Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

Musculoskeletal Pain Clinical Trial

Official title:

Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290741
• Other study ID #: Pro00104140
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: June 15, 2023

Study information

• Verified date: March 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: June 15, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Musculoskeletal Pain

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Hospital Emergency Department	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Substance Abuse and Mental Health Services Administration (SAMHSA), The Duke Endowment

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of ED patients eligible for recruitment as measured by patient log		Post implementation, up to 6 weeks
Primary	Number of patients enrolled as measured by patient log		Post implementation, up to 6 weeks
Primary	Number of patients retained in study as measured by patient log		Post implementation, up to 6 weeks
Primary	Number of patients that found acupuncture satisfactory via satisfactory questionnaire	Likert-scale, agree disagree	Post implementation, up to 6 weeks
Primary	Number of outpatient acupuncture sessions attended		4 weeks post discharge
Primary	Number of adverse events		Post implementation, up to 2 weeks
Secondary	Change in function	PROMIS-29	ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Secondary	Change in cognitive function	Neuro-QoL	ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Secondary	Number of return ED visits		Up to one year post ED visit
Secondary	Pain medications received		Up to three months post ED visit
Secondary	Time in minutes for ED based acupuncture session		Post ED acupuncture session, up to 1 hour