Musculoskeletal PainNCT04290741
Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
A study testing Auricular (Battlefield) Acupuncture and Peripheral Acupuncture in people with Musculoskeletal Pain, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Auricular (Battlefield) Acupuncture and Peripheral Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 599 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital Emergency Department
Durham, North Carolina, 27710
About this study
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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Auricular (Battlefield) Acupuncture, Peripheral Acupuncture
- Keywords
- Acupuncture, Pain, Emergency Department
- Medical subject headings
- Musculoskeletal Pain, Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular (Battlefield) AcupunctureProcedure or surgery
Placement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain.
Peripheral AcupunctureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Auricular (Battlefield) Acupuncture | Experimental | 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. Receives: Procedure: Auricular (Battlefield) Acupuncture |
| Peripheral Acupuncture | Experimental | 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 Receives: Procedure: Peripheral Acupuncture |
| Control | No intervention | Standard of care without acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score
11-point Numeric Rating Scale (NRS) for current pain
Measured: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Number of ED patients eligible for recruitment as measured by patient log
Measured: Post implementation, up to 6 weeks
Number of patients enrolled as measured by patient log
Measured: Post implementation, up to 6 weeks
Number of patients retained in study as measured by patient log
Measured: Post implementation, up to 6 weeks
Number of patients that found acupuncture satisfactory via satisfactory questionnaire
Likert-scale, agree disagree
Measured: Post implementation, up to 6 weeks
Number of outpatient acupuncture sessions attended
Measured: 4 weeks post discharge
Number of adverse events
Measured: Post implementation, up to 2 weeks
Secondary outcomes (5)
Change in function
PROMIS-29
Measured: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Change in cognitive function
Neuro-QoL
Measured: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Number of return ED visits
Measured: Up to one year post ED visit
Pain medications received
Measured: Up to three months post ED visit
Time in minutes for ED based acupuncture session
Measured: Post ED acupuncture session, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start10 Feb 2020
- Primary completion19 Apr 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Sponsor
- Investigators
- Mitchell Knisely, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290741
- Sponsor's protocol ID
- Pro00104140
- Status last verified
- Mar 2023
- First submitted
- 26 Feb 2020
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tupetz A, Frazier M, O'Regan A, Knisely M, TumSuden O, Walker E, Sununu C, Glass O, Miller-Maxwell A, Staton CA, Eucker SA. Participant experiences receiving acupuncture for acute musculoskeletal pain in an emergency department: A qualitative evaluation. PLoS One. 2025 Feb 12;20(2):e0318345. doi: 10.1371/journal.pone.0318345. eCollection 2025.
PubMed 39937807Eucker 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.
PubMed 36153034
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
- ClinicalTrials.gov ID
- NCT04290741
- Acronym / sponsor ID
- Pro00104140
- Conditions
- Musculoskeletal Pain
- Keywords
- Acupuncture, Pain, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Duke Endowment, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auricular (Battlefield) Acupuncture | Experimental | Procedure: Auricular (Battlefield) AcupunctureAuricular 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 | Experimental | Procedure: Peripheral AcupuncturePeripheral 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 |
| Control | No intervention | –Standard of care without acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Auricular (Battlefield) AcupuncturePlacement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain. | Procedure or surgery | Auricular (Battlefield) Acupuncture |
| Peripheral AcupuncturePlacement 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 | Procedure or surgery | Peripheral Acupuncture |
Primary outcome
Change in Pain Score
Time frame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
11-point Numeric Rating Scale (NRS) for current pain
Number of ED patients eligible for recruitment as measured by patient log
Time frame: Post implementation, up to 6 weeks
Number of patients enrolled as measured by patient log
Time frame: Post implementation, up to 6 weeks
Number of patients retained in study as measured by patient log
Time frame: Post implementation, up to 6 weeks
Number of patients that found acupuncture satisfactory via satisfactory questionnaire
Time frame: Post implementation, up to 6 weeks
Likert-scale, agree disagree
Number of outpatient acupuncture sessions attended
Time frame: 4 weeks post discharge
Number of adverse events
Time frame: Post implementation, up to 2 weeks
5 secondary outcomes
Change in function
Time frame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Change in cognitive function
Time frame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Number of return ED visits
Time frame: Up to one year post ED visit
Pain medications received
Time frame: Up to three months post ED visit
Time in minutes for ED based acupuncture session
Time frame: Post ED acupuncture session, up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 39937807Tupetz A, Frazier M, O'Regan A, Knisely M, TumSuden O, Walker E, Sununu C, Glass O, Miller-Maxwell A, Staton CA, Eucker SA. Participant experiences receiving acupuncture for acute musculoskeletal pain in an emergency department: A qualitative evaluation. PLoS One. 2025 Feb 12;20(2):e0318345. doi: 10.1371/journal.pone.0318345. eCollection 2025.
- Derived from this study: PubMed 36153034Eucker 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.
- 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.
Mitchell Knisely, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular (Battlefield) Acupuncture and Peripheral Acupuncture in people with Musculoskeletal Pain, run by Duke University at 1 site 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 3 inclusion and 7 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Pain Score (time frame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge). The study lists 7 primary outcomes in all. 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 NCT04290741, which also lists 2 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 12 May 2026.