Department of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
Department of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
BMJ Open. 2020 Mar 8;10(3):e031592. doi: 10.1136/bmjopen-2019-031592.
A relevant subsample of patients with chronic low back pain (CLBP) have manifested augmented central pain processing, central sensitisation (CS). Patients with CLBP have limited functioning and participation. Theoretically, physical functioning in patients with CLBP can plausibly be linked to CS; however, evidence to explain such association is scarce. Moreover, there is no gold standard for CS diagnosis. The objectives of the study are: (1) to analyse the association between instruments assessing reference symptoms and signs attributed to CS; (2) to analyse whether reference symptoms and signs attributed to CS are associated with functioning measurement outcomes; and (3) to analyse whether changes (between baseline and discharge) in reference symptoms and signs attributed to CS are related to changes in each of the functioning measurement outcomes.
A cross-sectional and longitudinal observational study is performed with measurements taken at baseline and discharge of an interdisciplinary rehabilitation programme. A sample size of 110 adult patients with CLBP has been calculated for the study. CS measurements are: Central Sensitisation Inventory, quantitative sensory testing and heart rate variability. Functioning measurements are: lifting capacity, maximal aerobic capacity, accelerometry and reported functioning. Statistical analyses to be performed are: (1) correlation between CS measurements, (2) multiple regression between functioning (dependent variable) and CS measurements (independent variable), and (3) multiple regression between changes in scores of functioning (dependent variable) and CS measurements (independent variable), and corrected for sex and age.
The study obtained the clearance to its implementation from the Medical Research Ethics Committee of the University Medical Center Groningen in July 2017. The results will be disseminated through scientific publications in peer-reviewed journals, presentations at relevant conferences, and reports to stakeholders.
NTR7167/NL6980.
慢性下腰痛（CLBP）患者存在相关亚组，其表现为中枢性疼痛处理增强，即中枢敏化（CS）。CLBP 患者的功能和参与度有限。从理论上讲，CLBP 患者的身体功能可能与 CS 相关；但是，很少有证据可以解释这种关联。此外，CS 诊断尚无金标准。本研究的目的是：（1）分析评估 CS 相关参考症状和体征的工具之间的相关性；（2）分析 CS 相关参考症状和体征是否与功能测量结果相关；（3）分析 CS 相关参考症状和体征的变化（与基线相比和出院时）是否与每种功能测量结果的变化相关。
本研究采用了横断面和纵向观察性研究方法，在跨学科康复计划的基线和出院时进行了测量。为该研究计算了 110 名 CLBP 成年患者的样本量。CS 测量指标包括：中枢敏化量表、定量感觉测试和心率变异性。功能测量指标包括：举重能力、最大有氧能力、加速度计和报告的功能。将要进行的统计分析包括：（1）CS 测量指标之间的相关性；（2）功能（因变量）与 CS 测量指标（自变量）之间的多元回归；（3）功能评分变化（因变量）与 CS 测量指标（自变量）之间的多元回归，并针对性别和年龄进行了校正。
该研究于 2017 年 7 月获得了格罗宁根大学医学中心医学研究伦理委员会对其实施的许可。研究结果将通过同行评审期刊上的科学出版物、相关会议上的演讲以及向利益相关者的报告进行传播。
NTR7167/NL6980。
