Cognitive Behavioural Treatment With Support on Communication and Information Technologies for the Management of Chronic Low Back Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in Disability: Change in the Roland-Morris Questionnaire
研究概览
简要总结
The objective of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural Treatment program for chronic low back pain supported by information and communication technologies
详细描述
Background: Psychological treatments have been successful in the treatment of chronic low back pain (CLBP). However the effect sizes are still modest and there is room for improvement. A way to progress in this line is enhancing treatment adherence and self-management by means of information and communication technologies (ICT). The objective of this study is to investigate the short- and long-term efficacy of a Cognitive Behavioural Treatment (CBT) group program for CLBP supported versus non-supported by ICTs. A secondary objective is to evaluate the influence of relevant variables in treatment response. Possible barriers in the implementation of CBT with and without ICT will be also investigated.
Methods: A randomized controlled trail with 180 CLBP patients recruited in specialized care will be conducted. Participants will be randomly assigned to three conditions: Control group (CG), Cognitive Behavioural program (CBT), and CBT supported by ICTs (CBT + ICT). Participants belonging to the three conditions will receive a conventional rehabilitation program (back school). The CBT group program will last six sessions. The CBT + ICT will use the Internet and SMS in order to practice the therapeutic strategies between sessions and in the follow-ups in their homes. Primary outcome variables are self-reported disability and pain intensity. Assessment will be carried out by blinded assessors in five moments: pre-treatment, post-treatment and 3-, 6-, and 12-month follow-up. The influence of catastrophizing, fear-avoidance beliefs, anxiety and depression in response to treatment in the primary outcomes will be also analysed.
Discussion This study will show data of the possible benefits of the use of ICTs in the improvement of CBT for the treatment of CLBP
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 20 and 65 years
- •suffering low back pain for at least 6 months
- •availability of mobile phone in order to get SMS
- •access to computer with Internet connection in order to be able to use the CBT program supported by ICT
排除标准
- •mental retardation
- •not proficient in Spanish
- •neurogenic claudication or neurologic deficit
- •history of vertebral fracture, previous lumbar surgery
- •vertebral infection
- •spinal or nerve tumor
- •severe mental disorder or substance abuse or dependence.
结局指标
主要结局
Change in Disability: Change in the Roland-Morris Questionnaire
时间窗: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
The Roland-Morris Questionnaire is one of the most widely used measures to assess disability in patients with low back pain, and it has shown good psychometrics properties (reliability and validity). The Spanish version of the RM will be completed by the patients. This questionnaire was designed to evaluate low back pain, with 24 statements that describe different daily activities that can be affected by low back pain. The participant has to select those statements that describe the limitations produced by low back pain.
Change in Pain measured by Numerical Rating Scale (NRS)
时间窗: five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).
Pain: IMMPACT recommends the use of Numerical Rating Scales (NRS) as a core outcome measure of efficacy in clinical trials of chronic pain treatments. The scale is composed of 11 numbers ranging from 0 to 10 with 0 meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'. Two different scales will be used, one to assess low back pain and the other one to assess sciatica pain
次要结局
- Change in Pain coping strategies(five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).)
- Change in Anxiety and Depression(five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).)
- Change in Fear-Avoidance Beliefs(five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).)
- Change in Catastrophizing(five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).)
- Change in Quality of life assessed by the SF-12 questionnaire(five assessment periods (pre-treatment, post-treatment, and three follow-ups at 3, 6 and 12 months).)