Pain Neuroscience Education and Physical Exercise Program in Patients With Chronic Back Pain. Intervention From Primary Care Physiotherapy Units
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Change in Health-related Quality of Life at different time points
研究概览
简要总结
This study evaluates the effects of a pain neuroscience education (PNE) and physical exercise (PE) program in patients with chronic back pain. Half of participants receive PNE and PE program supervised by a physiotherapist and the other half receive usual physiotherapy care supported by physiotherapy protocols in primary care.
详细描述
Justification: Chronic musculoskeletal pain (CMP) affects more than 20% of the population, its prevalence is increasing, generating suffering and high health expenditure. The current knowledge of neurophysiology of pain shows that the painful experience in CMP is not necessarily associated with peripheral tissue damage and is due more to an alteration of central mechanisms of pain processing and to the dysfunction of endogenous pain inhibitory mechanisms. Physical exercise (PE) has been shown to be effective in CMP. Pain neuroscience education (PNE) improves the levels of pain catastrophism, Kinesiophobia, quality of life, disability and also modifies maladaptive cognitions that favour a painful response.
Objectives: To evaluate the efficacy of a PNE and PE in patients with chronic back pain (CBP). Changes in pain intensity, pain thresholds, Catastrophism, kinesiophobia, disability, central sensitization and quality of are measured.
Material and methods
Multicenter randomized clinical trial (RCT) with 170 patients. Intervention group receive 6 sessions of PNE and a 6 weeks PE program (18 sessions) aimed at improving functional capacity, neurogenesis and cerebral plasticity. Control group receive usual physiotherapy treatment (supported by the current protocols in Primary Care in the Health System of Castilla y León). The outcome variables are measured by Visual Analog Scale (EVA), Pressure Pain Threshold (PPT), Kinesiophobia Tampa Scale (TKS-11), Central Sensitization Questionnaire (CSC), Pain Catastrophism Questionnaire (CCD), disability (Roland-Morris), Quality of life (SF-36) and satisfaction (CSQ-8). An initial assessment, post-intervention (week 10), at six months and at year is performed. Patients Evaluator and Outcomes Assessor are masked.
Applicability of results: The proposed intervention is simple and reproducible. It can be performed in the Primary Care Physiotherapy Units. It requires few resources, and it can produce changes in pain intensity, functionality and quality of life of patients with CBP
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
Patients Evaluator and Outcomes Assessor are masked
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonspecific back pain of at least 6 months.
- •Accept to participate in the study and sign the informed consent.
排除标准
- •Oncological pain.
- •Spine fracture or surgical intervention in last year.
- •Neurological cognitive alteration that prevents understanding the contents of PNE program (In case of doubt, assesment with Minimental test)
- •Motor control alteration that prevents the execution of the planned PE program (Minimum requirement: execution in normal time of the Timed Up and Go test)
- •Pregnancy.
- •Bladder or bowel incontinence.
- •Saddle anesthesia.
- •Patients presenting other clinical conditions that may aggravate chronic spinal pain (chronic fatigue syndrome, fibromyalgia and complex regional pain syndrome).
- •Patients with associated pathologies that make it impossible to perform physical exercise program.
- •Patients under treatment with alternative therapies.
结局指标
主要结局
Change in Health-related Quality of Life at different time points
时间窗: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) V2. Spanish version. The SF-36 is a 36-item scale constructed to survey health status and quality of life. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary. Each scale is directly transformed into a 0-100 scale. Higher scores indicate better overall quality of life.
次要结局
- Pressure pain threshold.(Change from baseline to post-treatment, to 6 months and at 12 months follow-up)
- Change in Pain Catastrophism at different time points(Change from baseline to post-treatment, to 6 months and at 12 months follow-up)
- Change in Kinesiophobia at different time points(Change from baseline to post-treatment, to 6 months and at 12 months follow-up)
- Satisfaction survey. Satisfaction with the treatment(at 10 weeks)
- Change in Pain assessment at different time points(Change from baseline to post-treatment, to 6 months and at 12 months follow-up)
- Change in Disability at different time points(Change from baseline to post-treatment, to 6 months and at 12 months follow-up)
- Modifications of body mass index.(Change from baseline to post-treatment, to 6 months and at 12 months follow-up)
- Change in Central sensitization levels at different time points(Change from baseline to post-treatment, to 6 months and at 12 months follow-up)
- Change in Drugs consumption(Change from baseline to post-treatment, to 6 months and at 12 months follow-up)