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NCT04880733 · ClinicalTrials.gov registry record · NA
Acupuncture in the Emergency Department for Pain Management
A NA study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- NA
- Development phase
- 290
- Enrollment target
NCT04880733 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 290 participants.
The verdict
NCT04880733, a NA study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- NA
- Development phase
- 290 participants
- Enrollment target
Study Summary
Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a \~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (\~10 per site) and acupuncture patients (\~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).
Interventions
- PROCEDURE Acupuncture for pain management
- OTHER Usual care for pain management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2025-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04880733
The ClinicalTrials.gov registry entry for NCT04880733 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Western Reserve University, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Acupuncture for pain management is the first listed.
NCT04880733 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04880733 about?
NCT04880733 is a clinical study titled "Acupuncture in the Emergency Department for Pain Management". Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites Univers...
What is the current status of trial NCT04880733?
This trial is currently completed. It is a NA study. The enrollment target is 290 participants. The study started on 2021-05-03. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT04880733?
The interventions under investigation include: Acupuncture for pain management (PROCEDURE), Usual care for pain management (OTHER).
Who is sponsoring clinical trial NCT04880733?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
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