Auricular Acupuncture for the Acute Management of Pain in the Emergency Department
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Pain Intensity Measure (VAS score 0-10)
研究概览
简要总结
The purpose of the study is to test auricular (ear) acupuncture for the acute management of patient pain in the Emergency Department as an alternative and adjunct to standard medical treatment.
Currently, physicians who practice medicine here in the United States only have pharmacological intervention at their disposal as the only available treatment tool they have for the treatment and management of pain, and as a result, painkiller misuse, overdose, and death has become the leading health epidemic in America. American healthcare is in desperate need of alternative and safer ways to prevent prescription painkiller overdoses and to better manage pain. If prescription painkiller dependencies can be avoided at the source, potentially many lives and healthcare dollars can be saved. Acupuncture is an alternative treatment that has been effectively used to treat pain for thousands of years in countries around the world. The National Institutes of Health (NIH) and the United Nations World Health Organization (WHO) have stated that acupuncture is a safe and effective treatment for the management of pain. Supported by many studies illustrating seventy-five to ninety-nine percent effectiveness in treating pain with an instantaneous drop in pain by twenty-five to eighty percent, acupuncture appears to be the safest and most effective option available to manage pain syndromes in the emergency department.
Auricular acupuncture has demonstrated beneficial effects to reduce acute and chronic pain intensity. Specifically, for the thesis of this clinical trial, the investigators hypothesize that auricular acupuncture can be an effective alternative and/or adjunct treatment tool in the civilian emergency department for the acute management of pain.
In order to test the safety and efficacy of using auricular acupuncture in the emergency department, people presenting to the emergency department with pain who are willing to participate in the study will be randomized into three separate groups:
- Standard medical group (tape on ear + standard medical drug)
- Standard medical group plus auricular acupuncture (acupuncture + standard medical drug)
- Auricular acupuncture group (acupuncture + placebo pill)
The design of these groups will allow the investigators to best test the efficacy of auricular acupuncture versus the placebo effect and standard medical care as well as an adjunct to standard medical care. To accomplish the objective of this proposal, the investigators will pursue the following specific aims:
Specific Aim 1: To prove the efficacy of auricular acupuncture over a placebo group in the management of pain syndromes. By having the acupuncture group and sham acupuncture group, the investigators will be able to effectively compare the difference in pain levels with a placebo-group.
Specific Aim 2: To prove that auricular acupuncture is an effective alternative and/or adjunct to standard medical care in the Emergency Department.
By testing the efficacy of acupuncture in conjunction with standard medical treatment, the investigators expect to see a potentiation of analgesic effects, and this will be noted by an increased reduction in pain between the standard medical plus acupuncture group versus the standard group and acupuncture group.
Specific Aim 3: To prove that auricular acupuncture as an effective pain management alternative that decreases short-term prescription painkiller dependency.
Through a series of follow up questionnaires and a medication diary that the investigators will give to the patient prior to discharge, the investigators will track the patient's need and use of additional pain medications post treatment. These surveys will give a good indication as to the effectiveness of auricular acupuncture to reduce a patient's dependency on painkiller drugs in the short-term setting.
详细描述
All Emergency Department physicians willing to participate in the study will be trained on the Battlefield Acupuncture Protocol through a weekend workshop and training. The acupuncture protocol and training will be taught by consulting expert acupuncturists with extensive training and clinical experience with the protocol. The acupuncturists will be available throughout the duration of the study as consultants for the physicians at any time if they have questions about the treatment and/or protocol.
Patients presenting to the Emergency Department that meet all inclusion and exclusion criteria and are willing to participate in the study, have been screened and triaged appropriately, meet all of the inclusion and exclusion criteria for the study, and have given proper informed consent will be randomized into three separate groups:
- Standard medical group (tape on ear + standard medical drug)
- Standard medical group plus auricular acupuncture (acupuncture + standard medical drug)
- Auricular acupuncture group (acupuncture + placebo pill)
Each group will have the appearance of getting the same treatment, and all participants will be informed prior to treatment of each group they could possibly be in.
This is a single blind study with additional considerations to better limit bias. Prior to treatment, the physician will inform each patient of all of the steps utilized in the procedure. In an attempt to limit bias as much as possible, the physician will not know what treatment group the patient will be placed in until just prior to performing the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All hemodynamically stable, adult patients presenting to the Emergency Department (ED) with a chief complaint of pain AND a physician diagnosis of acute, non-critical, musculoskeletal pain.
- •Musculoskeletal pain includes pain to any bones, muscles, cartilage, or nerves associated with such.
- •Patients will be diagnosed by a physician as non-critical meaning they can be treated and sent home without needing to be admitted to the hospital.
- •Blood pressure: 90-180/60-110
- •Cardiac rate with no dysrhythmias 50-149
- •Ventilatory rate 10-35
- •Oxygen saturation >87%
- •Alert and able to follow commands and respond appropriately
排除标准
- •Patients that are altered and/or present with vital signs outside of the inclusion criteria ranges.
- •Those deemed in critical condition by triage nurse and/or ER physician.
- •Patients with a history of narcotic drug abuse/dependency.
- •Patients who have had Battlefield Acupuncture done in the past.
- •Pregnant or nursing women (confirmed by a pregnancy test)
- •Allergic to adhesive tape, gold, or other needle components
- •Allergic to aspirin, NSAIDs, or narcotics
- •Patients at risk for complications from indwelling acupuncture needles, such as patients with bleeding disorders, those who are immunosuppressed, or those with liver disease (Hepatitis C, cirrhosis, etc.)
研究组 & 干预措施
Standard Drug Group
Participants randomized into this group will be receiving the standard medical care and "placebo" acupuncture. For the placebo acupuncture procedure, the ASP® needles will be double taped onto the ear in the same anatomical position as the acupuncture groups. The needles will be taped so that the needles will never puncture the skin. The patients will then be given hydrocodone / acetaminophen 5mg/325mg (generic) with a prescription to take home and use as needed.
干预措施: Acupuncture (Device)
Standard Drug Group
Participants randomized into this group will be receiving the standard medical care and "placebo" acupuncture. For the placebo acupuncture procedure, the ASP® needles will be double taped onto the ear in the same anatomical position as the acupuncture groups. The needles will be taped so that the needles will never puncture the skin. The patients will then be given hydrocodone / acetaminophen 5mg/325mg (generic) with a prescription to take home and use as needed.
干预措施: Placebo Acupuncture (Procedure)
Standard Drug Group
Participants randomized into this group will be receiving the standard medical care and "placebo" acupuncture. For the placebo acupuncture procedure, the ASP® needles will be double taped onto the ear in the same anatomical position as the acupuncture groups. The needles will be taped so that the needles will never puncture the skin. The patients will then be given hydrocodone / acetaminophen 5mg/325mg (generic) with a prescription to take home and use as needed.
干预措施: hydrocodone / acetaminophen 5mg/325mg (Drug)
Standard Drug Plus Acupuncture Group
The participants in this group will receive auricular acupuncture following the Battlefield Acupuncture Protocol. The patients will then be given hydrocodone / acetaminophen 5mg/325mg (generic) with a prescription to take home and use as needed (in the acupuncture groups, the physician administering the treatment will not know if the patient is receiving the standard drug or the placebo pill). The physician can administer up to 10 needles (5 in each ear) until the patient has a "significant" drop in pain (pain level 0 or 1).
干预措施: Auricular Acupuncture (Procedure)
Standard Drug Plus Acupuncture Group
The participants in this group will receive auricular acupuncture following the Battlefield Acupuncture Protocol. The patients will then be given hydrocodone / acetaminophen 5mg/325mg (generic) with a prescription to take home and use as needed (in the acupuncture groups, the physician administering the treatment will not know if the patient is receiving the standard drug or the placebo pill). The physician can administer up to 10 needles (5 in each ear) until the patient has a "significant" drop in pain (pain level 0 or 1).
干预措施: Acupuncture (Device)
Standard Drug Plus Acupuncture Group
The participants in this group will receive auricular acupuncture following the Battlefield Acupuncture Protocol. The patients will then be given hydrocodone / acetaminophen 5mg/325mg (generic) with a prescription to take home and use as needed (in the acupuncture groups, the physician administering the treatment will not know if the patient is receiving the standard drug or the placebo pill). The physician can administer up to 10 needles (5 in each ear) until the patient has a "significant" drop in pain (pain level 0 or 1).
干预措施: hydrocodone / acetaminophen 5mg/325mg (Drug)
Acupuncture Group
The participants in this group will receive auricular acupuncture following the Battlefield Acupuncture Protocol. The physician can administer up to 10 needles (5 in each ear) until the patient has a "significant" drop in pain (pain level 0 or 1). The patient will then be given a placebo pill.
干预措施: Auricular Acupuncture (Procedure)
Acupuncture Group
The participants in this group will receive auricular acupuncture following the Battlefield Acupuncture Protocol. The physician can administer up to 10 needles (5 in each ear) until the patient has a "significant" drop in pain (pain level 0 or 1). The patient will then be given a placebo pill.
干预措施: Acupuncture (Device)
Acupuncture Group
The participants in this group will receive auricular acupuncture following the Battlefield Acupuncture Protocol. The physician can administer up to 10 needles (5 in each ear) until the patient has a "significant" drop in pain (pain level 0 or 1). The patient will then be given a placebo pill.
干预措施: Placebo Pill (Drug)
结局指标
主要结局
Pain Intensity Measure (VAS score 0-10)
时间窗: 48 hours
Measurement of patient's pain level over 48 hours (VAS score 0-10)
次要结局
- Recurrence of Pain (VAS score 0-10)(48 hours)
- Past Trauma History(48 hours)
- Medication Usage(48 hours)
研究者
Traci Marin
Assistant Professor - Research Scientist
Loma Linda University