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Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

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ClinicalTrials.gov Identifier: NCT04290741
Recruitment Status : Enrolling by invitation
First Posted : March 2, 2020
Last Update Posted : May 11, 2021
Sponsor:
Collaborators:
The Duke Endowment
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by (Responsible Party):
Duke University

Brief Summary:

The purpose of this project is to determine the feasibility and acceptability 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.


Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Procedure: Auricular (Battlefield) Acupuncture Procedure: Peripheral Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Auricular (Battlefield) Acupuncture
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.
Procedure: Auricular (Battlefield) Acupuncture
Placement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain.

Experimental: Peripheral Acupuncture
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
Procedure: Peripheral Acupuncture
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

No Intervention: Control
Standard of care without acupuncture



Primary Outcome Measures :
  1. Number of ED patients eligible for recruitment as measured by patient log [ Time Frame: Post implementation, up to 6 weeks ]
  2. Mean number of patients enrolled each day as measured by patient log [ Time Frame: Post implementation, up to 6 weeks ]
  3. Number of patients retained in study as measured by patient log [ Time Frame: Post implementation, up to 6 weeks ]
  4. Time in minutes for ED based acupuncture session [ Time Frame: Post ED acupuncture session, up to 1 hour ]
  5. Number of patients that found acupuncture satisfactory via satisfactory questionnaire [ Time Frame: Post implementation, up to 6 weeks ]
    Likert-scale, agree disagree

  6. Number of outpatient acupuncture sessions attended [ Time Frame: 4 weeks post discharge ]
  7. Number of adverse events [ Time Frame: Post implementation, up to 2 weeks ]
  8. 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

  9. Change in duration of acute pain episode [ Time Frame: 2 and 4 weeks post ED discharge ]
  10. Number of patient reported return ED visits for pain since enrollment [ Time Frame: 4 weeks post discharge ]
  11. Change in use of opioids by patient report [ Time Frame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290741


Locations
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United States, North Carolina
Duke University Hospital Emergency Department
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
The Duke Endowment
Substance Abuse and Mental Health Services Administration (SAMHSA)
Investigators
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Principal Investigator: Stephanie Eucker, MD, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04290741    
Other Study ID Numbers: Pro00104140
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Acupuncture
Pain
Emergency Department
Additional relevant MeSH terms:
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Musculoskeletal Pain
Emergencies
Disease Attributes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations