The Clinical Effect of Pregabalin on Neuropathic Pain in Central Sensitized Patients Who Are Treated With Duloxetine After Total Knee Arthroplasty: Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Visual Pain Scale change
研究概览
简要总结
In this study, patients scheduled to undergo total knee arthroplasty (TKA) will be screened through a survey for patients with central sensitivity and patients with neuropathic pain as preoperative evaluation.
It is designed to evaluate the effectiveness of pregabalin with the decision to prescribe duloxetine by dividing patient groups according to central sensitization and neuropathic pain.
详细描述
Screening for central sensitization and neuropathic pain will be performed two weeks in advance of surgery for patients scheduled to undergo total knee arthroplasty, and is performed through a central sensitization questionnaire and neuropathic pain survey. Through the Central Sensitization Inventory, if the score is 40 or higher out of 100 points, it is considered as the subject of central sensitization. And 13 or higher based on 38 points are considered as the subject of neuropathic pain.
Among the patients who meet these two criteria, only those who agree to the study are targeted. The same probability is assigned by a randomized table two weeks before surgery to a group taking duloxetine and pregabalin and a group taking only duloxetine.
In the case of patients with central sensitization and neuropathic pain, both the experimental group and the control group will take medicine for 10 weeks from 2 weeks before surgery to 8 weeks after surgery. The experimental group takes one pill of duloxetine 30 mg, one pill of pregabalin 150mg after breakfast and one pill of pregabalin 150 mg after dinner. The control group takes only one pill of duloxetine 30 mg after breakfast.
A total of 10 weeks' worth of drugs will be provided two weeks before surgery, and medication compliance will be evaluated based on the number of unused drugs returned by the test subject when the drug is returned. In order to evaluate medication compliance, clinical trials should record the number of drugs provided and returned at each visit and the discontinuation date. Subjects must receive medication guidance on the drug-taking schedule. When the clinical trial is completed or terminated in the middle, the unused or partially used drugs must be returned to the clinical examiner and discarded after confirmation.
Relief drugs can also be taken up to six tablets a day, up to two tablets of 650 mg of Tylenol ER Tablets(acetaminophen) once in both groups.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for total knee arthroplasty over the age of 19
- •Patients who have the will or ability to follow the doctor's instructions, including rehabilitation treatment such as joint exercise.
- •Patients understand this study and agree in writing by the patient's own or by the patient's representative to participate in the study.
- •Patients with central sensitization and neuropathic pain.
排除标准
- •Rheumatoid arthritis
- •Other inflammatory arthritis
- •Neuropsychiatric patients
- •Hepatic insufficiency
- •Renal insufficiency
- •Allergy or intolerance to study medications
- •Patients with an acetylsalicylic acid of IV (angina, congestive heart failure, dementia, cerebrovascular accident)
- •Chronic gabapentin or pregabalin use (regular use for longer than 3 months)
- •Chronic opioid use (taking opioids for longer than 3 months)
- •Alcohol, drug abuser
- •Narcotics addiction
研究组 & 干预措施
Experimental: Duloxetine and Pregabalin
Experimental group will take medicine for 10 weeks from 2 weeks before surgery to 8 weeks after surgery. The group takes one pill of duloxetine 30 mg, one pill of pregabalin 150mg after breakfast and one pill of pregabalin 150 mg after dinner.
干预措施: Duloxetine 30mg (Drug)
Experimental: Duloxetine and Pregabalin
Experimental group will take medicine for 10 weeks from 2 weeks before surgery to 8 weeks after surgery. The group takes one pill of duloxetine 30 mg, one pill of pregabalin 150mg after breakfast and one pill of pregabalin 150 mg after dinner.
干预措施: Pregabalin 150mg (Drug)
Active Comparator: Duloxetine
Active comparator group will take medicine for 10 weeks from 2 weeks before surgery to 8 weeks after surgery. The group takes only one pill of duloxetine 30 mg after breakfast.
干预措施: Duloxetine 30mg (Drug)
结局指标
主要结局
Visual Pain Scale change
时间窗: Changes from preoperative Visual pain scale at postoperative 1,2,6,18 weeks and 1 year
Visual pain scale is a validated questionnaire for evaluation of patients who underwent knee operation. The score range is 0-10. The lower the score, the better the result.
次要结局
- Western Ontario and McMaster University Arthritis Index Scale change(Changes from preoperative Western Ontario and McMaster University Arthritis Index (WOMAC) scale at postoperative 1, 2, 6, 18 weeks and 1 year)
- Knee range of motion change(Changes from preoperative knee range of motion at postoperative 1, 2, 6, 18 weeks and 1 year)
研究者
Yong In
Professor
The Catholic University of Korea