Physical Therapy for the Management of Postoperative Pain After Minimally Invasive Thoracic Surgery
To evaluate the effectiveness of a protocolized physical therapy program in reducing postoperative chest and abdominal wall pain after minimally invasive thoracic surgery. To characterize neuropathic and nociceptive components of post-thoracotomy pain using the Perioperative Neuropathic Pain Assessment Form
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Luismiguel Cotamo, Research Assistant
- 电话号码：305-689-3366
- 邮箱：lxc332@miami.edu
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Are ≥18 years old
- Undergo minimally invasive lung surgery including Video assisted thoracic surgery (VAST) and Robotic assisted thoracic surgery (RATS)
- Wedge resection
- Segmentectomy
- Lobectomy
- Pneumonectomy
- Present to the 2-week postoperative clinic visit
- Report pain score ≥4 on the Numeric Rating Scale
- Can participate in physical therapy at the University of Miami (UM) downtown facility
Exclusion Criteria:
- Undergo esophagectomy
- Undergo mediastinal or thymic resection procedures
- Are unable to participate in physical therapy due to severe medical comorbidities or geographical limitations
- Have cognitive impairment preventing participation in assessments
- Decline participation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Physical Therapy + Standard of Care Analgesia Therapy Group
Participants will receive standard postoperative analgesic therapy per routine clinical care throughout the study period. In addition, participants will complete protocolized physical therapy consisting of 1 session per week for 4 weeks, beginning at postoperative week 4. Total participation in this arm is approximately 6 months |
Protocolized physical therapy administered once weekly for 4 weeks beginning at postoperative week 4. Therapy includes chest wall strengthening, shoulder girdle mobilization, postural training, abdominal strengthening, inspiratory muscle training, and pain management modalities (cryotherapy, moist heat, ultrasound). Postoperative analgesic therapy administered as part of routine clinical standard of care and determined by the treating physician. Medications may include acetaminophen (Tylenol), celecoxib (Celebrex), ibuprofen (Advil), ketorolac (Toradol), gabapentin (Neurontin), and oxycodone (OxyContin). Dosing, frequency, and duration will be individualized based on patient need and determined by the treating clinician. |
|
有源比较器：Standard Care Analgesia Therapy Group
Participants will receive standard postoperative analgesic therapy per routine clinical care throughout the study period. Total participation in this arm is approximately 6 months. |
Postoperative analgesic therapy administered as part of routine clinical standard of care and determined by the treating physician. Medications may include acetaminophen (Tylenol), celecoxib (Celebrex), ibuprofen (Advil), ketorolac (Toradol), gabapentin (Neurontin), and oxycodone (OxyContin). Dosing, frequency, and duration will be individualized based on patient need and determined by the treating clinician. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Postoperative Pain Intensity
大体时间：Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively
|
Pain intensity will be measured using the Numeric Rating Scale (NRS), a patient-reported scale ranging from 0 (no pain) to 10 (worst possible pain). Time Frame: Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively |
Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively
|
|
Change in Neuropathic Pain Score
大体时间：Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively
|
Neuropathic pain will be measured using the DN4 (Douleur Neuropathique en 4 Questions) questionnaire, with total scores ranging from 0 to 10. A score of ≥4 indicates the presence of neuropathic pain. |
Baseline (2 weeks postoperatively), 8 weeks, and 6 months postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative Opioid Exposure
大体时间：8 weeks, and 6 months postoperatively
|
Cumulative opioid exposure, calculated as the total morphine milligram equivalents (MME) of opioid medications used during the assessment periods |
8 weeks, and 6 months postoperatively
|
合作者和调查者
调查人员
- 首席研究员：Diego Avella-Patino, MD、University of Miami
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.