Abstract
OBJECTIVE: 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. DESIGN: This was an observational clinical study based on analyses of categorical data of patient-reported outcome measurements. SUBJECTS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.