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| Name | Class |
|---|---|
| The Duke Endowment | OTHER |
| Substance Abuse and Mental Health Services Administration (SAMHSA) | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
|
| Control | No Intervention | Standard of care without acupuncture |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular (Battlefield) Acupuncture | Procedure | Placement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score | 11-point Numeric Rating Scale (NRS) for current pain | 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 | Post implementation, up to 6 weeks | |
| Number of patients enrolled as measured by patient log | Post implementation, up to 6 weeks | |
| Number of patients retained in study as measured by patient log | Post implementation, up to 6 weeks | |
| Number of patients that found acupuncture satisfactory via satisfactory questionnaire | Likert-scale, agree disagree | Post implementation, up to 6 weeks |
| Number of outpatient acupuncture sessions attended | 4 weeks post discharge | |
| Number of adverse events | Post implementation, up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in function | PROMIS-29 | ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge |
| Change in cognitive function | Neuro-QoL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Knisely, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital Emergency Department | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36153034 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2023 | Jul 3, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Peripheral Acupuncture | Procedure | 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 |
|
| ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge |
| Number of return ED visits | Up to one year post ED visit |
| Pain medications received | Up to three months post ED visit |
| Time in minutes for ED based acupuncture session | Post ED acupuncture session, up to 1 hour |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |