Feasibility, Acceptability, and Preliminary Efficacy of Combined Transcranial Direct Current Stimulation and Mindfulness for Pain After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Analgesic Consumption
研究概览
简要总结
Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty
详细描述
The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) undergoing TKR. And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective unilateral knee total replacement
- •mentally capable of reading, giving consent and following instructions
- •being able to answer questions in English
- •not pregnant
排除标准
- •history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
- •systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
- •alcohol/substance abuse
- •current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
- •hospitalization within the preceding year for psychiatric illness
- •no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
结局指标
主要结局
Analgesic Consumption
时间窗: day 3 after surgery
The dose of every opioid received within 3 days postoperatively will be transcribed and converted into standardized parenteral morphine equivalents using the Centers for Disease and Control Prevention Guidelines on opioids. A total in milligrams will be calculated for each day and means will be obtained for all groups.
次要结局
- Brief Pain Inventory (BPI)(day 3 after surgery)
- Patient Health Questionnaire-4 (PHQ-4)(day 3 after surgery)
- Pain Catastrophizing Scale (PCS)(day 3 after surgery)
- Numerical Rating Scale (NRS)(day 3 after surgery)
- Brief Pain Inventory (BPI)(day 3 after surgery)
- Patient Health Questionnaire-4 (PHQ-4)(day 3 after surgery)
- Pain Catastrophizing Scale (PCS)(day 3 after surgery)
研究者
Geraldine Martorella
Principal Investigator
Florida State University