Physiotherapy and Therapeutic Education in Patients With Pain Catastrophizing After a Total Knee Arthroplasty. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Quality of life. Changes from Baseline to 6 months
研究概览
简要总结
The purpose of this study is to test whether adding a treatment using pain neuroscience education (PNE) and coping skills training (CST) to usual care, in subjects with knee osteoarthritis and pain catastrophizing, who are scheduled for a total knee arthroplasty (TKA), is more effective than only usual care. There is a high evidence level of different systematic reviews, which support the efficacy of physiotherapy treatments combined with behavioural techniques aimed to reduce pain catastrophism, pain and disability in other pathologies. The primary aim of that kind of interventions is to help the subjects to reconceptualise its own pain understanding and its role on the recovery process, as well as promoting an increase of activity and encourage the subject to resume its usual activity instead of continuing to avoid it.
详细描述
The prevalence of TKA has increased dramatically during the last two decades, its popularity can be attributed to its evident success regarding pain improvement, deformity correction and disability reduction in knee osteoarthritis subjects. However, only a third of the patients report no functional problems after surgery, the 20% of then are unsatisfied with its functional skills and around a 20% are experiencing pain, high disability degrees and a significant quality of life reduction. This results cannot be fully explained by mechanical processes, surgical procedures or surgery variations, but it seems to be related to other psychological aspects. Chronic pain subjects often develop maladaptative thoughts and behaviours (i.e. pain catastrophism, Kinesiophobia, activity avoidance) which contribute to make the subject suffer physically as well as emotionally, and affect on the intensity and persistency of pain.
Although many psychosocial factors have been studied, pain catastrophism has emerged as one of the most important predictors for persistent pain after a total knee arthroplasty, as well as its severity and duration, that's why it is getting more importance when it comes to study chronic pain in this subjects. Reducing pain catastrophism has become a key factor to determine the success in the rehabilitation of some maladies accompanied by pain, considering that its reduction has been associated with the clinical improvement of pain itself. It has been observed that treatments using psychological and psychosocial interventions, therapeutic education and coping skills training, or physical therapy and therapeutic exercise, are effective techniques to reduce pain catastrophism. Nevertheless, it's still necessary to determine whether the maladaptative pain related thoughts approach, using physical therapy and behavioural techniques, are able to reduce the risk of suffering postoperative chronic pain.
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)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have sufficient Spanish or Catalan reading, writing and speaking skills to comprehend all explanations and to complete the assessment tools.
- •Be able to provide the informed consent.
- •Be scheduled to undergo in a total knee arthroplasty.
- •Knee osteoarthritis diagnosis.
- •Score more than 16 points in the PCS.
- •Patients between 65-80 years.
排除标准
- •Patients scheduled to undergo in a total knee arthroplasty because of prostheses replacement, tumor, infection or fracture.
- •Patients scheduled to undergo in a bilateral total knee arthroplasty.
- •Patients that will need another total knee or hip replacement surgery in less than a year regarding the current intervention.
- •Patients scheduled for unicompartmental knee arthroplasty.
- •Patients with other pathologies with characteristic features of a central sensitization. (i.e. Fibromyalgia)
- •Co-existing other inflammatory or rheumatic conditions (i.e. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus or ankylosing spondylitis)
- •Co-existing other mental condition and/or major depression.
研究组 & 干预措施
Control Group: Usual Care
Procedure: Usual care The biomedical education session will be imparted 2 weeks before surgery by the preoperative nurse and a physiotherapist. It will have a duration of 2 hours and it is designed for a group of 5 subjects.
The hospital rehabilitation starts 6 hours after surgery, and it is based in early wandering stimulation, articular mobility exercises and isometric exercises.
干预措施: Usual care (Other)
Experimental: Usual Care + PNE and CST
Procedure: Usual care + PNE and CST. The PNE and CST program will be divided in 3 individual sessions. This program is mainly based in "Explain Pain" concept, used in multiple rehabilitation programs. Its aim is to change the subject's pain understanding, teaching them the biological processes underneath the pain construct, as a mechanism to reduce itself and its related maladaptative thoughts and behaviours
干预措施: Usual care (Other)
Experimental: Usual Care + PNE and CST
Procedure: Usual care + PNE and CST. The PNE and CST program will be divided in 3 individual sessions. This program is mainly based in "Explain Pain" concept, used in multiple rehabilitation programs. Its aim is to change the subject's pain understanding, teaching them the biological processes underneath the pain construct, as a mechanism to reduce itself and its related maladaptative thoughts and behaviours
干预措施: PNE + CST (Other)
结局指标
主要结局
Quality of life. Changes from Baseline to 6 months
时间窗: Baseline, 3 and 6 months after surgical intervention
Participants will be asked to complete the Euro Quality of Life (QoL) Score (EQ-5D) (Spanish version),
次要结局
- Disability / limitations(Baseline, 3 and 6 months after surgical intervention)
- Range of Motion(Baseline, 3 and 6 months after surgical intervention)
- Pain intensity(Baseline, 3 and 6 months after surgical intervention)
- Function(Baseline, 3 and 6 months after surgical intervention)
- Neuropathic Pain(Baseline, 3 and 6 months after surgical intervention)
- Pain Catastrophizing(Baseline, 3 and 6 months after surgical intervention)
- Kinesiophobia(Baseline, 3 and 6 months after surgical intervention)
- Self-efficacy(Baseline, 3 and 6 months after surgical intervention)
- Self-coping ability(Baseline, 3 and 6 months after surgical intervention)
- Depression and anxiety(Baseline, 3 and 6 months after surgical intervention)
研究者
Hector Beltran-Alacreu
PhD
Centro Universitario La Salle