Utilization of a Microcurrent Device for Postoperative Pain Following Functional Endoscopic Sinus Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Pain Visual Analog Score After First Use of Device
研究概览
简要总结
The purpose of this study is to investigate whether daily use of a microcurrent neuromodulation device, which applies a small current of electricity to the forehead and maxillary region, will decrease the pain experienced by patients in the days following functional endoscopic sinus surgery (FESS). This study is a prospective randomized controlled study. Enrolled subjects will be randomized (1:1) to receive either an active neuromodulation study device or a sham device that appears identical to the active device while emitting no therapeutic microcurrent. Subjects will self-treat with the device at home and will be followed for 2 weeks after FESS.
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 participant and all study staff will be blinded to which device they are receiving, either the study device or the identical sham device. Devices will be labeled A or B, with only the device manufacturer knowing which device is the active study device and which is the sham.
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
- •Scheduled for FESS functional nasal or endoscopic sinus surgery
- •Possessing an American Society of Anesthesiologists physical status classification of I or II
- •Possess the capacity to give informed consent
- •Able to read, write and understand English or Spanish
- •Able to attend follow up visits at postop days 7 and 14 Visit 1 (within 0 - day 14) and post-op Visit 2 (within 10 - 21 days)
- •Postop pain VAS ≥ 5 in PACU phase II
排除标准
- •Age < 18
- •Does not understand English or Spanish
- •Does not meet inclusion criteria
- •History of chronic pain
- •Experiencing chronic pain requiring opioids at baseline and/or who are under the care of pain management specialists
- •Neurologic disorders (including seizure disorders)
- •Undergoing planned or unplanned additional procedures at the time of FESS surgery
- •In custody of the state
- •Prisoners
- •Known to be pregnant
- •Implanted cranial metallic components or devices including deep brain stimulators or cochlear implants
- •Has an implanted or external worn cardiac device including pacemakers, automated implantable cardioverter defibrillator (AICD), or any other cardiac electric devices (including non-implanted devices, e.g. defibrillator vest)
结局指标
主要结局
Change in Pain Visual Analog Score After First Use of Device
时间窗: baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure
Change in postoperative pain score in first use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the first time they use the device.
Change in Pain Visual Analog Score After Second Use of Device
时间窗: baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure
Change in postoperative pain score after second use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the second time they use the device.
Change in Pain Visual Analog Score After Third Use of Device
时间窗: baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure
Change in postoperative pain score after third use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the third time they use the device.
Change in Pain Visual Analog Score After Fourth Use of Device
时间窗: baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure
Change in postoperative pain score after fourth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fourth time they use the device.
Change in Pain Visual Analog Score After Fifth Use of Device
时间窗: baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure
Change in postoperative pain score after fifth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fifth time they use the device.
Sino-Nasal Outcome Test (SNOT 22)
时间窗: Baseline and 2 weeks Post-Op
The possible range of Total SNOT scores is between 0 to 110. Higher scores indicate greater rhinosinusitis-related health burden.
Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score
时间窗: Baseline and 2 weeks Post-Op
Full scale from 0-100. Higher score indicates more severe symptoms
次要结局
- Debridement Associated Pain Visual Analog Score After Third Use of Device(baseline, 10 min, 2 hour, 4 hour on POD14)
- Debridement Associated Pain Visual Analog Score After Fourth Use of Device(baseline, 10 min, 2 hour, 4 hour on POD14)
- Debridement Associated Pain Visual Analog Score After First Use of Device(baseline, 10 min, 2 hour, 4 hour on POD14)
- Postoperative Pain Medication Usage(Daily until 2nd postoperative visit (day 14))
- Debridement Associated Pain Visual Analog Score Before Use of Device(baseline, 10 min, 2 hour, 4 hour on POD14)
- Debridement Associated Pain Visual Analog Score After Second Use of Device(baseline, 10 min, 2 hour, 4 hour on POD14)
研究者
Alfred-Marc Iloreta
Assistant Professor
Icahn School of Medicine at Mount Sinai