Effect of Neuromuscular Exercise in Combination With Pain Neuroscience Education Compared to Pain Neuroscience Education Alone in Patients With Chronic Pain After Primary Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 5
- 主要终点
- Change in Knee Injury and Osteoarthritis Outcome Score4 (KOOS4) from baseline to 12months follow-up
研究概览
简要总结
The purpose of the study is to investigate whether a 12-week neuromuscular rehabilitation program (NEMEX-TJR) combined with pain neuroscience education (PNE) provides greater pain relief, improvement in physical function and quality of life than PNE alone in a population of patients with chronic pain after primary total knee arthroplasty.
Hypothesis: Rehabilitation involving neuromuscular training and PNE will provide greater pain relief, improved function and improved quality of life compared to PNE alone at the primary endpoint, which is follow-up 12months after the start of the treatment.
详细描述
Osteoarthritis is considered the most frequent cause of disability and pain in the elderly population, and the knee joint is one of the joints most commonly affected.
End-stage osteoarthritis is often treated with knee replacement, and total knee arthroplasty is considered an effective treatment for pain relief and improved function. However, several studies have reported less favorable outcomes after total knee arthroplasty, and systematic reviews found chronic pain after total knee arthroplasty at 12 months post-operative in 13-17% of the patients and chronic pain rates at 2-7 years post-operative varying between 8-27%. No randomized controlled trials evaluating exercise and pain education treatments to patients with chronic pain after total knee arthroplasty exists, and this highlights the need for evidence-based knowledge of which treatment should be considered for this population.
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
Outcome assessors will be blinded towards group allocation.
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
- •Body Mass Index (BMI) between 19-40
- •Subjects with primary total knee arthroplasty due to osteoarthritis ≥ 12 months post-operatively
- •For the index knee, duration of knee pain > 6 months
- •For the index knee, the average daily pain score ≥ 4 (moderate-to-severe pain) over the last week prior to visit on a numeric rating scale
排除标准
- •Specific reasons for chronic pain, such as loosening of implant, which requires revision surgery
- •Secondary causes of arthritis to the knee, e.g. rheumatoid arthritis
- •Surgery (including arthroscopy) of the index knee within 3 months prior to visit
- •Injury to the index knee within 12 months prior to visit
- •Recent history of acute pain affecting the lower limb and/or trunk
- •Participation in other pain trials two weeks prior to this study
- •Pregnancy
- •Drug and alcohol abuse
- •Previous neurologic illnesses or primary pain area other than knee, e.g. lower back, upper extremity pain or rheumatoid arthritis
- •Lack of ability to adhere to protocol
结局指标
主要结局
Change in Knee Injury and Osteoarthritis Outcome Score4 (KOOS4) from baseline to 12months follow-up
时间窗: Baseline and at 3, 6 and 12 months
The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be performed.
次要结局
- Change in PainDETECT scores(Baseline and at 3, 6 and 12 months)
- Change in dynamic mechanical allodynia at the index knee and extrasegmental(Baseline and at 3, 6 and 12 months)
- Change in pressure pain thresholds at the index knee and extrasegmental(Baseline and at 3, 6 and 12 months)
- Change in 40-meter fast-paced walk test(Baseline and at 3, 6 and 12 months)
- Change in score from the Pain Catastrophizing Scale(Baseline and at 3, 6 and 12 months)
- Change in deep somatic hyperalgesia at the index knee and extrasegmental(Baseline and at 3, 6 and 12 months)
- Change in descending pain control(Baseline and at 3, 6 and 12 months)
- Change in isometric muscle strength of knee extensors and flexors(Baseline and at 3, 6 and 12 months)
- Rating of Global Perceived Effect(3, 6 and 12 months)
- Change in use of Pain Medication(Baseline and at 3, 6 and 12 months)
- Change in 30-second chair stand test(Baseline and at 3, 6 and 12 months)
- Change in pinprick hyperalgesia at index knee and extrasegmental(Baseline and at 3, 6 and 12 months)
- Change in all five subscales of the KOOS(Baseline and at 3, 6 and 12 months)
- Change in maximal pain intensity during rest (day and night), stair climbing, and walking on a Numeric Rating Scale (NRS)(Baseline and at 3, 6 and 12 months)
- Change in temporal summation at index knee and extrasegmental(Baseline and at 3, 6 and 12 months)
- Change in number of sites with usual pain shaded on a body chart(Baseline and at 3, 6 and 12 months)
- Number of adverse events related to interventions(3 months)
- Change in stair climb test(Baseline and at 3, 6 and 12 months)
- Change in score from the Fear-avoidance Beliefs Questionnaire - Physical Activity(Baseline and at 3, 6 and 12 months)
- Change in leg extension power(Baseline and at 3, 6 and 12 months)
研究者
Jesper Bie Larsen
PhD-student
Aalborg University