Clinical Trial

Acupuncture for Acute Musculoskeletal Pain Management

Study Description

Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

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. There are two phases in this study. Phase (1): Enrolled subjects will be randomized to Battlefield (auricular) 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. Phase (2) will analyze the first 60 patients to determine the most efficient method of acupuncture. The other type will be dropped and all subjects randomized to acupuncture will be in the same arm. All groups will complete questionnaires at 1 hour post-randomization, 2 and 4 weeks after ED visit. Subjects may also have a blood draw for biomarker analysis while during their ED visit. A two-stage adaptive trial design with one planned interim analysis will be utilized for this trial. The two-stage adaptive trial design consists of two stages of treatment selection stage and efficacy (pain reduction) confirmation stage. 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. The primary endpoint will be the improvement in pain score (evaluated based on of 0-11 pain scale) at the discharge from the ED.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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

Additional Information

Official Study Title

Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

Clinical Trial ID

NCT04290741

ParticipAid ID

bkRzra