The Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone Following Shoulder Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Worst overall pain assessed by Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this randomized clinical trial is to determine the effectiveness of Battlefield Acupuncture (BFA) in addition to standard post-surgical shoulder physical therapy compared to a standard shoulder rehabilitation program in reducing medication use and pain in patients who have undergone shoulder surgery. Measurements of medication (opioid, NSAID, acetaminophen, etc.) use (daily number of pills consumed), pain rating, patient specific functional scale and global rating of change will be taken at 48-hours (baseline), 72-hours, 1-week, and 4-weeks post-surgery. It is hypothesized that the inclusion of Battlefield Acupuncture will result in a decrease in post-surgical pain levels, reduced opioid medication use, and improved patient mood when compared to rehabilitation alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 17-55 Department of Defense beneficiaries (17 only if an emancipated cadet at the U.S. Military Academy)
- •Prior to or within 48 hours post shoulder stabilization surgery
- •Prior to or within 48 hours post rotator cuff repair surgery
排除标准
- •Self-reported pregnancy
- •History of blood borne pathogens, infectious disease, or active infection
- •History of metal allergy
- •History of bleeding disorders or currently taking anti-coagulant medications
- •Participants who are not fluent in English
结局指标
主要结局
Worst overall pain assessed by Visual Analogue Scale (VAS)
时间窗: 72 hours, 1 week
Worst pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
Average 24-hour pain assessed by Visual Analogue Scale (VAS)
时间窗: 72 hours, 1 week
Average pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
次要结局
- Medication Use(1 week, 4 weeks)
- Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS)(4 weeks)
- Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire(72 hours, 1 week, 4 weeks)
研究者
Michael Crowell
Director & Associate Professor
Keller Army Community Hospital