Acupuncture for Pain Control in the Emergency Department
2015年12月3日 更新者：Gi Young Yang、Korean Medicine Hospital of Pusan National University
Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial
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.
研究概览
地位
终止
研究类型
介入性
注册 (实际的)
17
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kyungsangnamdo
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Yangsan、Kyungsangnamdo、大韩民国、626770
- Pusan National University Yangsan Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Standard ED management alone
Radiographic and physical examinations to exclude fractures or other serious conditions will be performed for all patients before considering eligibility in the study.
After completion of the examination, patients who have pain of at least a level 4, as measured by the Wong-Baker scale (ranges 0 to 10), will receive intravenous or intramuscular injections of non-steroidal anti-inflammatory drugs (NSAIDs) for immediate pain control.
All patients will be observed 30 minutes after the administration of the NSAIDs.
In patients with primary headaches who respond poorly to the initial NSAID injection, an intravenous injection of opioid analgesics will be provided.
After these initial standard ED management interventions, patients who are still suffering from acute pain will be asked to participate in the trial.
During the study, rescue medication for immediate pain control will be allowed for patients allocated to both groups.
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实验性的：Acupuncture plus standard ED management
The patients in this group will receive a single session of individualized acupuncture treatment delivered by a certified Korean Medicine Doctor (KMD) specialized (or in-training) in acupuncture and moxibustion medicine and with at least 3 years of clinical experience.
The acupuncture formulas will be composed based on the individual patient's symptoms and at the KMD's discretion.
Acupuncture treatments will be provided in line with standard ED management, the same as in the control group.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Immediate reduction in pain intensity
大体时间：at ED discharge (within 3 hours from ED admission)
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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)
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at ED discharge (within 3 hours from ED admission)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Short-term reduction in pain intensity
大体时间：72 hours after the ED discharge
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Participant-perceived reduction of pain intensity will be measured by the the pain NRS (Range 0 to 10 referring 0 to no pain and 10 to extreme pain)
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72 hours after the ED discharge
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Short-term disability due to neck pain (only for patients with neck pain)
大体时间：72 hours after the ED discharge
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Participant-perceived reduction of disability due to neck pain will be measured by a 10-item questionnaire.
Changes from baseline on the Neck Disability Index (NDI) will be used.
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72 hours after the ED discharge
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Immediate and short-term patient global assessment for treatment outcomes
大体时间：at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
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Patients' global assessments for overall treatment outcomes will be measured by a single item with a 5-point Likert scale question (much improved, somewhat improved, the same as baseline, somewhat worsened, much worsened)
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at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
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Use of rescue medication in the ED
大体时间：at ED discharge (within 3 hours from ED admission)
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Use of additional rescue medication for relieving pain will be measured by electronic medical charts
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at ED discharge (within 3 hours from ED admission)
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Use of additional medication or healthcare resources
大体时间：72 hours after the ED discharge
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Use of additional medication or healthcare resources (such as hospital admissions and outpatient clinic visits) will be measured by patients' self-reports via telephone interviews.
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72 hours after the ED discharge
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Length of stay in the ED
大体时间：at ED discharge (within 3 hours from ED admission)
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Length of stay in the ED (from group allocation to the ED discharge) will be measured by electronic medical charts.
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at ED discharge (within 3 hours from ED admission)
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Proportion of treatment responder
大体时间：at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
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Proportion of treatment responder is defined as patients who have experienced at least a 50% reduction in pain intensity from baseline values; these values will be calculated using the pain intensity VAS scores.
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at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge
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Adverse events
大体时间：at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge
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All expected or unexpected adverse events in both groups will be measured during the allocated intervention process and during the entire follow-up period.
Types and frequency of occurrences of adverse events will be measured.
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at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Patient acceptability of acupuncture treatment
大体时间：72 hours after the ED discharge
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Participant-perceived acceptability of acupuncture treatment will be measured by a single item with a 5-point Likert scale question (acupuncture was very helpful, somewhat helpful, don't know, somewhat not helpful, very not helpful).
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72 hours after the ED discharge
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Gi Young Yang, PhD、Korean Medicine Hospital, Pusan National University
- 首席研究员：Ji Ho Ryu, PhD、Pusan National University Yangsan Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年12月1日
初级完成 (实际的)
2015年11月1日
研究完成 (实际的)
2015年11月1日
研究注册日期
首次提交
2013年11月27日
首先提交符合 QC 标准的
2013年12月11日
首次发布 (估计)
2013年12月17日
研究记录更新
最后更新发布 (估计)
2015年12月7日
上次提交的符合 QC 标准的更新
2015年12月3日
最后验证
2015年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Standard ED management alone的临床试验
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George Washington UniversityTranscultural Psychosocial Organization Nepal完全的