Center for Integrative Medicine - Shock Trauma Acupuncture Research (CIM-STAR) Study
Abstract
Over the last decades, emergency medicine has advanced exponentially in its ability to save lives. Yet, amidst this technical sophistication, not all patient care challenges can be met. Recently, the Center for Integrative Medicine and the R. Adam Cowley Shock Trauma Center at the University of Maryland School of Medicine began to explore solutions for some of the unmet need, setting in motion a collaboration between acute care and traditional Chinese medicine for unique innovations in healing.
The first step in this process is a randomized controlled pilot study (n=60) of electro-acupuncture to relieve pain and modulate biomarkers of inflammation and stress among post-operative, non-brain-injury trauma patients. We hypothesize a beneficial impact of acupuncture on reduced morphine consumption and regulation of pro- and anti-inflammatory cytokines and stress hormones by day five of the patient's stay. The pilot study will allow us to assess compliance and feasibility of conducting such an intervention in this setting, and to collect preliminary efficacy data toward a larger grant application.
The specific aims of the pilot study are to collect preliminary data on the effect of post-operative electro-acupuncture during the first three days following surgery on total morphine-equivalent analgesic consumption, peripheral blood levels of pro-inflammatory cytokines Interleukin (IL)-1β, IL-1r, IL-6, IL-8, tumor necrosis factor (TNF)-α and anti-inflammatory cytokines IL-4 and IL-10, stress hormone cortisol, beta-endorphins, as well as reported pain, and patient quality of life. In addition, data on the feasibility of conducting a study of acupuncture in the Shock Trauma Center will be collected.
All patients meeting inclusion criteria on Monday mornings will be invited to participate in the study. After providing informed consent, patients will be randomized to real acupuncture plus conventional care, or to conventional care alone. Acupuncture will be given once a day for 20 minutes for three days, with patients followed out to five days. Verbal pain assessment will be carried out before and after acupuncture, as well as each afternoon. All participants will have access to patient-controlled analgesia (PCA) pump. PCA use data as well as intravenous and oral analgesics dosage will be collected from each subject's medical record once per day. Total morphine-equivalent analgesic consumption will be calculated.
Data analysis will be performed on an intention-to-treat basis, and focus on the difference between treatment groups in cumulative morphine-equivalent dose over three days, and mean cytokine, beta-endorphin and cortisol levels on days 1-3. Analysis of feasibility data will include enrollment rate, compliance rate, completion rate, as well as administrative and logistic issues.
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