Chiropractic, Real Centro Universitario Escorial Maria Cristina, San Lorenzo de El Escorial, Spain.
Department of Anatomy, Université du Québec à Trois-Rivières, Trois-Rivieres, Quebec, Canada.
BMJ Open. 2023 Feb 10;13(2):e065999. doi: 10.1136/bmjopen-2022-065999.
Chronic low back pain (CLBP) is a highly prevalent and disabling condition. Identifying subgroups of patients afflicted with CLBP is a current research priority, for which a classification system based on pain mechanisms was proposed. Spinal manipulative therapy (SMT) is recommended for the management of CLBP. Yet, little data are available regarding its mechanisms of action, making it difficult to match this intervention to the patients who may benefit the most. It was suggested that SMT may influence mechanisms associated with central sensitisation. Therefore, classifying patients with CLBP according to central sensitisation mechanisms may help predict their response to SMT.
This protocol describes a randomised placebo-controlled trial aiming to examine which variables linked to central sensitisation may help predict the clinical response to SMT in a cohort of patients with CLBP. One hundred patients with chronic primary low back pain will be randomised to receive 12 sessions of SMT or placebo SMT over a 4-week period. Pain intensity and disability will be assessed as primary outcomes after completing the 4-week treatment (primary endpoint), and at 4-week and 12-week follow-ups. Baseline values of two pain questionnaires, lumbar pressure pain thresholds, concentrations of an inflammatory cytokine and expectations of pain relief will be entered as predictors of the response to SMT in a multiple regression model. Changes in these variables after treatment will be used in a second multiple regression model. The reference values of these predictors will be measured from 50 age and sex-matched healthy controls to allow interpretation of values in patients. Mixed analyses of variance will also be conducted to compare the primary outcomes and the predictors between groups (SMT vs placebo) over time (baseline vs post-treatment).
Ethical approval was granted by the Fundación Jiménez Díaz Clinical Research Ethics Committee.
NCT05162924.
慢性下背痛（CLBP）是一种高发且致残的疾病。确定患有 CLBP 的患者亚组是当前的研究重点，为此提出了一种基于疼痛机制的分类系统。脊柱手法治疗（SMT）被推荐用于 CLBP 的治疗。然而，关于其作用机制的数据很少，因此难以将这种干预措施与最有可能受益的患者相匹配。有人认为 SMT 可能会影响与中枢敏化相关的机制。因此，根据中枢敏化机制对 CLBP 患者进行分类可能有助于预测他们对 SMT 的反应。
本方案描述了一项随机安慰剂对照试验，旨在研究与中枢敏化相关的哪些变量可能有助于预测 CLBP 患者对 SMT 的临床反应。将 100 名慢性原发性下背痛患者随机分为 SMT 组或安慰剂 SMT 组，在 4 周内接受 12 次治疗。完成 4 周治疗后（主要终点）以及 4 周和 12 周随访时，将疼痛强度和残疾作为主要结局进行评估。两个疼痛问卷、腰椎压痛阈值、炎症细胞因子浓度和疼痛缓解期望的基线值将作为 SMT 反应的预测因素输入到多元回归模型中。治疗后这些变量的变化将用于第二个多元回归模型。这些预测因子的参考值将从 50 名年龄和性别匹配的健康对照者中测量，以允许对患者的数值进行解释。还将进行混合方差分析，以比较组间（SMT 与安慰剂）在时间上（基线与治疗后）的主要结局和预测因子。
伦理批准由 Fundación Jiménez Díaz 临床研究伦理委员会授予。
NCT05162924。
