient will receive usual care for pain management.
ED Staff/Providers
n=125 Participants
ED Staff and Providers were asked complete 2 questions about their perceptions of acupuncture in the ED. If the ED staff or providers had direct contact with the ACUITY study in their ED, then they were asked to complete 2 additional questions inquiring about how ACUITY may have impacted the ED.
Total
n=276 Participants
Total of all reporting groups
Age, Continuous
44.9 years
STANDARD_DEVIATION 16.9 • n=76 Participants
43.9 years
STANDARD_DEVIATION 17.4 • n=75 Participants
37.6 years
STANDARD_DEVIATION 9.35 • n=125 Participants
44.4 years
STANDARD_DEVIATION 17.1 • n=276 Participants
Sex: Female, Male
Female
39 Participants
n=76 Participants
47 Participants
n=75 Participants
65 Participants
n=125 Participants
151 Participants
n=276 Participants
Sex: Female, Male
Male
37 Participants
n=76 Participants
28 Participants
n=75 Participants
60 Participants
n=125 Participants
125 Participants
n=276 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
n=76 Participants • Ethnicity data not collected for the ED Staff/Providers Arm
11 Participants
n=75 Participants • Ethnicity data not collected for the ED Staff/Providers Arm
0 Participants
Ethnicity data not collected for the ED Staff/Providers Arm
20 Participants
n=151 Participants • Ethnicity data not collected for the ED Staff/Providers Arm
Ethnicity (NIH/OMB)
Not Hispanic or Latino
67 Participants
n=76 Participants • Ethnicity data not collected for the ED Staff/Providers Arm
64 Participants
n=75 Participants • Ethnicity data not collected for the ED Staff/Providers Arm
0 Participants
Ethnicity data not collected for the ED Staff/Providers Arm
131 Participants
n=151 Participants • Ethnicity data not collected for the ED Staff/Providers Arm
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=76 Participants • Ethnicity data not collected for the ED Staff/Providers Arm
0 Participants
n=75 Participants • Ethnicity data not collected for the ED Staff/Providers Arm
0 Participants
Ethnicity data not collected for the ED Staff/Providers Arm
0 Participants
n=151 Participants • Ethnicity data not collected for the ED Staff/Providers Arm
Race/Ethnicity, Customized
White
37 individuals
n=76 Participants • Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm
28 individuals
n=75 Participants • Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm
65 individuals
n=151 Participants • Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm
Race/Ethnicity, Customized
Black/AA
34 individuals
n=76 Participants • Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm
33 individuals
n=75 Participants • Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm
67 individuals
n=151 Participants • Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm
Race/Ethnicity, Customized
Other
5 individuals
n=76 Participants • Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm
14 individuals
n=75 Participants • Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm
19 individuals
n=151 Participants • Race/Ethnicity, Customized data not collected for the ED Staff/Providers Arm
Education
No high school diploma
1 Participants
n=76 Participants • Education data not collected for the ED Staff/Providers Arm
4 Participants
n=75 Participants • Education data not collected for the ED Staff/Providers Arm
5 Participants
n=151 Participants • Education data not collected for the ED Staff/Providers Arm
Education
High school or equivalent
26 Participants
n=76 Participants • Education data not collected for the ED Staff/Providers Arm
23 Participants
n=75 Participants • Education data not collected for the ED Staff/Providers Arm
49 Participants
n=151 Participants • Education data not collected for the ED Staff/Providers Arm
Education
Some college
26 Participants
n=76 Participants • Education data not collected for the ED Staff/Providers Arm
28 Participants
n=75 Participants • Education data not collected for the ED Staff/Providers Arm
54 Participants
n=151 Participants • Education data not collected for the ED Staff/Providers Arm
Education
College degree
17 Participants
n=76 Participants • Education data not collected for the ED Staff/Providers Arm
17 Participants
n=75 Participants • Education data not collected for the ED Staff/Providers Arm
34 Participants
n=151 Participants • Education data not collected for the ED Staff/Providers Arm
Education
Graduate or professional degree
5 Participants
n=76 Participants • Education data not collected for the ED Staff/Providers Arm
3 Participants
n=75 Participants • Education data not collected for the ED Staff/Providers Arm
8 Participants
n=151 Participants • Education data not collected for the ED Staff/Providers Arm
Education
Decline to answer
1 Participants
n=76 Participants • Education data not collected for the ED Staff/Providers Arm
0 Participants
n=75 Participants • Education data not collected for the ED Staff/Providers Arm
1 Participants
n=151 Participants • Education data not collected for the ED Staff/Providers Arm
Income
Less than $20,000
22 Participants
n=76 Participants • Income data not collected for the ED Staff/Providers Arm
27 Participants
n=75 Participants • Income data not collected for the ED Staff/Providers Arm
49 Participants
n=151 Participants • Income data not collected for the ED Staff/Providers Arm
Income
$20,000 - $50,000
21 Participants
n=76 Participants • Income data not collected for the ED Staff/Providers Arm
23 Participants
n=75 Participants • Income data not collected for the ED Staff/Providers Arm
44 Participants
n=151 Participants • Income data not collected for the ED Staff/Providers Arm
Income
$50,001 to $100,000
9 Participants
n=76 Participants • Income data not collected for the ED Staff/Providers Arm
6 Participants
n=75 Participants • Income data not collected for the ED Staff/Providers Arm
15 Participants
n=151 Participants • Income data not collected for the ED Staff/Providers Arm
Income
$100,001 to $150,000
4 Participants
n=76 Participants • Income data not collected for the ED Staff/Providers Arm
4 Participants
n=75 Participants • Income data not collected for the ED Staff/Providers Arm
8 Participants
n=151 Participants • Income data not collected for the ED Staff/Providers Arm
Income
More than $150,000
3 Participants
n=76 Participants • Income data not collected for the ED Staff/Providers Arm
4 Participants
n=75 Participants • Income data not collected for the ED Staff/Providers Arm
7 Participants
n=151 Participants • Income data not collected for the ED Staff/Providers Arm
Income
Decline to answer
17 Participants
n=76 Participants • Income data not collected for the ED Staff/Providers Arm
11 Participants
n=75 Participants • Income data not collected for the ED Staff/Providers Arm
28 Participants
n=151 Participants • Income data not collected for the ED Staff/Providers Arm
Insurance
Medicare
25 Participants
n=76 Participants • Insurance data not collected for the ED Staff/Providers Arm
19 Participants
n=75 Participants • Insurance data not collected for the ED Staff/Providers Arm
44 Participants
n=151 Participants • Insurance data not collected for the ED Staff/Providers Arm
Insurance
Medicaid
16 Participants
n=76 Participants • Insurance data not collected for the ED Staff/Providers Arm
23 Participants
n=75 Participants • Insurance data not collected for the ED Staff/Providers Arm
39 Participants
n=151 Participants • Insurance data not collected for the ED Staff/Providers Arm
Insurance
Private insurance
32 Participants
n=76 Participants • Insurance data not collected for the ED Staff/Providers Arm
23 Participants
n=75 Participants • Insurance data not collected for the ED Staff/Providers Arm
55 Participants
n=151 Participants • Insurance data not collected for the ED Staff/Providers Arm
Insurance
No insurance
2 Participants
n=76 Participants • Insurance data not collected for the ED Staff/Providers Arm
6 Participants
n=75 Participants • Insurance data not collected for the ED Staff/Providers Arm
8 Participants
n=151 Participants • Insurance data not collected for the ED Staff/Providers Arm
Insurance
Decline to answer
1 Participants
n=76 Participants • Insurance data not collected for the ED Staff/Providers Arm
4 Participants
n=75 Participants • Insurance data not collected for the ED Staff/Providers Arm
5 Participants
n=151 Participants • Insurance data not collected for the ED Staff/Providers Arm
Location of Pain
Abdomen
14 Participants
n=76 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
14 Participants
n=75 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
28 Participants
n=151 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
Location of Pain
Head
7 Participants
n=76 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
6 Participants
n=75 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
13 Participants
n=151 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
Location of Pain
Flank
3 Participants
n=76 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
2 Participants
n=75 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
5 Participants
n=151 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
Location of Pain
Chest
2 Participants
n=76 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
2 Participants
n=75 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
4 Participants
n=151 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
Location of Pain
Back
25 Participants
n=76 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
27 Participants
n=75 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
52 Participants
n=151 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
Location of Pain
Extremity
16 Participants
n=76 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
22 Participants
n=75 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
38 Participants
n=151 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
Location of Pain
Neck
1 Participants
n=76 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
0 Participants
n=75 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
1 Participants
n=151 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
Location of Pain
Multiple
6 Participants
n=76 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
1 Participants
n=75 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
7 Participants
n=151 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
Location of Pain
Other
2 Participants
n=76 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
1 Participants
n=75 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
3 Participants
n=151 Participants • Location of Pain data not collected for the ED Staff/Providers Arm
Prior Acupuncture
19 Participants
n=76 Participants • Prior Acupuncture data not collected for the ED Staff/Providers Arm
17 Participants
n=75 Participants • Prior Acupuncture data not collected for the ED Staff/Providers Arm
36 Participants
n=151 Participants • Prior Acupuncture data not collected for the ED Staff/Providers Arm
Pain Intensity
7.4 units on a scale
STANDARD_DEVIATION 2.2 • n=76 Participants • Pain Intensity data not collected for the ED Staff/Providers Arm
7.1 units on a scale
STANDARD_DEVIATION 2.3 • n=75 Participants • Pain Intensity data not collected for the ED Staff/Providers Arm
7.3 units on a scale
STANDARD_DEVIATION 2.2 • n=151 Participants • Pain Intensity data not collected for the ED Staff/Providers Arm
Anxiety- acute
4.5 units on a scale
STANDARD_DEVIATION 3.4 • n=76 Participants • Anxiety- acute data not collected for the ED Staff/Providers Arm
4.1 units on a scale
STANDARD_DEVIATION 3.4 • n=75 Participants • Anxiety- acute data not collected for the ED Staff/Providers Arm
4.3 units on a scale
STANDARD_DEVIATION 3.4 • n=151 Participants • Anxiety- acute data not collected for the ED Staff/Providers Arm

PRIMARY outcome

Timeframe: At Enrollment

Population: Patients who were eligible AND approached.

The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.

Outcome measures

Outcome measures
Measure
Total Approached
n=632 Participants
Total approached across all 3 sites
University Hospitals/Case Western
n=220 Participants
Patients approached at University Hospitals/Case Western
VUMC
n=300 Participants
Patients approached at VUMC
UCSD
n=112 Participants
Patients approached at UCSD
Successful Recruitment of Participants Into the Study.
26.1 Percentage of participants enrolled
27.7 Percentage of participants enrolled
16.3 Percentage of participants enrolled
49.1 Percentage of participants enrolled

SECONDARY outcome

Timeframe: At post treatment (45-60 minutes)

Population: Participants who enrolled

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.

Outcome measures

Outcome measures
Measure
Total Approached
n=165 Participants
Total approached across all 3 sites
University Hospitals/Case Western
n=61 Participants
Patients approached at University Hospitals/Case Western
VUMC
n=49 Participants
Patients approached at VUMC
UCSD
n=55 Participants
Patients approached at UCSD
Percentage of Participants Retained in the Study at Post Treatment
91.5 percentage of patients retained at post
98.4 percentage of patients retained at post
95.5 percentage of patients retained at post
80 percentage of patients retained at post

SECONDARY outcome

Timeframe: One-week after the participant was discharged from the ED

Population: Participants who enrolled

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.

Outcome measures

Outcome measures
Measure
Total Approached
n=165 Participants
Total approached across all 3 sites
University Hospitals/Case Western
n=61 Participants
Patients approached at University Hospitals/Case Western
VUMC
n=49 Participants
Patients approached at VUMC
UCSD
n=55 Participants
Patients approached at UCSD
Percentage of Patients Retained at 1-week Follow up
77.6 percentage of patients retained at 1-wk
82.0 percentage of patients retained at 1-wk
81.6 percentage of patients retained at 1-wk
69.1 percentage of patients retained at 1-wk

SECONDARY outcome

Timeframe: At post-treatment (45-60 minutes after baseline)

Population: Participants who has Post-treatment scores and answered 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).

Outcome measures

Outcome measures
Measure
Total Approached
n=140 Participants
Total approached across all 3 sites
University Hospitals/Case Western
n=69 Participants
Patients approached at University Hospitals/Case Western
VUMC
n=71 Participants
Patients approached at VUMC
UCSD
Patients approached at UCSD
Patient Satisfaction Question 1 at Post-treatment
3.91 units on a scale
Standard Deviation 1.23
4.36 units on a scale
Standard Deviation 1.06
3.46 units on a scale
Standard Deviation 1.23

SECONDARY outcome

Timeframe: At post-treatment (45-60 minutes after baseline)

Population: Participants who has Post-treatment scores and answered 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).

Outcome measures

Outcome measures
Measure
Total Approached
n=139 Participants
Total approached across all 3 sites
University Hospitals/Case Western
n=68 Participants
Patients approached at University Hospitals/Case Western
VUMC
n=71 Participants
Patients approached at VUMC
UCSD
Patients approached at UCSD
Patient Satisfaction Question 2 at Post-treatment
4.13 units on a scale
Standard Deviation 1.12
4.57 units on a scale
Standard Deviation 0.78
3.70 units on a scale
Standard Deviation 1.22

SECONDARY outcome

Timeframe: One week after participant was discharged from the ED

Population: Participants who has Post-treatment scores and answered satisfaction question 1 at 1-week FU

"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).

Outcome measures

Outcome measures
Measure
Total Approached
n=133 Participants
Total approached across all 3 sites
University Hospitals/Case Western
n=69 Participants
Patients approached at University Hospitals/Case Western
VUMC
n=64 Participants
Patients approached at VUMC
UCSD
Patients approached at UCSD
Patient Satisfaction Question 1 at 1-Week
3.95 units on a scale
Standard Deviation 1.27
4.16 units on a scale
Standard Deviation 1.21
3.73 units on a scale
Standard Deviation 1.30

SECONDARY outcome

Timeframe: One week after participant was discharged from the ED

Population: Participants who has Post-treatment scores and answered satisfaction question 2 at 1-week FU

"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).

Outcome measures

Outcome measures
Measure
Total Approached
n=134 Participants
Total approached across all 3 sites
University Hospitals/Case Western
n=70 Participants
Patients approached at University Hospitals/Case Western
VUMC
n=64 Participants
Patients approached at VUMC
UCSD
Patients approached at UCSD
Patient Satisfaction Question 2 at 1 Week
3.98 units on a scale
Standard Deviation 1.23
4.19 units on a scale
Standard Deviation 1.16
3.75 units on a scale
Standard Deviation 1.27

SECONDARY outcome

Timeframe: After enrollment at the provider's site completed (~6 months after first enrollee).

Population: Providers who responded to the survey after their site completed enrollment.

"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.

Outcome measures

Outcome measures
Measure
Total Approached
n=125 Participants
Total approached across all 3 sites
University Hospitals/Case Western
Patients approached at University Hospitals/Case Western
VUMC
Patients approached at VUMC
UCSD
Patients approached at UCSD
Provider Satisfaction Question1
2.19 score on a scale
Standard Deviation 1.07

SECONDARY outcome

Timeframe: After enrollment at the provider's site completed (~6 months after first enrollee).

Population: Providers who responded to the survey.

"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.

Outcome measures

Outcome measures
Measure
Total Approached
n=124 Participants
Total approached across all 3 sites
University Hospitals/Case Western
Patients approached at University Hospitals/Case Western
VUMC
Patients approached at VUMC
UCSD
Patients approached at UCSD
Provider Satisfaction Question 2
2.50 score on a scale
Standard Deviation 1.11

SECONDARY outcome

Timeframe: After enrollment at the provider's site completed (~6 months after first enrollee).

Population: Providers who responded to the survey and were exposed to ACUITY

"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

Outcome measures

Outcome measures
Measure
Total Approached
n=32 Participants
Total approached across all 3 sites
University Hospitals/Case Western
Patients approached at University Hospitals/Case Western
VUMC
Patients approached at VUMC
UCSD
Patients approached at UCSD
Provider Satisfaction Question 3
3.03 score on a scale
Standard Deviation 0.90

SECONDARY outcome

Timeframe: After enrollment at the provider's site completed (~6 months after first enrollee).

Population: Providers who responded to the survey and were exposed to ACUITY

"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

Outcome measures

Outcome measures
Measure
Total Approached
n=32 Participants
Total approached across all 3 sites
University Hospitals/Case Western
Patients approached at University Hospitals/Case Western
VUMC
Patients approached at VUMC
UCSD
Patients approached at UCSD
Provider Satisfaction Que4
0.38 score on a scale
Standard Deviation 0.66

Adverse Events

Acupuncture

Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths

Usual Care

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

ED Staff/Providers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Acupuncture
n=83 participants at risk
This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture. Acupuncture for pain management: A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room. Usual care for pain management: Patient will receive usual care for pain management.
Usual Care
n=82 participants at risk
This arm will receive usual care for pain management. Usual care for pain management: Patient will receive usual care for pain management.
ED Staff/Providers
n=125 participants at risk
ED Staff and Providers were asked complete 2 questions about their perceptions of acupuncture in the ED. If the ED staff or providers had direct contact with the ACUITY study in their ED, then they were asked to complete 2 additional questions inquiring about how ACUITY may have impacted the ED.
Vascular disorders
Death
1.2%
1/83 • Number of events 1 • Any adverse event from baseline to 4 weeks for the Acupuncture and Usual Care Arms, approximately 6 months for the ED Staff/Providers Arm
0.00%
0/82 • Any adverse event from baseline to 4 weeks for the Acupuncture and Usual Care Arms, approximately 6 months for the ED Staff/Providers Arm
0.00%
0/125 • Any adverse event from baseline to 4 weeks for the Acupuncture and Usual Care Arms, approximately 6 months for the ED Staff/Providers Arm
Vascular disorders
Hospitalization for Suspected Stroke
0.00%
0/83 • Any adverse event from baseline to 4 weeks for the Acupuncture and Usual Care Arms, approximately 6 months for the ED Staff/Providers Arm
1.2%
1/82 • Number of events 1 • Any adverse event from baseline to 4 weeks for the Acupuncture and Usual Care Arms, approximately 6 months for the ED Staff/Providers Arm
0.00%
0/125 • 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

Adverse event data not reported

Additional Information

Jeffery Dusek

University California-Irvine

Phone: 617-519-8082

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place