Department of Neurosurgery, Leiden University Medical Center, Albinusdreef 2, PO Box 9600, 2300 RC, Leiden, the Netherlands.
Department of Neurosurgery, Spaarne Hospital, Haarlem, the Netherlands.
BMC Neurol. 2024 Aug 20;24(1):290. doi: 10.1186/s12883-024-03801-1.
Transforaminal epidural injections (TEI) can alleviate symptoms and help to maintain physical functioning and quality of life in patients with lumbar radicular pain. We aim to develop a prediction model for patient outcome after TEI in patients suffering from unilateral lumbar radicular pain due to lumbar disc herniation (LDH) or single-level spinal stenosis (LSS). The secondary aim is to estimate short-term patient outcome differences between LDH and LSS patients, the association between psychological variables and patient outcome, the rate of additional injections, surgery and complications, and to explore the short-term cost-effectiveness of TEI.
This study is designed as a multi-centre, observational, prospective cohort study in two large regional hospitals in the Netherlands. Patients diagnosed with unilateral lumbar radicular pain secondary to LDH or LSS and congruent with MRI findings, who are referred for TEI along usual care pathways, are eligible for study participation. A total of 388 patients with LDH or LSS will be included. A pre-defined set of demographic, clinical and radiological variables will be used as the predictors in the model. The primary outcome measure is the Numerical Rating Scale (NRS) for leg pain. Secondary outcome measures include back pain, physical functioning, perceived recovery, pain coping strategies, anxiety and depression and use of analgesics and physical therapy. Patients will be evaluated at baseline, 2 weeks and 6 weeks after treatment. NRS leg pain and Likert perceived recovery data will be used as the dependent variables in a generalized linear mixed model for prediction of TEI outcome, with internal validation of performance (explained variation) by bootstrap resampling. Cost-effectiveness for a period of 6 weeks prior to and after treatment will be performed with decision-analytic modelling.
Patients with severe lumbar radicular pain often request additional treatment when conservative care is insufficient. TEI can offer relief of symptoms. Currently, it is not possible to predict responsiveness to this treatment for individual patients. This study is designed to explore predictors that can differentiate between patients that will and will not have a positive outcome after TEI. This information may support treatment strategies for this patient group.
This study is registered at ClinicalTrials.gov database under registry number NCT04540068 on September 1, 2020.
经椎间孔硬膜外注射（TEI）可以缓解症状，并有助于维持腰椎神经根痛患者的身体功能和生活质量。我们旨在为单侧腰椎神经根痛患者（由于腰椎间盘突出症（LDH）或单节段椎管狭窄症（LSS））的 TEI 后患者的预后建立预测模型。次要目的是估计 LDH 和 LSS 患者之间的短期患者预后差异，心理变量与患者预后之间的关系，额外注射、手术和并发症的发生率，并探讨 TEI 的短期成本效益。
本研究是在荷兰两家大型区域医院进行的多中心、观察性、前瞻性队列研究。符合 MRI 发现并经常规护理途径转介进行 TEI 的单侧腰椎神经根痛患者，符合单侧腰椎神经根痛患者的诊断标准，且符合 LDH 或 LSS 诊断标准，有资格参加本研究。共有 388 例 LDH 或 LSS 患者将被纳入研究。一套预先确定的人口统计学、临床和影像学变量将作为模型中的预测因子。主要结局测量指标是腿部疼痛的数字评定量表（NRS）。次要结局包括腰痛、身体功能、感知恢复、疼痛应对策略、焦虑和抑郁以及镇痛药和物理治疗的使用。患者将在治疗前、治疗后 2 周和 6 周进行评估。NRS 腿部疼痛和感知恢复 Likert 数据将作为 TEI 结果的广义线性混合模型中的因变量，通过 bootstrap 重采样进行性能（解释变化）的内部验证。在治疗前和治疗后 6 周内进行决策分析模型的成本效益分析。
严重腰椎神经根痛的患者在保守治疗不足时经常要求额外的治疗。TEI 可以缓解症状。目前，无法预测个体患者对这种治疗的反应性。本研究旨在探讨可以区分 TEI 后阳性和阴性结局患者的预测因子。这些信息可能有助于为这一患者群体制定治疗策略。
该研究于 2020 年 9 月 1 日在 ClinicalTrials.gov 数据库中注册，注册号为 NCT04540068。
