Surgery for degenerative cervical myelopathy in patients with rheumatoid arthritis and ankylosing spondylitis: a nationwide registry-based study with patient-reported outcomes.

PURPOSE: To compare patient-reported outcomes (PROMs) following surgery for degenerative cervical myelopathy (DCM) among patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS) versus those without rheumatic diseases. METHODS: Data were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in the Neck Disability Index (NDI) at 1 year. Secondary endpoints included the European Myelopathy Score (EMS), quality of life (EuroQoL-5D [EQ-5D]), numeric rating scales (NRS) for headache, neck pain, and arm pain, and complications. RESULTS: Among 905 participants operated between 2012 and 2018, 35 had RA or AS. There were significant improvements in all PROMs at 1 year and no statistically significant difference between the cohorts in mean change in NDI (- 0.64, 95% CI - 8.1 to 6.8, P = .372), EQ-5D (0.10, 95% CI - 0.04 to 0.24, P = .168), NRS neck pain (- 0.8, 95% CI - 2.0 to 0.4, P = .210), NRS arm pain (- 0.6, 95% CI - 1.9 to 0.7, P = .351), and NRS headache (- 0.5, 95% CI - 1.7 to 0.8, P = .460). DISCUSSION AND CONCLUSION: Our study adds to the limited available evidence that surgical treatment cannot only arrest further progression of myelopathy but also improve functional status, neurological outcomes, and quality of life in patients with rheumatic disease.

Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial.

Importance: The use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking. Objective: To investigate the efficacy of spinal cord burst stimulation, which involves the placement of an implantable pulse generator connected to electrodes with leads that travel into the epidural space posterior to the spinal cord dorsal columns, in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders. Design, Setting, and Participants: This placebo-controlled, crossover, randomized clinical trial in 50 patients was conducted at St Olavs University Hospital in Norway, with study enrollment from September 5, 2018, through April 28, 2021. The date of final follow-up was May 20, 2022. Interventions: Patients underwent two 3-month periods with spinal cord burst stimulation and two 3-month periods with placebo stimulation in a randomized order. Burst stimulation consisted of closely spaced, high-frequency electrical stimuli delivered to the spinal cord. The stimulus consisted of a 40-Hz burst mode of constant-current stimuli with 4 spikes per burst and an amplitude corresponding to 50% to 70% of the paresthesia perception threshold. Main Outcomes and Measures: The primary outcome was difference in change from baseline in the self-reported Oswestry Disability Index (ODI; range, 0 points [no disability] to 100 points [maximum disability]; the minimal clinically important difference was 10 points) score between periods with burst stimulation and placebo stimulation. The secondary outcomes were leg and back pain, quality of life, physical activity levels, and adverse events. Results: Among 50 patients who were randomized (mean age, 52.2 [SD, 9.9] years; 27 [54%] were women), 47 (94%) had at least 1 follow-up ODI score and 42 (84%) completed all stimulation randomization periods and ODI measurements. The mean ODI score at baseline was 44.7 points and the mean changes in ODI score were -10.6 points for the burst stimulation periods and -9.3 points for the placebo stimulation periods, resulting in a mean between-group difference of -1.3 points (95% CI, -3.9 to 1.3 points; P = .32). None of the prespecified secondary outcomes showed a significant difference. Nine patients (18%) experienced adverse events, including 4 (8%) who required surgical revision of the implanted system. Conclusions and Relevance: Among patients with chronic radicular pain after lumbar spine surgery, spinal cord burst stimulation, compared with placebo stimulation, after placement of a spinal cord stimulator resulted in no significant difference in the change from baseline in self-reported back pain-related disability. Trial Registration: ClinicalTrials.gov Identifier: NCT03546738.

Surgery for degenerative cervical myelopathy in the elderly: a nationwide registry-based observational study with patient-reported outcomes.

BACKGROUND: The aim of this study was to investigate whether clinical outcomes in patients aged ≥ 70 undergoing decompressive surgery for degenerative cervical myelopathy (DCM) differ from those of younger patients (50-70 years) at 1 year. METHODS: Data were obtained from the Norwegian Registry for Spine Surgery (NORspine). Among 651 patients included, 177 (27.2%) were ≥ 70 years old. The primary outcome was change in the Neck Disability Index (NDI). Secondary outcomes were changes in the European Myelopathy Score (EMS), quality of life (EuroQoL EQ-5D), numeric rating scales (NRS) for headache, neck pain, and arm pain, and complications. RESULTS: Significant improvements in all patient-reported outcomes (PROMs) were detected for both age cohorts at 1 year. For the two age cohorts combined, there was a statistically significant improvement in the NDI score (mean 9.2, 95% CI 7.7 to 10.6, P < 0.001). There were no differences between age cohorts in mean change of NDI (- 8.9 vs. - 10.1, P = 0.48), EQ-5D (0.13 vs. 0.17, P = 0.37), or NRS pain scores, but elderly patients experienced a larger improvement in EMS (0.7 vs. 1.3, P = 0.02). A total of 74 patients (15.6%) in the younger cohort and 43 patients (24.3%) in the older cohort experienced complications or adverse effects within 3 months of surgery, mainly urinary and respiratory tract infections. CONCLUSION: Surgery for DCM was associated with significant improvement across a wide range of PROMs for both younger and elderly patients. Surgery for DCM should not be denied based on age alone.

Persistent Use of Prescription Opioids Following Lumbar Spine Surgery: Observational Study with Prospectively Collected Data From Two Norwegian Nationwide Registries.

STUDY DESIGN: Prospective pharmacoepidemiological study. OBJECTIVE: To investigate the use of prescription opioids 2 years following degenerative lumbar spine surgery. SUMMARY OF BACKGROUND DATA: There are limited data providing details to evaluate patterns of opioid use. The number of patients is often limited and data on opioid use following some of the most common surgical procedures are lacking. METHODS: Data from the Norwegian Registry for Spine Surgery and the Norwegian Prescription Database were linked on an individual level. The primary outcome measure was persistent opioid use the second year after surgery. Functional disabilitywas measured with the Oswestry disability index (ODI). Study participants were operated between 2007 and 2017. RESULTS: Among 32,886 study participants, 2754 (8.4%) met criteria for persistent opioid use the second year after surgery. Among persistent opioid users in the second year after surgery, 64% met the criteria for persistent opioid use the year preceding surgery. Persistent opioid use the year preceding surgery (odds ratio [OR] 31.10, 95% confidence interval [CI] 26.9-36.0, P  = 0.001), use of high doses of benzodiazepines (OR 1.62, 95% CI 1.30-2.04, P  = 0.001), and use of high doses of z-hypnotics (OR 1.90, 95% CI 1.58-2.22, P  = 0.001) the year before surgery were associated with increased risk of persistent opioid use the second year after surgery. A higher ODI score at 1 year was observed in persistent opioid users compared with non-persistent users (41.5 vs. 18.8 points) and there was a significant difference in ODI change (-13.7 points). Patients with persistent opioid use in the year preceding surgery were less likely to achieve a minimal clinically important ODI change at 1 year compared with non-persistent users (37.7% vs. 52.6%, P  = 0.001). CONCLUSION: Patients with or at risk of developing persistent opioid should be identified and provided counseling and support to taper off opioid treatment.Level of Evidence: 2.

Pain During Sex Before and After Decompressive Surgery for Lumbar Spinal Stenosis: A Multicenter Observational Study.

STUDY DESIGN: Observational multicenter study. OBJECTIVE: The aim of this study was to evaluate changes in pain during sexual activity after surgery for lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND DATA: There are limited data available on sexual function in patients undergoing surgery for LSS. METHODS: Data were retrieved from the Norwegian Registry for Spine Surgery. The primary outcome was change in pain during sexual activity at 1 year, assessed by item number eight of the Oswestry disability index questionnaire. Secondary outcome measures included Oswestry Disability Index, EuroQol-5D, and numeric rating scale scores for back and leg pain. RESULTS: Among the 12,954 patients included, 9908 (76.5%) completed 1-year follow-up. At baseline 9579 patients (73.9%) provided information about pain during sexual activity, whereas 7424 (74.9%) among those with complete follow-up completed this item. Preoperatively 2528 of 9579 patients (26.4%) reported a normal sex-life without pain compared with 4294 of 7424 patients (57.8%) at 1 year. Preoperatively 1007 (10.5%) patients reported that pain prevented any sex-life, compared with 393 patients (5.3%) at 1 year. At baseline 7051 of 9579 patients (73.6%) reported that sexual activity caused pain, and among these 3145 of 4768 responders (66%) reported an improvement at 1 year. A multivariable regression analysis showed that having a life partner, college education, and working until time of surgery were predictors of improvement in pain during sexual activity. Current tobacco smoking, pain duration >12 months, previous spine surgery, and complications occurring within 3 months were negative predictors. CONCLUSION: This study clearly demonstrates that a large proportion of patients undergoing surgery for LSS experienced an improvement in pain during sexual activity at 1 year.Level of Evidence: 2.

Surgery for Degenerative Cervical Myelopathy: A Nationwide Registry-Based Observational Study With Patient-Reported Outcomes.

BACKGROUND: Indications and optimal timing for surgical treatment of degenerative cervical myelopathy (DCM) remain unclear, and data from daily clinical practice are warranted. OBJECTIVE: To investigate clinical outcomes following decompressive surgery for DCM. METHODS: Data were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in the neck disability index (NDI) 1 yr after surgery. Secondary endpoints were the European myelopathy score (EMS), quality of life (EuroQoL 5D [EQ-5D]), numeric rating scales (NRS) for headache, neck pain, and arm pain, complications, and perceived benefit of surgery assessed by the Global Perceived Effect (GPE) scale. RESULTS: We included 905 patients operated between January 2012 and June 2018. There were significant improvements in all patient-reported outcome measures (PROMs) including NDI (mean -10.0, 95% CI -11.5 to -8.4, P < .001), EMS (mean 1.0, 95% CI 0.8-1.1, P < .001), EQ-5D index score (mean 0.16, 95% CI 0.13-0.19, P < .001), EQ-5D visual analogue scale (mean 13.8, 95% CI 11.7-15.9, P < .001), headache NRS (mean -1.1, 95% CI -1.4 to -0.8, P < .001), neck pain NRS (mean -1.8, 95% CI -2.0 to -1.5, P < .001), and arm pain NRS (mean -1.7, 95% CI -1.9 to -1.4, P < .001). According to GPE scale assessments, 229/513 patients (44.6%) experienced "complete recovery" or felt "much better" at 1 yr. There were significant improvements in all PROMs for both mild and moderate-to-severe DCM. A total of 251 patients (27.7%) experienced adverse effects within 3 mo. CONCLUSION: Surgery for DCM is associated with significant and clinically meaningful improvement across a wide range of PROMs.

Adiposity and Physical Activity as Risk Factors for Developing Psoriatic Arthritis: Longitudinal Data From a Population-Based Study in Norway.

OBJECTIVE: Adiposity is prevalent among patients with psoriatic arthritis (PsA). However, the temporal relation is unclear. The present study was undertaken to investigate whether adiposity and body fat distribution are related to the risk of developing PsA, and whether physical activity could modify the possible risk. METHODS: We included 36,626 women and men from the Norwegian Nord-Trøndelag Health Study without diagnosed PsA at baseline from 1995 to 1997. Cox regression analysis was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (95% CIs) of incident PsA at follow-up from 2006 to 2008. RESULTS: During follow-up, 185 new cases of PsA were reported. Increases of 1 SD in body mass index (BMI) (4.2 and 3.5 kg/m2 for women and men, respectively) and waist circumference (10.8 and 8.6 cm, respectively) were associated with HRs of 1.40 (95% CI 1.24, 1.58) and 1.48 (95% CI 1.31, 1.68), respectively. Compared to individuals of normal weight, obese individuals had an HR of 2.46 (95% CI 1.65, 3.68), and overweight individuals had an HR of 1.41 (95% CI 1.00, 1.99). Comparing extreme quartiles of waist circumference yielded an HR of 2.63 (95% CI 1.73, 3.99). In analyses of combined effects using a BMI of <25 kg/m2 and high physical activity as reference, a BMI of ≥25 kg/m2 was associated with HRs of 2.06 (95% CI 1.18, 3.58) and 1.53 (95% CI 0.80, 2.91) among those with low and high physical activity levels, respectively. Corresponding HRs for high waist circumference and physical activity were 2.25 (95% CI 1.40, 1.63) and 1.85 (95% CI 0.95, 3.50). CONCLUSION: The results suggest that adiposity, particularly central obesity, is associated with increased risk of incident PsA. Although there was no clear modifying effect of physical activity, high levels of physical activity reduced the risk of PsA, regardless of BMI.

Risk of intracranial hemorrhage (RICH) in users of oral antithrombotic drugs: Nationwide pharmacoepidemiological study.

BACKGROUND: The risks of intracranial haemorrhage (ICH) associated with antithrombotic drugs outside clinical trials are gaining increased attention. The aim of this nationwide study was to investigate the risk of ICH requiring hospital admission in users of antithrombotic drugs. METHODS AND FINDINGS: Data from the Norwegian Patient Registry and Norwegian Prescription Database were linked on an individual level. The primary outcome was incidence rates of ICH associated with use of antithrombotic drugs. Secondary endpoints were risk of ICH and fatal outcome following ICH assessed by Cox models. Among 3,131,270 individuals ≥18 years old observed from 2008 through 2014, there were 729,818 users of antithrombotic medications and 22,111 ICH hospitalizations. Annual crude ICH rates per 100 person-years were 0.076 (95% CI, 0.075-0.077) in non-users and 0.30 (95% CI, 0.30-0.31) in users of antithrombotic medication, with the highest age and sex adjusted rates observed for aspirin-dipyridamole plus clopidogrel (0.44; 95% CI, 0.19-0.69), rivaroxaban plus aspirin (0.36; 95% CI, 0.16-0.56), warfarin plus aspirin (0.34; 95% CI, 0.26-0.43), and warfarin plus aspirin and clopidogrel (0.33; 95% CI, 0.073-0.60). With no antithrombotic medication as reference, the highest adjusted hazard ratios (HR) for ICH were observed for aspirin-dypiridamole plus clopidogrel (6.29; 95% CI 3.71-10.7), warfarin plus aspirin and clopidogrel (4.38; 95% CI 2.71-7.09), rivaroxaban plus aspirin (3.82; 95% CI, 2.46-5.95), and warfarin plus aspirin (3.40; 95% CI, 2.99-3.86). All antithrombotic medication regimens were associated with an increased risk of ICH, except dabigatran monotherapy (HR 1.20; 95% CI, 0.88-1.65) and dabigatran plus aspirin (HR 1.79; 95% CI, 0.96-3.34). Fatal outcome within 90 days was more common in users (2,603 of 8,055) than non-users (3,228 of 14,056) of antithrombotic medication (32.3% vs 23.0%, p<0.001), and was associated with use of warfarin plus aspirin and clopidogrel (HR 2.89; 95% CI, 1.49-5.60), warfarin plus aspirin (HR 1.37; 95% CI, 1.11-1.68), aspirin plus clopidogrel (HR 1.30; 95% CI, 1.05-1.61), and warfarin (HR 1.19; 95% CI, 1.09-1.31). Increased one-year mortality was observed in users of antithrombotic medication following hemorrhagic stroke, subdural hemorrhage, subarachnoid hemorrhage, and traumatic ICH (all p<0.001). Limitations include those inherent to observational studies including the inability to make causal inferences, certain assumptions regarding drug exposure, and the possibility of residual confounding. CONCLUSIONS: The real-world incidence rates and risks of ICH were generally higher than reported in randomized controlled trials. There is still major room for improvement in terms of antithrombotic medication safety (clinicaltrials.gov NCT02481011).

Surgery for Lumbar Spinal Stenosis in Individuals Aged 80 and Older: A Multicenter Observational Study.

OBJECTIVES: To compare clinical outcomes after decompressive surgery for central lumbar spinal stenosis (LSS) in individuals aged 80 and older with those of individuals aged 18-79. DESIGN: Prospective data from the Norwegian Registry for Spine Surgery. SETTING: Multicenter observational study. PARTICIPANTS: Individuals with central LSS undergoing surgery at 36 orthopedic or neurosurgical departments (N = 1,503; 1,325 aged <80 (median 66, range 21-79); 178 aged ≥80 (median 82, range 80-95)). INTERVENTION: Laminectomy or microdecompression. MEASUREMENTS: Changes in Oswestry Disability Index (ODI), EuroQol 5D (EQ-5D), back pain numerical rating scale (NRS), and leg pain NRS at 1 year. Complications and duration of surgical procedures and hospital stays are reported. RESULTS: For all participants, there was a significant improvement in ODI (difference 16.60 points, 95% confidence interval (CI) = 15.59-17.61, P < .001). There were no differences between age cohorts in mean changes in ODI (0.2, 95% CI = -3.05-3.39, P = .92), EQ-5D (0.02, 95% CI = -0.04-0.09, P = .49), back pain NRS (-0.2, 95% CI = -0.7-0.4, P = .56), or leg pain NRS (-0.1, 95% CI = -0.7-0.5), P = .77). There were no differences in perioperative complications between age cohorts (4.9% vs 7.9%, P = .11). Participants aged 80 and older reported more complications occurring within 3 months (11.8% vs 7.5%, P = .02), mainly because of more urinary tract infections (9.6% vs 3.5%, P = .001). Mean duration of hospital stays was 1.3 days longer for participants aged 80 and (4.5 vs 3.2 days, P < .001). There were no differences in duration of single-level microdecompression (P = .94), two-level microdecompression (P = .53), single-level laminectomy (P = .78), or two-level laminectomy (P = .08). CONCLUSION: Individuals aged 80 and older experience improvement in self-reported outcomes similar to those of younger individuals after decompressive surgery for LSS.

Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study.

Background A wide range of antithrombotic medications can be used in the prevention and treatment of thrombosis. Among hemorrhagic complications of antithrombotic drugs, intracranial hemorrhage may have particularly devastating consequences with high morbidity, disability and mortality rates. The incidence and risks of intracranial hemorrhage in patients on antithrombotic treatments from regular clinical practice outside clinical trials remain largely unknown. It is not known if results from clinical trials can be extrapolated to everyday clinical practice. We will conduct a nationwide study to investigate the risks and incidence rates of intracranial hemorrhage in users oral antithrombotic drugs in Norway from 2008 through 2014.   Methods and design The aim of this nationwide study is to investigate the incidence rates of intracranial hemorrhage requiring hospitalization in users of oral antithrombotic drugs. The study will be conducted within the approximately 4.7 million inhabitants of Norway from January 1 (st), 2008, to December 31 (st), 2014. Treatment and outcome data are obtained from the Norwegian patient registry and the Norwegian prescription database.   Trial registration number Clinicaltrials.gov (NCT02481011).