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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 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 analyze 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.

Study Design.This was a dual-center study over an eight-year period on patients undergoing single level fusion surgery with either posterior- (PLIF) or transforaminal lumbar interbody fusion (TLIF). We analyzed prospectively collected pre- and postoperative data from the national Danish surgical spine database (DaneSpine).Objective.The aim of this study was to compare clinical and patient-reported outcome (PRO) 2 years after TLIF or PLIF in patients with symptomatic lumbar mechanical disc degeneration.Summary of Background Data.PLIF and TLIF are well-described techniques for treating lumbar mechanical disc degeneration but whether the theoretical differences between the two techniques translate to different clinical outcomes is unknown.Methods.The primary outcome was Oswestry Disability Index (ODI) score at 2-year follow-up. Secondary outcome measures were scores on the European Quality of Life-5 Dimensions (EQ-5D) and visual analog scale (VAS) and the rate of intraoperative complications. To minimize baseline differences between the groups, propensity-score matching was employed in a 1:1 fashion, balancing the groups on preoperative factors including age, sex, back and leg pain, ODI, EQ-5D, and previous spine surgery.Result.The matched cohort included 211 patients in each cohort. There was no significant difference between the groups in the mean score on the ODI at two years (PLIF: 33 ± 20 vs. TLIF: 35 ± 20, P = 0.328). We found no statistically significant differences in EQ-5D score (0.54 ± 0.35 vs. 0.51 ± 0.34, P = 0.327), VAS score for back pain (47 ± 32 vs. 48 ± 29, P = 0.570) or leg pain (42 ± 33 vs. 41 ± 32, P = 0.936) between the PLIF and TLIF groups, respectively, at 2-year follow-up. Dural tears occurred in 9.5% in the PLIF group and 1.9% in the TLIF group (P = 0.002) corresponding to a relative risk of 5.0 (95% CI 1.7-14.4).Conclusion.We found no significant difference in PRO at 2-year follow-up between PLIF and TLIF for the treatment of lumbar disc degeneration. PLIF is associated with a five times higher risk of dural tears.Level of Evidence: 3.

STUDY DESIGN: A registry-based comparative cohort study with 2-year follow-up.OBJECTIVE: To assess whether Modic changes (MCs) are associated with health-related quality of life, long-term physical disability, back- or leg pain after discectomy.SUMMARY OF BACKGROUND DATA: Previous studies have failed to show a clinically significant association between MCs and patient-reported outcomes (PROs) after discectomy.METHODS: Data from the Danish National Spine Registry on patients undergoing first-time lumbar discectomy at a single institution from 2014 to 2017 with an accessible preoperative lumbar magnetic resonance imaging, complete preoperative, and 2-year follow-up questionnaires were obtained. PROs including Oswestry disability index (ODI), European Quality of Life-Five Dimensions (EQ-5D), visual analogue scale (VAS) back and leg pain, and patient satisfaction were collected. Patients were stratified based on the presence (+MC) or absence (-MC) of MCs on the preoperative MRI.RESULTS: Of 620 patients included, MCs were present in 290 patients (47%). Of these, MC type 1 (MC-1) was present in 73 (25%) and MC type 2 (MC-2) in 217 (75%) patients. Preoperative data for ODI, EQ-5D, VAS-BP, and VAS-LP were comparable for the +MC and -MC groups. Both groups had a statistically significant improvement in PROs from baseline compared with 2-year follow-up (P CONCLUSION: MCs were not found to be associated with health-related quality of life, disability, back- or leg pain, or patient satisfaction 2 years after discectomy.LEVEL OF EVIDENCE: 2.

Study Design: Longitudinal cohort study with 13-year follow-up. Objective: To assess whether long-term disability is associated with baseline degenerative magnetic resonance imaging (MRI) findings in patients with low back pain (LBP). Methods: In 2004-2005, patients aged 18 to 60 years with chronic LBP were enrolled in a randomized controlled trial and lumbar MRI was performed. Patients completed the Roland-Morris Disability Questionnaire (RMDQ) and the LBP Rating Scale, at baseline and 13 years after the MRI. Multivariate regression analysis was performed with 13-year RMDQ as the dependent variable and baseline disc degeneration (DD, Pfirrmann grade), Modic changes (MC), facet joint degeneration (FJD, Fujiwara grade) smoking status, body mass index, and self-reported weekly physical activity at leisure as independent variables. Results: Of 204 patients with baseline MRI, 170 (83%) were available for follow-up. Of these, 88 had Pfirrmann grade >III (52%), 67 had MC (39%) and 139 had Fujiwara grade >2 (82%) on at least 1 lumbar level. Only MC (β = −0.15, P = .031) and weekly physical activity at leisure (β = −0.51, P < .001) were significantly, negatively, associated with 13-year RMDQ-score ( R2 = 0.31). Conclusion: DD and FJD were not associated with long-term disability. Baseline MC and weekly physical activity at leisure were statistically significantly associated with less long-term disability.

Infection has been proposed as a cause of back pain in individuals with Modic changes. This review summarises the knowledge on this topic in Scandinavia. A Norwegian randomized controlled trial could not replicate results in favor of antibiotic treatment for such patients. A Danish study demonstrated that patients with low back pain and Modic changes had similar physical disability-scores and less sick leave due to back pain than individuals without Modic changes at long-term follow-up (10 years). A Swedish study displayed equal bacterial presence in discs of patients operated for lumbar disc herniation and in control patients, indicating that the presence of bacteria is caused by contamination during the surgical procedure and is not related to back pain.

This report is based on results from three research groups in Sweden (Fritzell et al), Denmark (Udby et al), and Norway (Bråten et al). The groups have conducted studies published in international journals in 2019 [8-10]. The results complement each other and strongly suggest that antibiotics, in the absence of clear signs of a clinically relevant infection (discitis/spondylitis), should not be used for back pain with or without leg pain. The Swedish study showed that bacteria found in the disc/vertebra during surgery are very likely due to contamination [8], the Danish study showed that patients with Modic Changes (MC) on MR in the long term were not associated with more back pain or functional impairment than in patients without MC [9], and the Norwegian study showed that antibiotics for residual back pain after previous disc herniation had no better clinical effect than placebo [10]. Antibiotic resistance is one of the biggest threats to public health today and in the future.

Antibiotics have been suggested as treatment for selected patients with chronic back pain, with or without leg pain, and in association with Modic changes type 1 (MC1) on MRI (Modic et al. 1988, Albert et al. 2013a). The hypothesis is that various bacteria, but above all the common skin bacterium Cutibacterium acnes (formerly Propionibacterium acnes), would spread hematogenously to degenerated discs, where a “low-grade subclinical infection” would trigger an inflammatory reaction and cause MC1 (Albert et al. 2013a), irritate nociceptive nerve endings, and induce pain. Other studies have not found this connection, or have been cautious in their conclusions (Birkenmaier 2013, Urquhart et al. 2015) but have not had the same public impact. Since back/leg pain is common, and Modic changes occur in people with or without back/leg pain (Wang et al. 2012), and as antibiotic resistance is a major health threat (Carlsson et al. 2019), the suggestion of treating chronic back/leg pain with antibiotics must be thoroughly investigated. Research groups in Sweden, Denmark, and Norway have independently conducted studies from 3 different perspectives, but with a focus on the same basic questions: is there a causative link between Modic changes, back pain, and bacteria. The studies, all published during 2019, conclude that antibiotics should not be used for back/leg pain, unless there is a clinically relevant infection in the disc/vertebra (discitis/spondylitis).

BACKGROUND CONTEXT Lumbar spinal stenosis (LSS) is a common condition in the elderly population and is associated with significant morbidity and decreased quality of life. Many patients manage with little to no treatment, but for the patients in whom lower extremity pain and disability are unacceptable, surgical intervention is shown to provide good relief of symptoms and pain. There is little evidence on how many patients obtain a clinically relevant improvement in function and whether this effect is sustained 5 years after surgery. PURPOSE The aim of this study was to evaluate the proportion of patients who achieve and maintain a clinically relevant improvement at 1, 2 and 5 years postoperatively. STUDY DESIGN/SETTING The study was performed as a retrospective cohort study on patients who underwent surgery at the Spine Centre of Southern Denmark, Middelfart; The Regional Hospital of Silkeborg and University Hospital of Zealand in Koge. PATIENT SAMPLE A total of 6,063 patients who underwent decompression due to spinal stenosis at three spine centers in Denmark were included in our study. We had follow-up data available on our main outcome measure (ODI) on 75% at 1-year, 70% at 2-year, and 62% at 5-year follow-up. OUTCOME MEASURES Oswestry Disability Index (ODI), EuroQoL-5D-3L (EQ-5D), visual analogue scale leg pain (VAS-leg) and visual analogue scale back pain (VAS-back). METHODS We included patients who underwent first-time decompression due to LSS at three tertiary Spine Centers in Denmark. Data was collected prospectively in the National Spine Registry of Denmark (DaneSpine). Based on the outcome measures, the patients who obtained a minimal clinically relevant difference in outcome (MCID) were identified at 1-, 2- and 5-years post-surgery. RESULTS The mean change from baseline to 5-years post-surgery was 0.2 on EQ-5D; -18.9 on ODI, -18.9 on VAS back and 29.8 on VAS. We found that 86% of patients obtained the MCID on at least one parameter, with 68.9% obtaining MCID on two or more outcome measures. VAS back was found with a statistically important difference in the percentage of patients who achieved MCID at 1- and 5-years postsurgery. For the remaining outcome measures no statistically important difference was found. CONCLUSIONS Decompression as treatment for LSS is a safe and reliable option with low complication rates. Most patients achieve a clinically relevant difference in outcome on one or more parameters, which is maintained 5 years after surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

BACKGROUND CONTEXT Previous studies have failed to show a clinically significant association between Modic changes (MCs) and patient-reported outcomes (PROs) after discectomy. PURPOSE To assess whether Modic changes (MCs) are associated with health-related quality of life, long-term physical disability, back or leg pain after discectomy. STUDY DESIGN/SETTING A registry-based comparative cohort study with two-year follow-up. PATIENT SAMPLE n=620. OUTCOME MEASURES PROs including ODI, EQ-5D, VAS back and leg pain and patient satisfaction were collected. METHODS Data from the Danish National Spine Registry on patients undergoing first-time lumbar discectomy at a single institution from 2014-17 with an accessible preoperative lumbar MRI, complete preoperative and two-year follow-up questionnaires were obtained. Patients were stratified based on the presence (+MC) or absence (-MC) of MCs on the preoperative MRI. RESULTS Of 620 patients included, MCs were present in 270 patients (47%). Of these, MC type 1 (MC-1) was present in 70 (25%) and MC type 2 (MC-2) in 210 (75%) patients. Preoperative data for ODI, EQ-5D, VAS-BP, and VAS-LP were comparable for the +MC and -MC groups. Both groups had a statistically significant improvement in PRO's from baseline compared to two-year follow-up (p CONCLUSIONS MCs were not found to be associated with health-related quality of life, disability, back- or leg pain or patient satisfaction two years after discectomy. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

STUDY DESIGN: A comparative cohort study with 13-year follow-up.OBJECTIVE: To assess whether Modic changes (MCs) are associated with long-term physical disability, back pain, and sick leave.SUMMARY OF BACKGROUND DATA: Previous studies have shown a conflicting association of low back pain (LBP) with MCs and disc degeneration. The long-term prognosis of patients with MCs is unclear.METHODS: In 2004 to 2005, patients aged 18 to 60 with daily LBP were enrolled in an randomized controlled trial study and lumbar magnetic resonance imaging (MRI) was performed. Patients completed numeric rating scales (0-10) for LBP and leg pain, Roland-Morris Disability Questionnaire (RMDQ), LBP Rating Scale for activity limitations (RS, 0-30), inflammatory pain pattern and sick leave days due to LBP at baseline and 13 years after the MRI. Patients were stratified based on the presence (+MC) or absence (-MC) of MCs on the MRI.RESULTS: Of 204 cases with baseline MRI, 170 (83%) were available for follow-up; 67 (39%) with MCs and 103 (61%) without MCs. Demographics, smoking status, BMI, use of antibiotics, LBP, leg pain, and inflammatory pain pattern scores at baseline and at 13-year follow-up were similar between the two groups. Also, baseline RMDQ was similar between the +MC and -MC groups. At 13 years, the RMDQ score was statistically significant better in the +MC group (7.4) compared with the -MC group (9.6, P = 0.024). Sick leave days due to LBP were similar at baseline but less in the +MC group (9.0) compared with the -MC group (22.9 d, P = 0.003) at 13 years.CONCLUSION: MCs were not found to be negatively associated with long-term pain, disability, or sick leave. Rather, the study found that LBP patients with MCs had significantly less disability and sick-leave at long-term follow-up. We encourage further studies to elucidate these findings.LEVEL OF EVIDENCE: 2.

BACKGROUND CONTEXT Degenerative spondylolisthesis (DS) is a common condition in the elderly population which is associated with significant morbidity and decreased quality of life. For patients where pain and disability are unacceptable, surgical intervention with lumbar decompression is a commonly used treatment option, shown to provide relief of symptoms and pain. Few studies have examined if a clinically relevant difference in function is obtained, and whether this effect is sustained at long term. PURPOSE The aim of this study was to evaluate patient reported outcomes and whether patients obtain a clinically relevant improvement after surgery, and if the effect of treatment is sustained at 1, 2 and 5 years postoperatively. STUDY DESIGN/SETTING The study was performed as a retrospective cohort study on patients who underwent surgery at the Spine Centre of Southern Denmark, Middelfart, the Regional Hospital of Silkeborg and University Hospital of Zealand in Koge. PATIENT SAMPLE A total of 1,241 patients had surgery for LSS with DS during the inclusion period. All patients underwent decompression and non-instrumented fusion. We had follow-up data available on our main outcome measure (ODI) on 79.8% at 1 year, 74.8% at 2 year, and 74.2% at 5-year follow-up. OUTCOME MEASURES Oswestry Disability Index (ODI), EuroQoL-5D-3L (EQ-5D), Visual Analogue Scale Leg Pain (VAS-leg) and Visual Analogue Scale Back Pain (VAS-back). METHODS The study was performed as a multicentre registry-based retrospective cohort study using data collected prospectively in the Danish national surgical spine database; DaneSpine. In DaneSpine, patient reported outcomes are collected preoperatively, and 1, 2,5 and 10 years postoperative. This study evaluates both preoperative and postoperative outcomes. Data was collected via patient reported questionnaires, all PRO measures were filled out preoperatively and at 1, 2 and 5 years postoperatively. Based on the outcome measures, the patients who obtained a minimal clinically relevant difference in outcome (MCID) were identified at 1, 2 and 5 years postsurgery. RESULTS We found a mean change from 1 to 5 years of -20.9 on ODI; a mean change of 0.22 on EQ.5D, 30.5 on VAS leg and 20.6 on VAS back. We found that 90% of patients obtained a clinically relevant increase in one or more PROs. Apart from VAS back, there was no statistical difference in percentage of patients who obtained MCID at 1, 2 and 5-years postsurgery. CONCLUSIONS Surgery for LSS with DS has favorable results, with most patients experiencing a clinically important change in outcome measures that is maintained for at least 5 years. Of the patients who undergo surgery for LSS with DS, 90% can expect a meaningful change in outcome measures on at least one parameter. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

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.

BACKGROUND CONTEXT Back pain is the leading global cause of disability. Some studies have shown that Modic changes (MC) are strongly associated with low back pain (LBP) compared to disc degeneration alone. However, the long-term consequences in terms of patient-reported outcomes (PROs) have not been reported. This study evaluated if MC is associated with long-term disability and pain. PURPOSE The purpose of this study is to evaluate if patients with Modic changes have worse long-term outcomes compared to patients without. STUDY DESIGN/SETTING Longitudinal prospective follow-up study of a consecutive cohort of patients with chronic low back pain PATIENT SAMPLE A total of 207 patients with chronic low back pain. OUTCOME MEASURES Back- and leg pain (0–10), Roland-Morris Disability Questionnaire (RMDQ) and inflammatory pain pattern (IPP). METHODS In 2002, 207 patients with chronic low back pain were enrolled in an RCT comparing cognitive training with physical therapy. Inclusion criteria were age 18-60, almost daily LBP of ≥4 for more than four months in the past year. In 2017, these patients were then asked to complete the same PROs collected at baseline: back and leg pain (0–10), Roland-Morris Disability Questionnaire (RMDQ) and Inflammatory painpattern (IPP). Patients were then stratified based on the presence or absence of MC on their initial low-Tesla MRI. RESULTS Of the 204 cases with MRIs in 2002, 82 (40%) had MC in a least one lumbar segment. In 2017, 167 cases (82%) were available for follow-up including 65 (39%) with MC. There were no differences in demographics, smoking status, back- or leg-pain, or IPP scores at baseline and at 13-year follow-up between patients with and without MC. RMDQ was similar in both groups at baseline but worse in patients without MC at follow-up. CONCLUSIONS Various population-based studies have shown that a higher fraction of people with MC have LBP than those without. However, the current study showed that even patients without MC who had pain and were referred to a back clinic have the same clinical presentation as patients with MC. Patients with MC thus seemed to fare similar to patients without MC. However, LBP patients with MC had less long-term disability compared to LBP patients without.

BACKGROUND CONTEXT Multiple MRI classifications are used to assess lumbar degenerative disease. The most widely used are the Pfirmann classification, the presence or absence of Modic change (MC) and the Fujiwara classification of facet joint degeneration. PURPOSE The purpose of this study was to examine the associations between long-term RMDQ and baseline Pfirmann classification, Modic changes (MC) and Fujiwara classification. STUDY DESIGN/SETTING Longitudinal observational cohort study with 13-year follow-up. PATIENT SAMPLE Sample n=204 patients with chronic low back pain. OUTCOME MEASURES Primary outcome: Roland-Morris Disability Questionnaire (RMDQ) at baseline and 13-years after the MRI. METHODS In 2004-2005, patients aged 18-60 with daily LBP were enrolled in an RCT and lumbar MRI was performed. Patients completed the Roland-Morris Disability Questionnaire (RMDQ) at baseline and 13 years after the MRI. We performed a linear regression to determine associations with long-term disability (13-yr RMDQ). The MRI parameters included baseline disc degeneration (Pfirmann grade >3 on any lumbar level), Modic changes and facet joint degeneration (Fujiwara grade >2 on any lumbar level). Demographic variables at baseline included BMI, alcohol consumption, smoking and weekly physical activity. RESULTS Of 204 cases with baseline MRI, 170 (83%) were available for follow-up. Eighty-eight had disc degeneration (52%), 67 had MC (39%) and 86 had facet joint degeneration (81%). The presence of MC was the only radiologic finding that was statistically significantly associated with better 13-year RMDQ scores (p=0.003). Baseline disc degeneration and the presence of facet joint degeneration showed no significant association with 13-year disability. Baseline weekly physical activity was also significantly associated with better 13-year RMDQ scores (p CONCLUSIONS Presence of MC and weekly physical activity was significantly associated with less long-term disability. Baseline MRI findings of disc degeneration and facet joint degeneration were not associated with long-term disability. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.