Effects of Pain Neuroscience Education Compared to Self-Management Education for Patients With Chronic Low Back Pain: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain catastrophizing - Pain Catastrophizing Scale
研究概览
简要总结
Chronic low back pain interventions may include exercises, manual therapy, health education, and pain education, strategies based on psychological or behavioral change approaches, as well as biopsychosocial interventions. Pain self-management programs basically aim to engage the participant in activities, stimulating the patient to be more active in life and live despite the pain. However, pain neuroscience education is a new approach recognized as therapeutic patient education (ETP) and is best described as a form of cognitive rather than behavioral therapy. However, there are few studies in the literature comparing those types pain education. Thus, the purpose of this study will be to compare the immediate effects of an educational program focused on Pain Neuroscience Education vs. Pain self-management educations for patients with chronic low back pain considering the outcomes of pain intensity, catastrophizing and pain self-efficacy.
详细描述
There is some evidence in the literature suggesting better effects of pain neuroscience than "traditional pain education" based on pain self-management ("living despite the pain") and biomedical models. As the focus is based on cognitive change, pain neuroscience programs could be more effective than pain self-management programs, contributing to reconceptualize beliefs and minimize the level of threatening perceived by the brain. Gallagher et al (2013) reported effects of a pain neuroscience education program based on a book of metaphors compared to a pain self-management program (Back book) and reported greater immediate from pain neuroscience education on pain catastrophizing and pain knowledge. The hypothesis of this study is that a pain neuroscience education will show more effective results for pain intensity, catastrophizing and pain self-efficacy when compared to the pain self-management program in patients with CLBP. The purpose of this study will be to compare the immediate effects of an educational program focused on Pain Neuroscience Education vs. Pain self-management program for patients with chronic low back pain (CLBP) considering the outcomes of pain intensity, catastrophizing and pain self-efficacy. The investigators will recruit 108 with CLBP between 18 and 60 years and both genders. The sample size will be randomized into two arms: fifty participants will be submitted to Pain Neuroscience Education and the remaining fifty to Pain Self-Management education. Both interventions will be administered in one session (50 minutes). The programs will be showed as interactive workshops. Participants will be submitted to a brief initial assessment considering: pain intensity, fear of movement, anxiety and depression, catastrophizing, pain self-efficacy and global perceived effect.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 60 years;
- •Medical diagnosis of nonspecific CLBP in the last 3 months and/or pain at least half of the days in the past 6 months, that is located between T12 and the gluteal folds;
- •Pain intensity equal to or greater than three on numerical pain rating scale (NPRS)
- •Score greater than 14% on the Oswestry Disability Index and
- •Acceptable cognitive function assessed by Mini-Mental examination.
排除标准
- •red flags indicative of systemic involvement;
- •neurological symptoms, psychiatric, rheumatologic and cardiac diseases;
- •active radiculopathy;
- •lumbar stenosis;
- •spondylolisthesis;
- •history of spinal surgeries;
- •previous physical therapy for low back in the past year
结局指标
主要结局
Pain catastrophizing - Pain Catastrophizing Scale
时间窗: At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment
The PCS translated and validated to Brazilian Portuguese by Sehn et al. (2012) will be used. The scale is composed of 13 items staggered on 6-point ordinal scale (0-5). The total score is the sum of the items divided by the number of items answered, with the minimum score being 0 and the maximum being 5 for each item. Higher scores indicated a greater presence of catastrophizing thoughts. The total score of the scale could vary between 0 and 52 points. A recent systematic review found that catastrophizing to be associated with pain and disability at follow-up in CLBP patients (Wertli et al, 2014).
Pain Self-Efficacy
时间窗: At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment
Study participants will be evaluated on self-efficacy related to chronic pain, which can be defined as an individual's confidence he/she can successfully produce desirable results related to living with chronic pain. The PSES has 10 items which are rated on a 7-point ordinal scale (ranging from 0: "not at all confident" to 6: "completely confident"). The maximum score is 60 and higher the score, higher the level of self-confidence of the participant to self-manage their pain. It was adapted and validated to Brazilian Portuguese (Sarda et al, 2007). Previous research showed an effect on self-efficacy using a PNE intervention based on metaphors compared to an intervention using cognitive-behavioral concepts (Gallager et al, 2013).
Pain intensity - Numerical Pain Rating Scale (NPRS)
时间窗: At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment
The NPRS used to assess pain intensity in this trial will consist in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable" (Costa et al, 2008). Previous research has found the NPRS to be responsive to change, with a minimum clinically important difference (MCID) of 2.4 among patients with CLBP receiving exercise or education (Maughan and Lewis, 2010).
次要结局
- Exercise Adherence - Exercise Adherence Rating Scale(At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment)
- Global Perceived Effect(2 weeks after the initial assessment)
- Low Back Pain Disability - Oswestry Disability Index(At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment)
- Fear avoidance beliefs - The fear avoidance beliefs questionnaire (FABQ)(At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment)
- Anxiety and Depression - Hospital Anxiety and Depression Scale(At the beginning of the study (just after the randomization) and 2 weeks after the initial assessment)
研究者
Thais Cristina Chaves
Professor PhD
University of Sao Paulo