Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Immediate reduction in pain intensity
研究概览
简要总结
Acupuncture is widely used for managing acute and chronic pain conditions. In the context of an emergency department (ED), patients often present with non-emergent acute pain symptoms. This may result in a delayed triage process and inefficient emergent management. An integrative patient-care approach in emergency departments has been explored that may improve patient satisfaction and promote efficient use of healthcare resources for non-emergent patients in the ED. This implies there is a potential role for acupuncture in such contexts. The aim of this pilot study is to assess the effectiveness and safety of acupuncture as an add-on intervention for patients with non-emergent acute musculoskeletal pain and primary headaches in an ED setting.
Hypotheses of this study are as follows:
- A single session of add-on acupuncture, with standard ED management, can reduce pain levels in non-emergent acute pain, compared to standard ED management alone.
- A single session of add-on acupuncture to standard ED management can reduce additional consumption of healthcare resources for management of non-emergent acute pain, compared to standard ED management alone.
This study aimed to include 40 participants, 20 in the acupuncture plus standard ED management group and 20 in the standard ED management alone group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 19 years with acute pain defined as pain occurring within 72 hours of ED presentation
- •Acute neck pain with no evidence of neurological abnormality
- •Acute headache which meets the classification criteria of a primary headache as described by the International Headache Society (code 1 to 4)
- •Acute ankle injury with no evidence of fracture or complete tear of ligaments
排除标准
- •Any suspected non-musculoskeletal cause (neoplasm or neurological complications) for neck or ankle pain
- •Any suspected secondary headaches classified by codes 5 to 12 in the International Classification of Headache Disorders, 2nd edition
- •Pain due to bone fracture or joint dislocation
- •Pain with fever (defined by a temperature above 37.5 °C)
- •Inappropriate at the ED physician's discretion
- •Pain level of less than 4 points of pain intensity on the Numerical Rating Scale (NRS) (range 0 to 10) at the completion of observations after the standard ED management
- •Pregnant women
结局指标
主要结局
Immediate reduction in pain intensity
时间窗: at ED discharge (within 3 hours from ED admission)
Participant-perceived reduction of pain intensity will be measured by the pain Numerical Rating Scale (NRS) (Range 0 to 10 referring 0 to no pain and 10 to extreme pain)
次要结局
- Short-term reduction in pain intensity(72 hours after the ED discharge)
- Use of additional medication or healthcare resources(72 hours after the ED discharge)
- Immediate and short-term patient global assessment for treatment outcomes(at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge)
- Length of stay in the ED(at ED discharge (within 3 hours from ED admission))
- Use of rescue medication in the ED(at ED discharge (within 3 hours from ED admission))
- Short-term disability due to neck pain (only for patients with neck pain)(72 hours after the ED discharge)
- Proportion of treatment responder(at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge)
- Adverse events(at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge)
研究者
Gi Young Yang
Assistant Professor
Korean Medicine Hospital of Pusan National University