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NCT04290741 · ClinicalTrials.gov registry record · NA
Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 599
- Enrollment target
NCT04290741 is a NA study that has completed, run by Duke University. The registered enrollment target is 599 participants.
The verdict
NCT04290741, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 599 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Auricular (Battlefield) Acupuncture
- PROCEDURE Peripheral Acupuncture
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 599 participants |
| Start Date | 2020-02-10 |
| Est. Completion | 2023-06-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04290741
The ClinicalTrials.gov registry entry for NCT04290741 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 599 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Auricular (Battlefield) Acupuncture is the first listed.
NCT04290741 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04290741 about?
NCT04290741 is a clinical study titled "Emergency Department Acupuncture for Acute Musculoskeletal Pain Management". 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-p...
What is the current status of trial NCT04290741?
This trial is currently completed. It is a NA study. The enrollment target is 599 participants. The study started on 2020-02-10. Estimated completion is 2023-06-15.
What interventions are being tested in trial NCT04290741?
The interventions under investigation include: Auricular (Battlefield) Acupuncture (PROCEDURE), Peripheral Acupuncture (PROCEDURE).
Who is sponsoring clinical trial NCT04290741?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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