tDCS Combined With a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- postoperative opioid pain medication use
研究概览
简要总结
The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI).
This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles.
This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among Veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). The Veteran may benefit in the form of decreased pain and opioid requirements following knee or hip replacement surgery. However, benefit is only likely if Veterans are randomized to one of the 3 (out of 4) groups.
This study hopes to determine the effects of these interventions and combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.
详细描述
The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of tDCS, brief Cognitive-Behavioral (CB) intervention and their combination on pain among Veterans undergoing unilateral TKA or THA. 132 patients undergoing TKA/THA will be randomly assigned to one of four groups:
- Group1- real tDCS + real CB intervention
- Group2- real tDCS + education-only-control intervention
- Group3- sham tDCS + real CB intervention
- Group4- sham tDCS +education-only-control intervention
Participants will receive 2 tDCS/CBI treatments on the day of their surgery, and 2 tDCS/CBI treatments the day after their surgery. Participants' perioperative medication usage and pain ratings will be tracked during postoperative hospital stay. Follow-up data regarding pain and opioid use will be collected at 1, 3 and 6-months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be 120 patients (132 recruited to account for 10% drop-out rate) undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA) surgery at the Ralph H. Johnson VAMC in Charleston SC.
- •Mentally capable of reading, writing, giving consent, and following instructions
- •Cleared for, and scheduled for unilateral TKA or THA surgery
- •Able to hear Cognitive-Behavioral (CB) intervention and understand educational materials through headphones in English
排除标准
- •implanted medical devices above the waist
- •history of seizures
- •allergic to latex rubber
- •psychiatric conditions except for depression and/or anxiety disorders (commonly seen in this population)
研究组 & 干预措施
Group 1- real tDCS and real CBI
4 active treatments of tDCS and active cognitive behavioral intervention (CBI)
干预措施: Transcranial Direct Current Stimulation (Device)
Group 1- real tDCS and real CBI
4 active treatments of tDCS and active cognitive behavioral intervention (CBI)
干预措施: Cognitive-Behavioral (CB) intervention (Behavioral)
Group 3- sham tDCS and real CBI
4 sham treatments of tDCS and active cognitive behavioral intervention (CBI)
干预措施: Cognitive-Behavioral (CB) intervention (Behavioral)
Group 4- sham tDCS and sham CBI
4 sham treatments of tDCS and education-only-control cognitive intervention
干预措施: Transcranial Direct Current Stimulation (Device)
Group 4- sham tDCS and sham CBI
4 sham treatments of tDCS and education-only-control cognitive intervention
干预措施: Cognitive-Behavioral (CB) intervention (Behavioral)
Group 2- real tDCS and sham CBI
4 active treatments of tDCS and education-only-control cognitive intervention
干预措施: Transcranial Direct Current Stimulation (Device)
Group 2- real tDCS and sham CBI
4 active treatments of tDCS and education-only-control cognitive intervention
干预措施: Cognitive-Behavioral (CB) intervention (Behavioral)
Group 3- sham tDCS and real CBI
4 sham treatments of tDCS and active cognitive behavioral intervention (CBI)
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
postoperative opioid pain medication use
时间窗: 48 hours
Patient controlled analgesic medication usage (the morphine equivalent dose (MED); milligrams (mg) of morphine) during the acute 48-hour post-operative period following total knee arthroplasty (TKA) or total hip arthroplasty (THA).
次要结局
- Long term outcomes of patient reported pain ratings(6 months)