Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 599
- 试验地点
- 2
- 主要终点
- Number of ED patients eligible for recruitment as measured by patient log
研究概览
简要总结
The purpose of this project is to determine the feasibility, acceptability and effectiveness of acupuncture in the Emergency Department (ED) for treating acute musculoskeletal pain. The overall goal is to reduce acute and subacute opioid use by improving acute pain, anxiety and disability with non-pharmacologic treatment options at a critical entry point for patients into the healthcare system. This full-scale randomized controlled trial (RCT) has been statistically powered to test the effectiveness of ED-based acupuncture for both one-hour (Stage 1) and one-month (Stage 2) pain reduction outcomes. The feasibility will be assessed based on patient recruitment and retention rates, while the acceptability will be assessed using patient reported outcomes and qualitative semi-structured interviews.
Stage 1 is a 2-phase study design. Phase (1): Enrolled subjects will be randomized to auricular (ear) acupuncture, peripheral acupuncture, or the control group receiving no acupuncture. Subjects assigned to an acupuncture arm will receive information and access to acupuncture in an outpatient clinic for the 4 weeks following ED visit. Subjects may also have a blood draw for biomarker analysis during their ED visit. A planned interim analysis of the first 60 patients (2/3 of the Phase 1 arm completed) will be completed to select the more effective and/or acceptable arm for Phase 2. At interim analysis, it was determined by the DSMB that neither arm was superior, so the recommendation was to continue Stage 1 Phase 2 unchanged with 3 arms. Stage 1 is complete, and we will proceed with Stage 2 powered to the 4-week pain score outcome. Stage 2 will proceed with the same procedures as stage 1, only powered to a different outcome.
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
- Triple (Care Provider, Investigator, 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
- 是
入选标准
- •Adults age 18 or older
- •Clinical diagnosis of acute (≤7 days) musculoskeletal pain as determined by an ED provider
- •Able to read and understand the consent form in English
排除标准
- •Unable to receive acupuncture due to injury or infection of acupuncture sites
- •Unwilling or unable to attend the follow-up outpatient acupuncture clinic
- •Severe hearing or speech impairment
- •Cognitive impairment, including evidence of drug, medication or alcohol intoxication, that would prevent comprehension of consent procedures or study measures and procedures
- •Critical illness
- •Deformity
- •Medical condition that would contraindicate safe participation as determine by an ED provider
研究组 & 干预措施
Auricular (Battlefield) Acupuncture
Auricular acupuncture involves placement of needles based on battlefield acupuncture protocol which involves the placement of needles in up to 5 sites on each ear to treat pain.
干预措施: Auricular (Battlefield) Acupuncture (Procedure)
Peripheral Acupuncture
Peripheral acupuncture involves placement of needles in up to 30 specific sites in the head, neck, arms from the shoulders to the hands, and legs from the knees to the feet
干预措施: Peripheral Acupuncture (Procedure)
Control
Standard of care without acupuncture
结局指标
主要结局
Number of ED patients eligible for recruitment as measured by patient log
时间窗: Post implementation, up to 6 weeks
Number of patients enrolled as measured by patient log
时间窗: Post implementation, up to 6 weeks
Number of patients that found acupuncture satisfactory via satisfactory questionnaire
时间窗: Post implementation, up to 6 weeks
Likert-scale, agree disagree
Number of adverse events
时间窗: Post implementation, up to 2 weeks
Number of outpatient acupuncture sessions attended
时间窗: 4 weeks post discharge
Change in Pain Score
时间窗: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
11-point Numeric Rating Scale (NRS) for current pain
Number of patients retained in study as measured by patient log
时间窗: Post implementation, up to 6 weeks
次要结局
- Change in function(ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge)
- Change in cognitive function(ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge)
- Number of return ED visits(Up to one year post ED visit)
- Pain medications received(Up to three months post ED visit)
- Time in minutes for ED based acupuncture session(Post ED acupuncture session, up to 1 hour)