Battlefield Acupressure for Acute Back Pain Management in the Emergency Department: Evaluating Whether Auricular Acupressure Can Reduce Opiate Administration for Painful Conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Pain Score
研究概览
简要总结
Patients frequently present to the emergency department for treatment of acute pain. In the emergency department, analgesic medications, particularly opiates, are most often the primary and only means of treatment. Alternative therapies such as traditional acupuncture have been studied and utilized in acute care settings; however, the need for extensive training, the use of needles, and state-specific acupuncture licensing requirements have been barriers to widespread use. Battlefield Auricular Acupressure (BAA) is a needle-free five-point technique on the outer ear that has been developed and employed by the military for a variety of painful conditions.
The primary objective of this study is to determine if battlefield auricular acupressure (BAA), compared to a sham procedure, results in a reduction in pain score at 30 minutes and 60 minutes post-intervention, by at least 2 Numerical Rating Scale (NRS) points below their baseline pain score, compared to participants receiving a sham procedure, for adults who present to the emergency department with a chief complaint of back pain and/or low back.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (Age ≥ 18) presenting to the ED
- •Chief complaint of back pain and/or low back pain
- •Pain score ≥ 4 on 0-10 NRS
排除标准
- •Pregnancy
- •Known allergy to adhesive
- •Presence of cochlear implants
- •Piercings at one or more of the BAA or sham sites
- •Having received analgesic medications within 4 hours of arrival to the ED or prior to intervention
- •Preferred language other than Spanish or English
- •Presence of a wound, sore, or active infection on the surface of the ear
结局指标
主要结局
Change in Pain Score
时间窗: Pain scores will be assessed at baseline (prior to intervention), 30 (± 5) minutes post-intervention and 60 (± 10) minutes post-intervention.
Pain scores will be measured using the Numeric Rating Scale (NRS) ranging from 0 ("no pain") to 10 ("worst pain imaginable")10. This study will compare the mean pain scores between the BAA group and the sham group.
次要结局
- Change in Pain Score at 24 Hours(24 hours post intervention)
- Incidence of Any Analgesic Medication Use(From intervention until ED disposition (on average 3.5 hours))
- Incidence of Opioid Medication Use(From intervention until ED disposition (on average 3.5 hours))
- Incidence of Non-Opioid Analgesic Medication Use(From intervention until ED disposition (on average 3.5 hours))
- Total Opioid Consumption in Morphine Milligram Equivalents (MME)(From intervention until ED disposition (on average 3.5 hours))
- Frequency of Non-Opioid Analgesic Doses(From intervention until ED disposition (on average 3.5 hours))