Postoperative pain treatment after lumbar discectomy. A protocol for a systematic review with meta-analysis and trial sequential analysis.

BACKGROUND: Patients undergoing lumbar discectomy usually suffer from moderate to severe pain during the postoperative period. Multimodal, or balanced analgesia, is the leading treatment principle for managing postoperative pain. The rationale is to achieve optimal pain treatment through additive or synergistic effects of several non-opioid analgesics, and thereby, reducing the need for postoperative opioids, facilitating early mobilization and functional rehabilitation. For discectomy surgery, evidence of both the benefit and harm of different analgesic interventions is unclear. OBJECTIVES: This systematic review aims to investigate the benefits and harms of analgesic interventions in adult patients after lumbar discectomy. METHODS: This protocol for a systematic review is written according to The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search The Cochrane Library's CENTRAL, PubMed, EMBASE, and ClinicalTrails.gov for published and ongoing trials. All randomized clinical trials assessing the postoperative analgesics effect of an intervention with a control or no-intervention group undergoing lumbar discectomy will be included. Two authors will independently screen trials for inclusion using Covidence, extract data and assess the risk of bias using Cochrane's risk-of-bias 2 tool. We will analyse the data using Review Manager and Trial Sequential Analysis. Meta-analysis will be performed according to the Cochrane guidelines. We will present our primary findings in a 'summary of findings' table and evaluate the overall certainty of evidence using the GRADE approach. DISCUSSION: This systematic review will assess the benefits and harms of analgesic interventions after lumbar discectomy and have the potential to improve best practices and advance research.

The efficacy and safety of oral antibiotic treatment in patients with chronic low back pain and Modic changes: A systematic review and meta-analysis.

Background: This systematic review and meta-analysis aimed to summarize evidence regarding the effectiveness and safety of oral antibiotic intervention for chronic low back pain (CLBP) patients with/without type-1 Modic changes (MC1). Methods: AMED, CINAHL, Cochrane Library, Embase, and Medline were searched from inception to March 3, 2023. Randomized controlled trials (RCTs) or non-RCTs that investigated the effectiveness or safety of oral antibiotics in treating CLBP patients were eligible for inclusion. Two independent reviewers screened abstracts, full-text articles, and extracted data. The methodological quality of each included article were evaluated by RoB2 and NIH quality assessment tools. The quality of evidence was appraised by GRADE. Meta-analyses were performed, where applicable. A subgroup analysis was conducted to evaluate the RCTs and case series separately, and to evaluate the effect of removing a low-quality RCT. Results: Three RCTs and four case series were included. All Amoxicillin-clavulanate/Amoxicillin treatments lasted for approximately 3 months. Moderate- and low-quality evidence suggested that antibiotic was significantly better than placebo in improving disability and quality of life in CLBP patients with MC1 at 12-month follow-up, respectively. Low-quality evidence from meta-analyses of RCTs showed that oral antibiotic was significantly better than placebo in improving pain and disability in CLBP patients with MC1 immediately post-treatment. Very low-quality evidence from the case series suggested that oral Amoxicillin-clavulanate significantly improved LBP/leg pain, and LBP-related disability. Conversely, low-quality evidence found that oral Amoxicillin alone was not significantly better than placebo in improving global perceived health in patients with CLBP at the 12-month follow-up. Additionally, oral antibiotic users had significantly more adverse effects than placebo users. Conclusions: Although oral antibiotics were statistically superior to placebo in reducing LBP-related disability in patients with CLBP and concomitant MC1, its clinical significance remains uncertain. Future large-scale high-quality RCTs are warranted to validate the effectiveness of antibiotics in individuals with CLBP.

Stand-alone ALIF versus TLIF in patients with low back pain - A propensity-matched cohort study with two-year follow-up.

Introduction: Instrumented lumbar fusion by either the anterior or transforaminal approach has different advantages and disadvantages. Few studies have compared PatientReported Outcomes Measures (PROMs) between stand-alone anterior lumbar interbody fusion (SA-ALIF) and transforaminal lumbar interbody fusion (TLIF). Research question: This is a register-based dual-center study on patients with severe disc degeneration (DD) and low back pain (LBP) undergoing single-level SA-ALIF or TLIF. Comparing PROMs, including disability, quality of life, back- and leg-pain and patient satisfaction two years after SA-ALIF or TLIF, respectively. Material and methods: Data were collected preoperatively and at one and two-year follow-up. The primary outcome was Oswestry Disability Index (ODI). The secondary outcomes were patient satisfaction, walking ability, visual analog scale (VAS) scores for back and leg pain, and quality of life (QoL) measured by the European Quality of Life-5 Dimensions (EQ-5D) index score. To reduce baseline differences between groups, propensity-score matching was employed in a 1:1 fashion. Results: 92 patients were matched, 46 S A-ALIF and 46 TLIF. They were comparable preoperatively, with no significant difference in demographic data or PROMs (P > 0.10). Both groups obtained statistically significant improvement in the ODI, QoL and VAS-score (P < 0.01), but no significant difference was observed (P = 0.14). No statistically significant differences in EQ-5D index scores (P = 0.25), VAS score for leg pain (P = 0.88) and back pain (P = 0.37) at two years follow-up. Conclusion: Significant improvements in ODI, VAS-scores for back and leg pain, and EQ-5D index score were registered after two-year follow-up with both SA-ALIF and TLIF. No significant differences in improvement.

A definition and clinical grading of Modic changes.

To provide an up-to-date description of knowledge and pitfalls related to the classification, definition and grading of Modic changes (MC) visualized on magnetic resonance imaging (MRI). State-of-the-art review of current knowledge regarding the definition and grading of MC on MRI. MC on MRI have been reported to be associated with low back pain and disability. However, previous studies have shown heterogeneous results in regards to the impact of MC and its clinical relevance in patients with back pain. MC is a term used with considerable variation in the literature. No strict definition has been provided previously, this has contributed to varying diagnostic inclusion criteria, heterogeneous study populations, and discrepancy in results. A definition of MC and a proposal for grading is provided in this state-of-the-art review. MC are important, clinically relevant findings. However, issues with the nomenclature, definition and grading of these changes need to be addressed. Our current review highlights relevant issues related to MC, and provides a definition and grading score for the term MC that includes the Modic type and the extent of vertebral body involvement. Future studies should seek to validate the MC grading score in clinically relevant populations.

The Clinical Significance of the Modic Changes Grading Score.

STUDY DESIGN: Cross-sectional retrospective observational study. OBJECTIVE: To evaluate the reliability and clinical utility of the Modic changes (MC) grading score. METHOD: Patients from the Danish national spine registry, DaneSpine, scheduled for lumbar discectomy were identified. MRI of patients with MC were graded based on vertical height involvement: Grade A (<25%), Grade B (25%-50%), and Grade C (>50%). All MRIs were reviewed by 2 physicians to evaluate the reliability of the MC grade. RESULTS: Of 213 patients included, 142 patients had MC, 71 with MC-1 and 71 with MC-2; 34% were Grade A, 45% were Grade B, and 21% were Grade C. MC grade demonstrated substantial intra-rater (κ = .68) and inter-rater (κ = .61) reliability. A significantly higher proportion (n = 40, 57%) of patients with MC-1 had a severe MC grade compared to patients with MC-2 (n = 30, 43%, P < .001). Severe MC grade was associated with the presence of severe lumbar disc degeneration (DD) (Pfirrmann grade = V, P = .024), worse preoperative ODI (52.49 vs 44.17, P = .021) and EQ-5D scores (.26 vs .46, P = .053). MC alone including type was not associated with a significant difference in patient-reported outcomes (P > .05). CONCLUSION: The MC grade score was demonstrated to have substantial intra- and inter-observer reliability. Severe MC grade was associated with both severe DD and MC type, being more prevalent in patients with MC-1. The MC grade was also significantly associated with worse disability and reduced health-related quality of life. Results from the study suggest that MC grade is more clinically important than MC type.

Clinical outcome of stand-alone ALIF compared to posterior instrumentation for degenerative disc disease: A pilot study and a literature review.

The objective of the article was to: a) present results from a case cohort pilot study comparing stand-alone ALIF and TLIF and, b) review the literature on studies comparing the clinical outcome of stand-alone ALIF with posterior instrumentation including TLIF or PLIF, in patients with disabling low back pain resulting from degenerative disc disease. ALIF surgery has previously been linked with certain high risk complications and unfavorable long term fusion results. Newer studies suggest that stand-alone ALIF can possibly be advantageous compared to other types of posterior instrumented interbody fusion for a selected group of DDD patients. The methods and material consisted of a cohort pilot study of patients, with DDD treated with stand-alone ALIF or TLIF followed by a literature review conducted through a comprehensive PubMed database search of the English literature. Studies comparing stand-alone ALIF with posterior instrumented interbody fusion were selected and reviewed. Results from the pilot study, n = 21, showed a reduced perioperative blood loss, shorter operative time and a trend towards better pain reduction and decreased use of opioid analgesics in patients undergoing stand-alone ALIF compared to posterior instrumented fusion with TLIF. The literature review included three studies, n = 630. All three studies were retrospective cohort studies. The average patient follow-up was 2-years but with heterogeneous selected outcomes. Two of three articles documented significant advantages when using stand-alone ALIF on outcomes such as ODI, VAS, surgical time, blood loss and patient satisfaction. No study found stand-alone ALIF inferior in chosen outcomes including fusion. In conclusion the pilot study and the literature review, finds similar clinical outcomes and fusion rates after stand-alone ALIF and posterior interbody fusion. Stand-alone ALIF was associated with a shorter duration of surgery, less perioperative blood loss and a faster improvement post-operatively. Therefore stand-alone ALIF is a viable and important surgical option, which could be considered first choice as surgical treatment.