School of Rehabilitation Science, McMaster University, 1400 Main St. W, Hamilton, ON L8S 1C7, Ontario, Canada.
School of Physical Therapy, Western University, London, Ontario, Canada.
Trials. 2015 Oct 14;16:462. doi: 10.1186/s13063-015-0994-5.
Previous research suggests that self-management programs for people with chronic pain improve knowledge and self-efficacy but result in negligible effects on function. This study will investigate the effectiveness self-management support with pain science education and exercise on improving function for people with chronic pain in comparison to a wait-list control. A secondary objective is to determine which variables help to predict response to the intervention.
METHODS/DESIGN: This study will be an unblinded, randomized controlled trial with 110 participants comparing a 6-week program that includes self-management support, pain science education and exercise to a wait-list control. The primary outcome will be function measured by the Short Musculoskeletal Function Assessment - Dysfunction Index. Secondary outcomes will include pain intensity measured by a numeric pain rating scale, pain interference measured by the eight-item PROMIS pain interference item-bank, how much patients are bothered by functional problems measured by the Short Musculoskeletal Function Assessment - Bother Index, catastrophic thinking measured by the Pain Catastrophizing Scale, fear of movement/re-injury measured by the 11-item Tampa Scale of Kinesiophobia, sense of perceived injustice measured by the Injustice Experience Questionnaire, self-efficacy measured by the Pain Self-Efficacy Questionnaire, pain sensitivity measured by pressure pain threshold and cold sensitivity testing, fatigue measured by a numeric fatigue rating scale, pain neurophysiology knowledge measured by the Neurophysiology of Pain Questionnaire, healthcare utilization measured by number of visits to a healthcare provider, and work status. Assessments will be completed at baseline, 7 and 18 weeks. After the 18-week assessment, the groups will crossover; however, we anticipate carry-over effects with the treatment. Therefore, data from after the crossover will be used to estimate within-group changes and to determine predictors of response that are not for direct between-group comparisons. Mixed effects modelling will be used to determine between-group differences for all primary and secondary outcomes. A series of multiple regression models will be used to determine predictors of treatment response.
This study has the potential to inform future self-management programming through evaluation of a self-management program that aims to improve function as the primary outcome.
ClinicalTrials.gov NCT02422459 , registered on 13 April 2015.
先前的研究表明，针对慢性疼痛患者的自我管理计划可以提高知识和自我效能感，但对功能的改善效果可忽略不计。本研究将调查自我管理支持与疼痛科学教育和运动相结合，对慢性疼痛患者的功能改善效果与等待名单对照相比的有效性。次要目标是确定哪些变量有助于预测对干预的反应。
方法/设计：这是一项非盲、随机对照试验，共纳入 110 名参与者，比较了为期 6 周的方案，该方案包括自我管理支持、疼痛科学教育和运动，与等待名单对照。主要结局指标是由短肌肉骨骼功能评估 - 功能障碍指数测量的功能。次要结局指标包括用数字疼痛评分量表测量的疼痛强度、用 8 项 PROMIS 疼痛干扰项目库测量的疼痛干扰、用短肌肉骨骼功能评估 - 困扰指数测量的患者对功能问题的困扰程度、用疼痛灾难化量表测量的灾难性思维、用 11 项 Tampa 运动恐惧症量表测量的运动恐惧/再损伤、用不公平体验问卷测量的感知不公平感、用疼痛自我效能问卷测量的自我效能感、用压力疼痛阈值和冷敏感测试测量的疼痛敏感性、用数字疲劳评分量表测量的疲劳、用疼痛神经生理学问卷测量的疼痛神经生理学知识、用就诊次数测量的医疗保健利用情况，以及工作状态。评估将在基线、7 周和 18 周时进行。在 18 周评估后，两组将交叉；然而，我们预计会有治疗的延续效应。因此，将使用交叉后的数据来估计组内变化，并确定不是直接进行组间比较的反应预测因子。混合效应模型将用于确定所有主要和次要结局的组间差异。一系列多元回归模型将用于确定治疗反应的预测因子。
本研究通过评估以功能改善为主要结局的自我管理计划，为未来的自我管理计划提供了信息。
ClinicalTrials.gov NCT02422459，于 2015 年 4 月 13 日注册。
