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Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04290741
Recruitment Status : Enrolling by invitation
First Posted : March 2, 2020
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
The Duke Endowment
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE February 26, 2020
First Posted Date  ICMJE March 2, 2020
Last Update Posted Date January 11, 2022
Actual Study Start Date  ICMJE February 10, 2020
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2021)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
  • Number of ED patients eligible for recruitment as measured by patient log [ Time Frame: Post implementation, up to 6 weeks ]
  • Mean number of patients enrolled each day 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 ]
  • Time in minutes for ED based acupuncture session [ Time Frame: Post ED acupuncture session, up to 1 hour ]
  • 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 ]
  • 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
  • Change in duration of acute pain episode [ Time Frame: 2 and 4 weeks post ED discharge ]
  • Number of patient reported return ED visits for pain since enrollment [ Time Frame: 4 weeks post discharge ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2021)
  • Change in function [ Time Frame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge ]
    PROMIS-29
  • Change in cognitive function [ Time Frame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge ]
    Neuro-QoL
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
Official Title  ICMJE Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Musculoskeletal Pain
Intervention  ICMJE
  • Procedure: Auricular (Battlefield) Acupuncture
    Placement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain.
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Auricular (Battlefield) Acupuncture
  • 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
    Intervention: Procedure: Peripheral Acupuncture
  • No Intervention: Control
    Standard of care without acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 7, 2021)
750
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2020)
220
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04290741
Other Study ID Numbers  ICMJE Pro00104140
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • The Duke Endowment
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
Investigators  ICMJE
Principal Investigator: Stephanie Eucker, MD, PhD Duke University
PRS Account Duke University
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP