Pulsed Electromagnetic Fields for Postoperative and Post-Amputation Analgesia: A Randomized, Participant- and Observer-Masked, Sham-Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pain Measured With the Numeric Rating Scale
研究概览
简要总结
Pulsed shortwave (radiofrequency) therapy is a possible method of pain control involving the application of electromagnetic energy (also termed pulsed electromagnetic fields). Food and Drug Administration-cleared devices have been in clinical use for over 70 years. For decades, available devices consisted of a large signal generator and bulky coil applicator that were not portable and produced significant electromagnetic interference, making them impractical for common use. However, small, lightweight, relatively inexpensive, noninvasive, Food and Drug Administration-cleared devices that function for 8 days are now available to treat acute and chronic pain, decrease inflammation and edema, and hasten wound healing and bone regeneration. Therefore, it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements, only without the limitations of opioids and peripheral nerve blocks. The purpose of this study is to explore the possibility of treating acute postoperative pain with nonthermal, pulsed shortwave (radiofrequency) therapy, optimize the study protocol, and estimate the treatment effect.
详细描述
The proposed study will be a randomized, participant- and observer-masked, sham-controlled, parallel-arm, human participants study with two primary aims:
Specific Aim 1: To determine the feasibility and optimize the protocol for subsequent clinical trials that will compare the addition of nonthermal, pulsed shortwave therapy to usual and customary analgesia following moderate-to-severely painful surgical procedures.
Specific Aim 2: To estimate the treatment effect of adding nonthermal, pulsed shortwave therapy to usual and customary analgesia on pain and opioid consumption following moderate-to-severely painful surgical procedures.
Hypothesis 1 (primary): Nonthermal, pulsed shortwave therapy decreases pain in the 7 days following moderate-to-severely painful surgical procedures.
Hypothesis 2: Nonthermal, pulsed shortwave therapy decreases opioid use in the 7 days following moderate-to-severely painful surgical procedures.
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 (Participant, Investigator, Outcomes Assessor)
盲法说明
The Investigational Drug Service will create the randomization tables and provide the investigators with the appropriate device (active or sham), leaving all participants, investigators, and the statistician masked to treatment group assignment with the exception of the study coordinator who receives the study device from the Investigational Drug Service.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •concurrent use of an implanted pulse generator (e.g., cardiac pacemaker)
- •pregnancy
- •incarceration
- •chronic opioid/tramadol use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
- •neuro-muscular deficit of the surgical area/limb
- •a planned postoperative perineural local anesthetic infusion
结局指标
主要结局
Pain Measured With the Numeric Rating Scale
时间窗: First postoperative week
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The primary outcome calculated as follows: for each participant all of the "average" and "worst" daily pain scores collected within the first 7 postoperative days will be summed: specifically on Days 1, 2, 3, and 7, resulting in a scale of 0-80.
次要结局
- AVERAGE Pain Measured With the Numeric Rating Scale(postoperative day 180)
- Median AVERAGE Pain Measured With the Numeric Rating Scale(Median value of the average daily pain measured on postoperative days 1, 2, 3, and 7)
- Median WORST Pain Measured With the Numeric Rating Scale(Median value of the worst daily pain measured on postoperative days 1, 2, 3, and 7)
- WORST Pain Measured With the Numeric Rating Scale(postoperative day 180)
- LEAST Pain Measured With the Numeric Rating Scale(postoperative day 14)
- CURRENT Pain Measured With the Numeric Rating Scale(postoperative day 14)
- Total OPIOID Consumption for Postoperative Days 1, 2, 3, and 7 (Measured in Oral Oxycodone Equivalents)(Cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7)
- Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)(postoperative day 180)
- Brief Pain Inventory, Short Form (Interference Subscale)(postoperative day 14)
- Awakenings Due to Pain(postoperative day 14)
- Hospitalization Duration Measured in Days(First postoperative week)
- Surgical Duration(intraoperative (within the operating room))
- Device Location Changes(postoperative day 14)
- Passive Joint Flexion(postoperative day 14)
研究者
Brian M. Ilfeld, MD, MS
Professor of Anesthesiology, In Residence
University of California, San Diego