Return to work after surgery for degenerative cervical myelopathy: a nationwide registry-based observational study.

BACKGROUND: Few studies of high quality exist on return to work (RTW) rate after surgery for degenerative cervical myelopathy (DCM). This study aims to examine the RTW rate in patients undergoing surgery for DCM. METHODS: Nationwide prospectively collected data were obtained from the Norwegian Registry for Spine Surgery and the Norwegian Labour and Welfare Administration. The primary outcome was return to work, defined as being at work at a given time postoperatively without any medical income-compensation benefits. Secondary endpoints included the neck disability index (NDI) and quality of life measured by EuroQol-5D (EQ-5D). RESULTS: Among 439 patients operated for DCM between 2012 and 2018, 20% of the patients received a medical income-compensation benefit one year before surgery. This number increased steadily towards the operation at which timepoint 100% received benefits. By 12 months after surgery, 65% had returned to work. By 36 months, 75% had returned to work. Patients that returned to work were more likely to be non-smokers and to have a college education. They had less comorbidity, more were without benefit 1-year pre-surgery, and significantly more patients were employed at operation date. Average days of sick leave in the year before surgery were significantly less in the RTW group, and they had a significantly lower baseline NDI and EQ-5D All PROMs reached statistical significance at 12 months, in favor of the group that achieved RTW. CONCLUSION: At 12 months following surgery, 65% had returned to work. At the end of the 36-month follow-up period, 75% had returned to work, 5% less than the working percentage in the beginning of the follow-up period. This study demonstrates that a large percentage of patients return to work after surgical treatment for DCM.

Effect of Arthroplasty vs Fusion for Patients With Cervical Radiculopathy: A Randomized Clinical Trial.

Importance: Surgical treatment for cervical radiculopathy is increasing. Treatment with motion preserving anterior cervical disc arthroplasty was introduced to prevent symptomatic adjacent segment disease, and there is need to evaluate results of this treatment compared with standard anterior cervical discectomy and fusion. Objective: To investigate clinical outcomes at 5 years for arthroplasty vs fusion in patients who underwent surgical treatment for cervical radiculopathy. Design, Setting, and Participants: This multicenter, single-blinded, randomized clinical trial included patients aged 25 to 60 years with C6 or C7 radiculopathy referred to study sites' outpatient clinics from 2008 to 2013. Data were analyzed from December 2019 to December 2020. Interventions: Patients were randomly assigned to arthroplasty or fusion. Patients were blinded to which treatment they received. The surgical team was blinded until nerve root decompression was completed. Main Outcomes and Measures: The primary end point was change in Neck Disability Index (NDI) score. Secondary outcomes were arm and neck pain, measured with numeric rating scales (NRS); quality of life, measured with the EuroQol-5D (EQ-5D); reoperation rates; and adjacent segment disease. Results: Among 147 eligible patients, 4 (2.7%) declined to participate and 7 (4.8%) were excluded. A total of 136 patients were randomized (mean [SD] age, 44.1 [7.0] years; 73 (53.7%) women), with 68 patients randomized to arthroplasty and 68 patients randomized to fusion. A total of 114 patients (83.8%) completed the 5-year follow-up. In the arthroplasty group, the mean NDI score was 45.9 (95% CI, 43.3 to 48.4) points at baseline and 22.2 (95% CI, 18.0 to 26.3) points at 5 years follow-up, and in the fusion group, mean NDI score was 51.3 (95% CI, 48.1 to 54.4) points at baseline, and 21.3 (95% CI, 17.0 to 25.6) points at 5 years follow-up. The changes in mean NDI scores between baseline and 5 years were statistically significant for arthroplasty (mean change, 24.8 [95% CI, 19.8 to 29.9] points; P < .001) and fusion (mean change, 29.9 [95% CI, 24.0 to 35.9] points; P < .001), but the change in mean NDI scores was not significantly different between groups (difference, 5.1 [95% CI, -2.6 to 12.7] points; P = .19). There were no significant differences in changes in arm pain (mean [SE] change, 3.5 [0.5] vs 3.1 [0.4]; P = .47), neck pain (mean [SE] change, 3.0 [0.5] vs 3.4 [0.5]; P = .50), EQ-5D (mean [SE] change, 0.39 [0.4] vs 0.45 [0.6]; P = .46), patients requiring reoperation (10 patients [14.7%] vs 8 patients [11.8%]; P = .61), and adjacent segment disease (0 patients vs 1 patient [1.5%]; P = .32) between the arthroplasty and fusion groups. Conclusions and Relevance: In this randomized clinical trial, patients treated with arthroplasty and fusion reported similar and substantial clinical improvement at 5 years. Trial Registration: ClinicalTrials.gov Identifier: NCT00735176.

Low Back Pain With Persistent Radiculopathy; the Clinical Role of Genetic Variants in the Genes SOX5, CCDC26/GSDMC and DCC.

In a recently published genome-wide association study (GWAS) chronic back pain was associated with three loci; SOX5, CCDC26/GSDMC and DCC. This GWAS was based on a heterogeneous sample of back pain disorders, and it is unknown whether these loci are of clinical relevance for low back pain (LBP) with persistent radiculopathy. Thus, we examine if LBP with radiculopathy 12 months after an acute episode of LBP with radiculopathy is associated with the selected single nucleotide polymorphisms (SNPs); SOX5 rs34616559, CCDC26/GSDMC rs7833174 and DCC rs4384683. In this prospective cohort study, subjects admitted to a secondary health care institution due to an acute episode of LBP with radiculopathy, reported back pain, leg pain, and Oswestry Disability Index (ODI), were genotyped and followed up at 12 months (n = 338). Kruskal-Wallis H test showed no association between the SNPs and back pain, leg pain or ODI. In conclusion, LBP with radiculopathy 12 months after an acute episode of LBP with radiculopathy, is not associated with the selected SNPs; SOX5 rs34616559, CCDC26/GSDMC rs7833174 and DCC rs4384683. This absent or weak association suggests that the SNPs previously associated with chronic back pain are not useful as prognostic biomarkers for LBP with persistent radiculopathy.

Clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - secondary analyses of a randomised, placebo-controlled trial (the AIM study).

BACKGROUND: Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. METHODS: We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0-24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. RESULTS: None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was - 4.0 (95%CI, - 6.9 to - 1.2), compared to - 0.5 (95%CI, - 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). CONCLUSIONS: We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT02323412 , First registered 23 December 2014.

Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial.

OBJECTIVE: To assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes). DESIGN: Double blind, parallel group, placebo controlled, multicentre trial. SETTING: Hospital outpatient clinics at six hospitals in Norway. PARTICIPANTS: 180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017. INTERVENTIONS: Patients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription. MAIN OUTCOME MEASURES: The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4. RESULTS: In the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was -1.6 (95% confidence interval -3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was -2.3 (-4.2 to-0.4, P=0.02) for patients with type 1 Modic changes and -0.1 (-2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group. CONCLUSIONS: In this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02323412.

Impact of 2015 earthquakes on a local hospital in Nepal: A prospective hospital-based study.

INTRODUCTION: Natural disasters pose a great challenge to the health systems and individual health facilities. In low-resource settings, disaster preparedness systems are often limited and not been well described. Two devastating earthquakes hit Nepal within a 17-days period in 2015. This study aims to describe the burden and distribution of emergency cases to a local hospital. METHODS: This is a prospective observational study of patients presenting to a local hospital for a period of 21 days following the earthquake on April 25, 2015. Demographic and clinical information was prospectively registered for all patients in the systematic emergency registry. Systematic telephone interviews were conducted in a random sample of the patients 90 days after admission to the hospital. RESULTS: A total of 2,003 emergency patients were registered during the period. The average daily number of emergency patients during the first five days was almost five times higher (n = 150) than the pre-incident daily average (n = 35). The majority of injuries were fractures (58%), 348 (56%) in the lower extremities. A total of 345 surgical procedures were performed and the hospital treated 111 patients with severe injuries related to the earthquake (compartment syndrome, crush injury, and internal injury). Among those with follow-up interviews, over 90% reported that they had been severely affected by the earthquakes; complete house damage, living in temporary shelter, or loss of close family member. CONCLUSION: The hospital experienced a very high caseload during the first days, and the majority of patients needed orthopaedic services. The proportion of severely injured and in-hospital deaths were relatively low, probably indicating that the most severely injured did not reach the hospital in time. The experiences underline the need for robust and easily available local health services that can respond to disasters.

Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.

BACKGROUND: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months' follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers. METHODS/DESIGN: A double-blinded RCT is conducted at six hospitals in Norway, comparing orally administered amoxicillin 750 mg, or placebo three times a day, over a period of 100 days in patients with chronic LBP and type I or II MCs at the level of a MRI-confirmed lumbar disc herniation within the preceding 2 years. The inclusion will be stopped when at least 80 patients are included in each of the two MC type groups. In each MC type group, the study is designed to detect (ß = 0.1, α = 0.05) a mean difference of 4 (standard deviation 5) in the Roland Morris Disability Questionnaire score between the two treatment groups (amoxicillin or placebo) at 1-year follow-up. The study includes cost-effectiveness measures. Blood samples are assessed for security measures and for possible inflammatory mediators and biomarkers at different time points. MCs are evaluated on MRI at baseline and after 12 months. A blinded intention-to-treat analysis of treatment effects will be performed in the total sample and in each MC type group. DISCUSSION: To ensure the appropriate use of antibiotic treatment, its effect in chronic LBP patients with MCs should be re-assessed. This study will investigate the effects and cost-effectiveness of amoxicillin in patients with chronic LBP and MCs at the level of a disc herniation. The study may also help to refine imaging and characterise the biomarkers of MCs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02323412 . Registered on 21 November 2014.

Incidence rates and surgery of primary intraspinal tumors in the era of modern neuroimaging: a national population-based study.

STUDY DESIGN: Prospective national population-based cohort study. OBJECTIVE: To evaluate national population-based data on histopathologically verified intraspinal tumors and explore time trends in incidence and surgery rates and associations with the increased availability of magnetic resonance imaging (MRI) during 1993 and 2011. SUMMARY OF BACKGROUND DATA: There is a relative lack of updated epidemiological data on primary intraspinal tumors and most previous studies do not capture the advances in diagnostics and surgical treatment in the era of modern neuroimaging. The possible effect of the increasing availability of MRI on incidence rates and clinical management of primary intraspinal tumors is not known. METHODS: We included all patients with a histologically verified intraspinal tumor diagnosed between 1993 and 2011 in a population-based cohort based on data from the Cancer Registry of Norway. The incidence and surgery rates were calculated and compared with the number of available MRI scanners in Norway. RESULTS: We identified 1104 patients diagnosed with a primary intraspinal tumor. The incidence rate based on the Norwegian population between 1993 and 2011 was 1.28 per 100,000. In 1993, there were 8 MRI scanners in Norway increasing to 125 in 2011. There seems to be a plateau in the increase in incidence rates after 2002 where the subsequent increase in the number of MRI scanners did not seem to be followed by further increases of intraspinal tumor surgery. CONCLUSION: The incidence rate of primary intraspinal tumors in Norway changed dramatically during the study period, stabilizing around 1.5 per 100,000 per year since 2002. There was an increase in surgery for all major subgroups. This increase in surgical activity seems to correlate with the simultaneous large increase in the availability of diagnostic magnetic resonance imaging.

Utilization of a civilian academic center as a force multiplier in support of NATO special operations medicine - a pilot demonstration.

This work describes a NATO-university telemedicine collaboration established to perform a teleneurosurgery consult to assist a deployed soldier with a spinal cord injury.

Clinical characteristics, pain, and disability in relation to alar ligament MRI findings.

STUDY DESIGN: Cross-sectional study. OBJECTIVE: To evaluate the association between degree of signal changes in the alar ligaments on MRI with respect to pain and disability. SUMMARY OF BACKGROUND DATA: Conflicting evidence exists whether areas of high-signal intensity in the alar ligaments on MRI are associated with pain and disability. METHODS: A cross-sectional designed study of 173 subjects including a group with persistent whiplash associated disorder (WAD) Grade II after a car accident (n = 59), a group with chronic nontraumatic neck pain (n = 57) and a group without neck pain or previous neck trauma (n = 57). To assess pain and disability, all participants filled in the Brief Pain Inventory (BPI-intensity and BPI-interference), the European Quality of Life (EQ-5D and EQ VAS) and the Hospital Anxiety and Depression Rating Scale (HADS). High-resolution proton-weighted MR images in three planes were evaluated by two experienced neuroradiologists who were blinded to patient history and group allocation. The alar ligaments were evaluated according to a 4-point grading scale; 0 = low-signal intensity throughout the entire cross-section area, 1 = high-signal intensity in one third or less, 2 = high-signal intensity in one third to two thirds, and 3 = high-signal intensity in two thirds or more of the cross-section area. RESULTS: With respect to BPI and HADS, the scores were highest in the WAD group, intermediate in the chronic nontraumatic neck pain group, and lowest among controls. EuroQol scores were lowest in the WAD group, intermediate in the chronic nontraumatic neck pain group, and highest among controls (P < 0.001). There was, however, no significant correlation between the alar ligament changes and measures for pain and disability. CONCLUSION: The previously reported assumption that changes in the alar ligaments detected on MRI are associated with pain and disability is not supported by this study. The diagnostic value and the clinical relevance of MR-detectable areas of high intensity in the alar ligaments remain questionable.

Magnetic resonance imaging assessment of the alar ligaments in whiplash injuries: a case-control study.

STUDY DESIGN: Case-control study. OBJECTIVE: To use high-resolution magnetic resonance imaging (MRI) in assessing signal intensity areas in the alar ligaments. SUMMARY OF BACKGROUND DATA: Conflicting evidence exists whether areas of high signal intensity in the alar ligament on MRI are more frequent in whiplash patients than in noninjured control subjects. METHODS: A case-control designed study of 173 subjects included one group with persistent whiplash associated disorder Grade I-II after a car accident (n = 59), one with chronic nontraumatic neck pain (n = 57) and one group without neck pain or previous neck trauma (n = 57). High-resolution proton-weighted MRI in 3 planes was used. The images were independently evaluated by two experienced neuroradiologists who were blinded to patient history and group allocation. The alar ligaments were evaluated according to a 4-point grading scale; 0 = low signal intensity throughout the entire cross section area, 1 = high signal intensity in one third or less, 2 = high signal intensity in one-third to two thirds, and 3 = high signal intensity in two thirds or more of the cross section area. RESULTS: Alar ligament changes Grade 0 to 3 were seen in all 3 diagnostic groups. Areas of high signal intensity (Grade 2-3) were found in at least one alar ligament in 49% of the patients in the whiplash associated disorder Grade I-II group, in 33% of the chronic neck pain group and in 40% of the control group (chi, P = 0.22). CONCLUSION.: The previously reported assumption that these changes are due to a trauma itself is not supported by this study. The diagnostic value and the clinical relevance of magnetic resonance detectable areas of high intensity in the alar ligaments are questionable.