Investigation of the Efficacy of Neuroscience Pain Education in Patients With Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pain severity change is being assessed
研究概览
简要总结
The aim of Pain Neuroscience Education (PNE) is to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. PNE provides compelling evidence in reducing pain, disability, pain catastrophization, and limited physical movement in musculoskeletal problems. Knee osteoarthritis (KOA) is a very common painful musculoskeletal problem, especially in people over 50 years old, and lead to decrease in knee range of motion. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, poor outcomes are common. The lack of satisfactory results suggests that some practices should be revised. Although PNE could be useful as an intervention, to our knowledge, there is no randomized controlled trial in the literature investigating the effects of PNE in patients with a KOA. Therefore, we aimed to examine the effectiveness of PNE on clinical outcomes in patients with KOA.
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
- Single (Outcomes Assessor)
盲法说明
the blinded assessor
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a body mass index between 19-40 kg/m2,
- •Having had a unilateral TKA,
- •Knee pain score to be 4 and above daily according to the visual analog scale,
- •Ability to read, speak and understand Turkish.
排除标准
- •Prosthesis disorders requiring re-surgery,
- •Having visual, auditory and cognitive impairment,
- •Secondary TKA such as rheumatoid arthritis,
- •Acute pain,
- •Pregnancy, drug and alcohol use,
- •Having bilateral TKA,
- •Not volunteering to participate in the study
结局指标
主要结局
Pain severity change is being assessed
时间窗: 6 week
Visual Analogue Scale (0-10, higher means worse)
Pain severity
时间窗: Baseline
Visual Analogue Scale (0-10, higher means worse)
Pain and Function change are being assessed
时间窗: 6 week
Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)
Pain and Function
时间窗: Baseline
Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)
次要结局
- Pain Catastrophizing change is being assessed(6 week)
- Kinesiophobia change is being assessed(6 week)
- Level of quality of life(Baseline)
- Level of quality of life change is being assessed(6 week)
- Pain Catastrophizing(Baseline)
- Anxiety and Depression(Baseline)
- Anxiety and Depression change is being assessed(6 week)
- Kinesiophobia(Baseline)
- Physical Function(Baseline)
- Physical Function change is being assessed(6 week)
研究者
Abdulhamit Tayfur
Principal Investigator
Ahi Evran University Education and Research Hospital