Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- AVERAGE Pain Measured With the Numeric Rating Scale
研究概览
简要总结
Pulsed electromagnetic field therapy is a possible method of pain control involving the application of electromagnetic energy (also termed nonthermal, pulsed, shortwave radiofrequency therapy). 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 30 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 pilot 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 in preparation for developing subsequent definitive clinical trials.
详细描述
The proposed study will be a randomized, participant- and observer-masked, sham-controlled, parallel-arm, human participants pilot 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. This will provide an idea of the optimal surgical procedures amenable to this analgesic technique and allow determination of the required sample sizes of subsequent definitive clinical trials.
Hypothesis 1: 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
- Quadruple (Participant, Care Provider, 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.
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
- •Adult patients of at least 18 years of age undergoing one of these primary surgical procedures:
- •non-mastectomy breast surgery with a single-injection paravertebral nerve block
- •laparoscopic cholecystectomy
- •laparoscopic sleeve gastrectomy
- •percutaneous nephrolithotomy
- •ventral hernia repair
- •inguinal hernia repair
- •knee or hip arthroplasty
- •foot/ankle surgery with at least moderate pain anticipated
- •shoulder acromioclavicular joint repair, labral repair, subacromial decompression, or Bankart repair (without rotator cuff repair)
- •hand/forearm/elbow surgery with at least moderate pain anticipated
- •spinal surgery with at least moderate pain anticipated
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
AVERAGE Pain Measured With the Numeric Rating Scale
时间窗: Mean value of the average daily pain measured on postoperative days 1, 2, 3, and 7
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily average pain scores measured with the Numeric Rating Scale
WORST Pain Measured With the Numeric Rating Scale
时间窗: Mean value of the worst daily pain measured on postoperative days 1, 2, 3, and 7
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily worst pain scores measured with the Numeric Rating Scale
Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 7 (Measured in Oral Oxycodone Equivalents)
时间窗: Cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7
Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 7 (measured in oral oxycodone equivalents).
次要结局
- Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)(postoperative day 180)
- LEAST Pain Measured With the Numeric Rating Scale(postoperative day 28)
- CURRENT Pain Measured With the Numeric Rating Scale(postoperative day 28)
- Awakenings Due to Pain(postoperative day 28)
- AVERAGE Pain Measured With the Numeric Rating Scale(postoperative day 180)
- WORST Pain Measured With the Numeric Rating Scale(postoperative day 180)
- Passive Flexion (Knee and Hip Arthroplasty Patients Only)(One measure take at the two-week postoperative check (approximately postoperative day 14))
- Day Stopped Using Intervention(One single measure recorded following the day of surgery)
- Brief Pain Inventory, Short Form (Interference Subscale)(postoperative day 28)
- Desire Use of Device in Hypothetical Future Surgery?(queried on postoperative day 28)
- Surgical Stop as Recorded Using Military Time Format(Intraoperative (within the operating room))
- Hospitalization Duration Measured in Days(One single measure recorded on or following the day of surgery (whichever day patient is discharged))
- Surgical Start as Recorded Using Military Time Format(Intraoperative (within the operating room))
- Surgical Duration(Intraoperative (within the operating room))
- Device Location Changes(Postoperative day 28)
研究者
Brian M. Ilfeld, MD, MS
Professor Anesthesiology, In Residence
University of California, San Diego