A Randomized Clinical Trial of Preoperative Pain Neuroscience Education for Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
To determine if education about pain given prior to Knee Arthroplasty will result in better outcomes following surgery
详细描述
To determine if a preoperative pain neuroscience education (PNE) program would result in superior outcomes compared to usual preoperative education for total knee arthroplasty (TKA). Patients will receive traditional hospital preoperative TKA program (usual care group) or receive the same program plus an additional 30-minute PNE program (experimental group). Pre and post measurements at 1, 3 and 6 months for pain, function, fear of movement and pain catastrophization. We will also compare opioid usage, healthcare expenses and patient satisfaction between 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Outcome measures were mailed by patients in prepaid envelopes
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
- •be scheduled to have a TKA and their standard preoperative TKA education program, indicate their willingness to participate in the study, ability to read and understand English, as the study included the use of an educational booklet, and be able and willing to complete outcome data for 6 months after TKA
排除标准
- •Because all potential participants for this study had been screened and cleared for their orthopedic surgery, the only exclusion criterion was an unwillingness to participate in the study and having had a previous TKA or scheduled for a bilateral TKA.
研究组 & 干预措施
Usual education control group (CG)
The CG received the traditional hospital preoperative program, which was consistent with current preoperative TKA protocols. The CG received education covering anatomy of the knee joint, information about the joint replacement surgery, what to expect when they were admitted for surgery, what to expect immediately after surgery, pain medications, postoperative rehabilitation/physical therapy, etc. The CG received a hospital-based booklet with this information.
干预措施: Pain Neuroscience Education (Behavioral)
Experimental group (EG)
The EG underwent an additional 30-minute group PNE program, followed by the usual preoperative education program from the hospital. The PNE program used in this TKA study was an adaptation of the PNE program developed for LS. The educational program was designed to be delivered by a physical therapist in a group session to patients prior to their TKA.
干预措施: Pain Neuroscience Education (Behavioral)
结局指标
主要结局
Pain
时间窗: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Numeric Pain Rating Scale
Function
时间窗: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Pain Catastrophization
时间窗: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Pain Catastrophization Scale
Fear of movement
时间窗: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Tampa Scale of Kinesiophobia
次要结局
- Opioid Use(Change at 1 month)
- Healthcare Expenses(Change from Baseline to 1 month, 3 months and 6 months post-surgery)
- Patient Satisfaction(Change at 1 month, 3 months and 6 months post-surgery)
研究者
Emilio J Puentedura, PT, DPT, PhD
Associate Professor
University of Nevada, Las Vegas