Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
Primary Purpose
Musculoskeletal Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular (Battlefield) Acupuncture
Peripheral Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain focused on measuring Acupuncture, Pain, Emergency Department
Eligibility Criteria
Inclusion Criteria:
- Adults age 18 or older
- Clinical diagnosis of acute (≤7 days) musculoskeletal pain as determined by an ED provider
- Able to read and understand the consent form in English
Exclusion Criteria:
- Unable to receive acupuncture due to injury or infection of acupuncture sites
- Unwilling or unable to attend the follow-up outpatient acupuncture clinic
- Severe hearing or speech impairment
- Cognitive impairment, including evidence of drug, medication or alcohol intoxication, that would prevent comprehension of consent procedures or study measures and procedures
- Critical illness
- Deformity
- Medical condition that would contraindicate safe participation as determine by an ED provider
Sites / Locations
- Duke University Hospital Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Auricular (Battlefield) Acupuncture
Peripheral Acupuncture
Control
Arm Description
Auricular acupuncture involves placement of needles based on battlefield acupuncture protocol which involves the placement of needles in up to 5 sites on each ear to treat pain.
Peripheral acupuncture involves placement of needles in up to 30 specific sites in the head, neck, arms from the shoulders to the hands, and legs from the knees to the feet
Standard of care without acupuncture
Outcomes
Primary Outcome Measures
Change in Pain Score
11-point Numeric Rating Scale (NRS) for current pain
Number of ED patients eligible for recruitment as measured by patient log
Number of patients enrolled as measured by patient log
Number of patients retained in study as measured by patient log
Number of patients that found acupuncture satisfactory via satisfactory questionnaire
Likert-scale, agree disagree
Number of outpatient acupuncture sessions attended
Number of adverse events
Secondary Outcome Measures
Change in function
PROMIS-29
Change in cognitive function
Neuro-QoL
Number of return ED visits
Pain medications received
Time in minutes for ED based acupuncture session
Full Information
NCT ID
NCT04290741
First Posted
February 26, 2020
Last Updated
July 3, 2023
Sponsor
Duke University
Collaborators
The Duke Endowment, Substance Abuse and Mental Health Services Administration (SAMHSA)
1. Study Identification
Unique Protocol Identification Number
NCT04290741
Brief Title
Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
Official Title
Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
April 19, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
The Duke Endowment, Substance Abuse and Mental Health Services Administration (SAMHSA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this project is to determine the feasibility, acceptability and effectiveness of acupuncture in the Emergency Department (ED) for treating acute musculoskeletal pain. The overall goal is to reduce acute and subacute opioid use by improving acute pain, anxiety and disability with non-pharmacologic treatment options at a critical entry point for patients into the healthcare system. This full-scale randomized controlled trial (RCT) has been statistically powered to test the effectiveness of ED-based acupuncture for both one-hour (Stage 1) and one-month (Stage 2) pain reduction outcomes. The feasibility will be assessed based on patient recruitment and retention rates, while the acceptability will be assessed using patient reported outcomes and qualitative semi-structured interviews.
Stage 1 is a 2-phase study design. Phase (1): Enrolled subjects will be randomized to auricular (ear) acupuncture, peripheral acupuncture, or the control group receiving no acupuncture. Subjects assigned to an acupuncture arm will receive information and access to acupuncture in an outpatient clinic for the 4 weeks following ED visit. Subjects may also have a blood draw for biomarker analysis during their ED visit. A planned interim analysis of the first 60 patients (2/3 of the Phase 1 arm completed) will be completed to select the more effective and/or acceptable arm for Phase 2. At interim analysis, it was determined by the DSMB that neither arm was superior, so the recommendation was to continue Stage 1 Phase 2 unchanged with 3 arms. Stage 1 is complete, and we will proceed with Stage 2 powered to the 4-week pain score outcome. Stage 2 will proceed with the same procedures as stage 1, only powered to a different outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
Acupuncture, Pain, Emergency Department
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
599 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular (Battlefield) Acupuncture
Arm Type
Experimental
Arm Description
Auricular acupuncture involves placement of needles based on battlefield acupuncture protocol which involves the placement of needles in up to 5 sites on each ear to treat pain.
Arm Title
Peripheral Acupuncture
Arm Type
Experimental
Arm Description
Peripheral acupuncture involves placement of needles in up to 30 specific sites in the head, neck, arms from the shoulders to the hands, and legs from the knees to the feet
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care without acupuncture
Intervention Type
Procedure
Intervention Name(s)
Auricular (Battlefield) Acupuncture
Intervention Description
Placement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain.
Intervention Type
Procedure
Intervention Name(s)
Peripheral Acupuncture
Intervention Description
Placement of needles in up to 30 specific sites in the head, neck, arms from the shoulders to the hands, and legs from the knees to the feet
Primary Outcome Measure Information:
Title
Change in Pain Score
Description
11-point Numeric Rating Scale (NRS) for current pain
Time Frame
ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Title
Number of ED patients eligible for recruitment as measured by patient log
Time Frame
Post implementation, up to 6 weeks
Title
Number of patients enrolled as measured by patient log
Time Frame
Post implementation, up to 6 weeks
Title
Number of patients retained in study as measured by patient log
Time Frame
Post implementation, up to 6 weeks
Title
Number of patients that found acupuncture satisfactory via satisfactory questionnaire
Description
Likert-scale, agree disagree
Time Frame
Post implementation, up to 6 weeks
Title
Number of outpatient acupuncture sessions attended
Time Frame
4 weeks post discharge
Title
Number of adverse events
Time Frame
Post implementation, up to 2 weeks
Secondary Outcome Measure Information:
Title
Change in function
Description
PROMIS-29
Time Frame
ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Title
Change in cognitive function
Description
Neuro-QoL
Time Frame
ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Title
Number of return ED visits
Time Frame
Up to one year post ED visit
Title
Pain medications received
Time Frame
Up to three months post ED visit
Title
Time in minutes for ED based acupuncture session
Time Frame
Post ED acupuncture session, up to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults age 18 or older
Clinical diagnosis of acute (≤7 days) musculoskeletal pain as determined by an ED provider
Able to read and understand the consent form in English
Exclusion Criteria:
Unable to receive acupuncture due to injury or infection of acupuncture sites
Unwilling or unable to attend the follow-up outpatient acupuncture clinic
Severe hearing or speech impairment
Cognitive impairment, including evidence of drug, medication or alcohol intoxication, that would prevent comprehension of consent procedures or study measures and procedures
Critical illness
Deformity
Medical condition that would contraindicate safe participation as determine by an ED provider
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Eucker, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital Emergency Department
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36153034
Citation
Eucker SA, Glass O, Staton CA, Knisely MR, O'Regan A, De Larco C, Mill M, Dixon A, TumSuden O, Walker E, Dalton JC, Limkakeng A, Maxwell AMW, Gordee A, Kuchibhatla M, Chow S. Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial. BMJ Open. 2022 Sep 23;12(9):e061661. doi: 10.1136/bmjopen-2022-061661.
Results Reference
derived
Learn more about this trial
Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
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