Mylenbusch Heidi, Schepers Michiel, Kleinjan Elmar, Pol Marije, Tempelman Henk, Klopper-Kes Hanneke
Stichting Rugpoli Twente, Veluwe, Brabant, Randstad - Multidisciplinary Center for Spine and Musculoskeletal Disorders, the Netherlands.
Interv Pain Med. 2023 Nov 15;2(4):100292. doi: 10.1016/j.inpm.2023.100292. eCollection 2023 Dec.
This study investigated whether patients with Modic changes (MC) of types I, I/II, and II would respond to an anti-inflammatory-based, stepped care treatment with three treatment steps: first, oral administration of NSAIDs, 2 × 200 mg celecoxib daily for two weeks; second, an intradiscal steroid injection (ID) with dexamethasone and cefazolin; and third, oral treatment with antibiotics (AB), 3 × 1 g amoxicillin daily for 100 days.
This was an observational clinical study based on analyses of categorical data of patient-reported outcome measurements.
Subjects were consecutive patients with chronic low back pain (CLBP), diagnosed by assessment of anamnestic signs of inflammation; a pain score ≥6 on the Numeric Pain Rating Scale (NPRS); a mechanical assessment; MC I, I/II, or II based on MRI; and lack of response to conservative treatment.
From January 1, 2015, to December 31, 2021, 833 eligible patients were selected for the stepped care treatment. A total of 332 patients completed requested follow-up questionnaires at baseline and 12 months (optional at 3 and 6 months). Primary outcomes were pain (at least 50 % pain relief) and/or a minimum of 40 % improvement in functionality as measured by the Roland Morris Disability Questionnaire (RMDQ) or the Oswestry Disability Questionnaire (ODI). Secondary outcome measures were use of pain medication and return to work.
At 1 year of follow-up, 179 (53.6 %) of 332 patients reported improvement according to the responder criteria. Of the 138 patients that had received only NSAIDs, 88 (63.8 %) had improved. In addition, 50 (56.8 %) of the 183 patients that had received ID had improved, and 41 (38.7 %) of the 106 patients treated with AB had improved. None of the patients reported complications. 12.0 % of patients using AB stopped preterm due to undesirable side effects.
Treatment with a stepped care model for inflammatory pain produced clinically relevant, positive reported outcomes on pain and/or function. Our stepped care model appears to be a useful, safe, and cost-saving treatment option that is easily reproducible. Further studies, including randomized controlled trials and analyses of subgroups, may help to develop a more patient-tailored approach and further avoidance of less-effective treatments and costs.
本研究调查了I型、I/II型和II型Modic改变（MC）患者是否会对基于抗炎的阶梯式护理治疗产生反应，该治疗包括三个治疗步骤：首先，口服非甾体抗炎药，每日2次，每次200 mg塞来昔布，持续两周；其次，进行椎间盘内类固醇注射（ID），使用地塞米松和头孢唑林；第三，口服抗生素（AB），每日3次，每次1 g阿莫西林，持续100天。
这是一项基于患者报告结局测量的分类数据分析的观察性临床研究。
研究对象为连续性慢性下腰痛（CLBP）患者，通过评估炎症的既往症状进行诊断；数字疼痛评分量表（NPRS）上的疼痛评分≥6；进行了力学评估；基于MRI诊断为MC I型、I/II型或II型；对保守治疗无反应。
从2015年1月1日至2021年12月31日，选择833例符合条件的患者进行阶梯式护理治疗。共有332例患者在基线和12个月时（3个月和6个月为可选）完成了要求的随访问卷。主要结局为疼痛（至少50%的疼痛缓解）和/或通过罗兰·莫里斯残疾问卷（RMDQ）或奥斯威斯利残疾问卷（ODI）测量的功能至少改善40%。次要结局指标为止痛药物的使用和重返工作岗位情况。
在随访1年时，332例患者中有179例（53.6%）根据反应标准报告有改善。在仅接受非甾体抗炎药治疗的138例患者中，88例（63.8%）有改善。此外，在接受ID治疗的183例患者中，50例（56.8%）有改善，在接受AB治疗的106例患者中，41例（38.7%）有改善。没有患者报告并发症。12.0%使用AB的患者因不良副作用提前停药。
采用阶梯式护理模式治疗炎性疼痛在疼痛和/或功能方面产生了具有临床意义的积极报告结局。我们的阶梯式护理模式似乎是一种有用、安全且节省成本的治疗选择，易于重复实施。进一步的研究，包括随机对照试验和亚组分析，可能有助于制定更适合患者的方法，并进一步避免效果不佳的治疗和成本。
