Handling of missing items in the Oswestry disability index and the neck disability index. A study from Swespine, the National Swedish spine register.

PURPOSE: The Oswestry Disability Index (ODI) and the Neck Disability Index (NDI) scoring algorithms used by the Swedish spine register (Swespine) until April 2022 handled missing items somewhat differently than the original algorithms. The purpose of the current study was to evaluate possible differences in the ODI and NDI scores between the Swespine and the original scoring algorithms. METHODS: Patients surgically treated for degenerative conditions of the lumbar or cervical spine between 2003-2019 (lumbar) and 2006-2019 (cervical) were identified in Swespine. Preoperative and 1-year postoperative ODI/NDI data were used to evaluate differences between the Swespine and the original ODI/NDI algorithms with adjustment for at most 1 or 2 missing items using mean imputation. RESULTS: The preoperative as well as the 1-year postoperative ODI/NDI were approximately 1 unit out of 100 smaller for the Swespine algorithm, irrespective of adjustment model. The differences between preoperative and postoperative ODI/NDI scores were similar between the Swespine and the original scoring algorithms. There were occasional statistically significant differences between the preoperative-postoperative differences due to large sample sizes. CONCLUSIONS: The Swespine algorithms, used until April 2022, underestimated the ODI and NDI by approximately 1 out of 100 units compared with the original algorithms. In addition, there were no statistically significant differences between the original algorithms when adjusting for at most 1 or 2 missing items. The algorithm has now been changed, also for historical data.

Prediction of outcome after spinal surgery-using The Dialogue Support based on the Swedish national quality register.

PURPOSE: To evaluate the predictive precision of the Dialogue Support, a tool for additional help in shared decision-making before surgery of the degenerative spine. METHODS: Data in Swespine (Swedish national quality registry) of patients operated between 2007 and 2019 found the development of prediction algorithms based on logistic regression analyses, where socio-demographic and baseline variables were included. The algorithms were tested in four diagnostic groups: lumbar disc herniation, lumbar spinal stenosis, degenerative disc disease and cervical radiculopathy. By random selection, 80% of the study population was used for the prediction of outcome and then tested against the actual outcome of the remaining 20%. Outcome measures were global assessment of pain (GA), and satisfaction with outcome. RESULTS: Calibration plots demonstrated a high degree of concordance on a group level. On an individual level, ROC curves showed moderate predictive capacity with AUC (area under the curve) values 0.67-0.68 for global assessment and 0.6-0.67 for satisfaction. CONCLUSION: The Dialogue Support can serve as an aid to both patient and surgeon when discussing and deciding on surgical treatment of degenerative conditions in the lumbar and cervical spine. LEVEL OF EVIDENCE: I.

[Antibiotics should not be used for treating back pain due to Modic changes].

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.

[Antibiotics should not be used to treat patients with back/leg pain]. / Antibiotika ska med dagens kunskap inte användas vid ryggvärk ­ med eller utan benvärk.

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.

Fear of Movement Is Related to Low Back Disability During a Two-Year Period in Patients Who Have Undergone Elective Lumbar Spine Surgery.

OBJECTIVE: To evaluate change in fear of movement and the relationship of fear of movement and pain intensity to low back disability and general health-related quality of life over a 2-year period. METHODS: Consecutive patients scheduled for lumbar spine surgery were included. In addition to clinical background variables, back pain intensity, fear of movement, low back disability, and general health-related quality of life were assessed at baseline, 1 year, and 2 years after surgery. Linear mixed-effects models were used to analyze data. RESULTS: In total, 348 patients were included in the final analyses. There was a significant reduction in fear of movement and a significant interaction between fear of movement and low back disability across assessments, showing that greater levels of fear of movement were related to greater levels of disability over the 2-year period. Similarly, greater levels of back pain intensity were related to lower levels of general health-related quality of life during this period. CONCLUSIONS: We found that greater levels of fear of movement were related to greater levels of low back disability, following lumbar spine surgery, in a longitudinal study. This shows the need to address fear of movement in prehabilitation/rehabilitation pre- or postsurgically to improve health outcomes for patients who undergo lumbar spine surgery.

Cost and Health Outcomes Patterns in Patients Treated With Spinal Cord Stimulation Following Spine Surgery-A Register-Based Study.

OBJECTIVE: Spinal cord stimulation (SCS), a minimally invasive treatment option for long-term neuropathic pain, has been shown to be effective in patients with persisting neuropathic pain after spine surgery. However, little is known about the long-term cost and quality-of-life (QoL) patterns in SCS-treated patients. The aim is to describe the use of SCS, costs, pre-spine-surgery and post-spine-surgery QoL, and reported pain intensity, in patients who have undergone spine surgery and subsequent SCS implantation. The results will be related to outcome and cost in spine surgery patients in general. MATERIALS AND METHODS: A research database comprised from six Swedish national and regional registers, and the spine surgery quality-of-care register Swespine was utilized. Two cohorts were identified: all patients who had spine surgery (N = 73,765) and patients who had spine surgery and subsequent SCS implantation (N = 239). Costs were analyzed before and after spine surgery for both cohorts, as well as before and after SCS implantation for the second cohort. QoL was explored by estimating patient-reported outcome measures such as pain intensity, Oswestry Disability Index, and EuroQol-5Dimensions from spine surgery up to five years post-spine surgery. RESULTS: In spine surgery patients, mean QoL and pain intensity levels improved following surgery. Patients subsequently treated with SCS had lower reported QoL and higher costs before the initial spine surgery, and spine surgery did not lead to any substantial improvements, however, costs decreased following SCS implantation in these patients.

Correction to: Bacteria: back pain, leg pain and Modic sign-a surgical multicenter comparative study.

Unfortunately, the 5th author name was incorrectly published in the original paper. The complete correct name is given below.

Surgical Treatment of Degenerative Disk Disease in Three Scandinavian Countries: An International Register Study Based on Three Merged National Spine Registers.

STUDY DESIGN: Observational study of prospectively collected data. OBJECTIVES: Patients with chronic low back pain resistant to nonoperative treatment often face a poor prognosis for recovery. The aim of the current study was to compare the variation and outcome of surgical treatment of degenerative disc disease in the Scandinavian countries based on The International Consortium for Health Outcomes Measurement core spine data sets. METHODS: Anonymized individual level data from 3 national registers were pooled into 1 database. At the time of surgery, the patient reports data on demographics, lifestyle topics, comorbidity, and data on health-related quality of life such as Oswestry Disability Index, Euro-Qol-5D, and back and leg pain scores. The surgeon records diagnosis, type of surgery performed, and complications. One-year follow-ups are obtained with questionnaires. Baseline and 1-year follow-up data were analyzed to expose any differences between the countries. RESULTS: A total of 1893 patients were included. At 1-year follow-up, 1315 (72%) patients responded. There were statistically significant baseline differences in age, smoking, comorbidity, frequency of previous surgery and intensity of back and leg pain. Isolated fusion was the primary procedure in all the countries ranging from 84% in Denmark to 76% in Sweden. There was clinically relevant improvement in all outcome measures except leg pain. CONCLUSIONS: In homogenous populations with similar health care systems the treatment traditions can vary considerably. Despite variations in preoperative variables, patient reported outcomes improve significantly and clinically relevant with surgical treatment.

Bacteria: back pain, leg pain and Modic sign-a surgical multicentre comparative study.

PURPOSE: To compare bacterial findings in pain-generating degenerated discs in adults operated on for lumbar disc herniation (LDH), and mostly also suffering from low back pain (LBP), with findings in adolescent patients with non-degenerated non-pain-generating discs operated on for scoliosis, and to evaluate associations with Modic signs on magnetic resonance imaging (MRI). Cutibacterium acnes (Propionibacterium acnes) has been found in painful degenerated discs, why it has been suggested treating patients with LDH/LBP with antibiotics. As multidrug-resistant bacteria are a worldwide concern, new indications for using antibiotics should be based on solid scientific evidence. METHODS: Between 2015 and 2017, 40 adults with LDH/LBP (median age 43, IQR 33-49) and 20 control patients with scoliosis (median age 17, IQR 15-20) underwent surgery at seven Swedish hospitals. Samples were cultured from skin, surgical wound, discs and vertebrae. Genetic relatedness of C. acnes isolates was investigated using single-nucleotide polymorphism analysis. DNA samples collected from discs/vertebrae were analysed using 16S rRNA-based PCR sequencing. MRI findings were assessed for Modic changes. RESULTS: No bacterial growth was found in 6/40 (15%) LDH patients, compared with 3/20 (15%) scoliosis patients. Most positive samples in both groups were isolated from the skin and then from subcutis or deep within the wound. Of the four disc and vertebral samples from each of the 60 patients, 235/240 (98%) were DNA negative by bacterial PCR. A single species, C. acnes, was found exclusively in the disc/vertebra from one patient in each group. In the LDH group, 29/40 (72%) patients had at least one sample with growth of C. acnes, compared to 14/20 (70%) in the scoliosis group. Bacterial findings and Modic changes were not associated. CONCLUSIONS: Cutibacterium acnes found in discs and vertebrae during surgery for disc herniation in adults with degenerated discs may be caused by contamination, as findings in this group were similar to findings in a control group of young patients with scoliosis and non-degenerated discs. Furthermore, such findings were almost always combined with bacterial findings on the skin and/or in the wound. There was no association between preoperative Modic changes and bacterial findings. Antibiotic treatment of lumbar disc herniation with sciatica and/or low back pain, without signs of clinical discitis/spondylitis, should be seriously questioned. These slides can be retrieved under Electronic Supplementary Material.

A Person-Centered Prehabilitation Program Based on Cognitive-Behavioral Physical Therapy for Patients Scheduled for Lumbar Fusion Surgery: A Randomized Controlled Trial.

BACKGROUND: Prehabilitation programs have led to improved postoperative outcomes in several surgical contexts, but there are presently no guidelines for the prehabilitation phase before lumbar fusion surgery. OBJECTIVE: The objective was to investigate whether a person-centered physical therapy prehabilitation program, based on a cognitive-behavioral approach, is more effective than conventional care in reducing disability and improving functioning after lumbar fusion surgery in patients with degenerative disk disease. DESIGN: This study was a randomized controlled trial. SETTING: The study took place at 2 private spine clinics and 1 university hospital. PATIENTS: We prospectively enrolled 118 patients scheduled for lumbar fusion surgery. INTERVENTION: The active intervention used a person-centered perspective and focused on promoting physical activity and targeting psychological risk factors before surgery. The control group received conventional preoperative care. MEASUREMENTS: The primary outcome was the Oswestry Disability Index score. Secondary outcomes were back and leg pain intensity, catastrophizing, kinesiophobia, self-efficacy, anxiety, depression, health-related quality of life, and patient-specific functioning, physical activity, and physical capacity. Data were collected on 6 occasions up to 6 months postoperatively. A linear mixed model was used to analyze the change scores of each outcome. RESULTS: No statistically significant between-group difference was found on the primary outcome (disability) over time (baseline to 6 months). Among secondary outcome measures, a statistically significant interaction effect ("Group × Time") was seen for the European Quality of Life 5 Dimensions Questionnaire. The largest between-group difference on the European Quality of Life 5 Dimensions Questionnaire index was seen 1 week prior to surgery and favored the active intervention. The largest between-group effect sizes at the 6-month follow-up favored the active intervention, and were seen for physical activity intensity, steps per day, and the One Leg Stand Test. Both groups reached the minimal important change for the primary outcome and, in several secondary outcomes (pain intensity, back and leg; pain catastrophizing; anxiety; health-related quality of life [EQ5D VAS]), already at 8-week follow-up. LIMITATIONS: The participants' preoperative level of disability was lower than normative values, which suggests selection bias. CONCLUSIONS: Both interventions led to clinically important changes, but it is not clear what kind of prehabilitation program is the most effective.

The Association Between Patient Reported Outcomes of Spinal Surgery and Societal Costs: A Register Based Study.

STUDY DESIGN: Retrospective register-based study using Swedish registers and data prospectively collected in quality register Swespine. OBJECTIVE: Analyze the association of societal costs and spine surgery outcome in low back pain (LBP) patients based on patient reported outcome measures (PROMs). SUMMARY OF BACKGROUND DATA: Studies show that LBP has a substantial impact on societal cost. There are indications that the burden diverges over different patient groups, but little is known about cost patterns in relation to PROMs of LBP surgery. METHODS: We utilized a database with data from six registers. All lumbar spine surgery patients registered in Swespine 2000 to 2012 were identified. Swespine collects PROMs Global Assessment of pain improvement (GA), Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and EuroQol five-dimension scale (EQ-5D). A literature search was conducted to identify threshold changes in ODI, VAS, and EQ-5D representing a significant improvement or deterioration as defined by the minimal clinically important difference (MCID). We categorized patients into groups by their GA response at 2-year follow-up and estimated mean changes in ODI, VAS, and EQ-5D for each group. These changes were compared with the MCID thresholds to determine a GA-anchored classification of surgical outcomes. Costs consisted of out/inpatient care, sick leave, early retirement, and pharmaceuticals. RESULTS: In total, 12,350 patients were included. GA 1-2 ("pain has disappeared"/"pain is much improved") were labeled successful surgery outcomes (67%), GA 3 ("pain somewhat improved"), undetermined (16%), and GA 4-5 ("no change in pain"/"pain has worsened") unsuccessful (17%). Costs of the unsuccessful and undetermined were higher than of the successful during the entire study period, with differences increasing markedly post-surgery. For the successful, a downward cost trend was observed; costs almost returned to the level observed 3 years pre-surgery. No such trend was observed in the other groups. CONCLUSION: Identifying patients with higher probability of responding to surgery could lead to improved health and substantial societal cost savings. LEVEL OF EVIDENCE: 3.

Lumbar spinal stenosis: comparison of surgical practice variation and clinical outcome in three national spine registries.

BACKGROUND CONTEXT: Decompression surgery for lumbar spinal stenosis (LSS) is the most common spinal procedure in the elderly. To avoid persisting low back pain, adding arthrodesis has been recommended, especially if there is a coexisting degenerative spondylolisthesis. However, this strategy remains controversial, resulting in practice-based variation. PURPOSE: The present study aimed to evaluate in a pragmatic study if surgical selection criteria and variation in use of arthrodesis in three Scandinavian countries can be linked to variation in treatment effectiveness. STUDY DESIGN: This is an observational study based on a combined cohort from the national spine registries of Norway, Sweden, and Denmark. PATIENT SAMPLE: Patients aged 50 and older operated during 2011-2013 for LSS were included. OUTCOME MEASURES: Patient-Reported Outcome Measures (PROMs): Oswestry Disability Index (ODI) (primary outcome), Numeric Rating Scale (NRS) for leg pain and back pain, and health-related quality of life (Euro-Qol-5D) were reported. Analysis included case-mix adjustment. In addition, we report differences in hospital stay. METHODS: Analyses of baseline data were done by analysis of variance (ANOVA), chi-square, or logistic regression tests. The comparisons of the mean changes of PROMs at 1-year follow-up between the countries were done by ANOVA (crude) and analysis of covariance (case-mix adjustment). RESULTS: Out of 14,223 included patients, 10,890 (77%) responded at 1-year follow-up. Apart from fewer smokers in Sweden and higher comorbidity rate in Norway, baseline characteristics were similar. The rate of additional fusion surgery (patients without or with spondylolisthesis) was 11% (4%, 47%) in Norway, 21% (9%, 56%) in Sweden, and 28% (15%, 88%) in Denmark. At 1-year follow-up, the mean improvement for ODI (95% confidence interval) was 18 (17-18) in Norway, 17 (17-18) in Sweden, and 18 (17-19) in Denmark. Patients operated with arthrodesis had prolonged hospital stay. CONCLUSIONS: Real-life data from three national spine registers showed similar indications for decompression surgery but significant differences in the use of concomitant arthrodesis in Scandinavia. Additional arthrodesis was not associated with better treatment effectiveness.

Effectiveness of surgery for sciatica with disc herniation is not substantially affected by differences in surgical incidences among three countries: results from the Danish, Swedish and Norwegian spine registries.

PURPOSE: Yearly incidence of surgery for symptomatic lumbar disc herniation varies and is 29/100,000 in Sweden, 46/100,000 in Denmark and 58/100,000 in Norway. This variation was used to study whether differences in surgical incidence were associated with differences in preoperative patient characteristics as well as patient-reported outcomes. METHODS: Data from the national spine registers in Sweden, Denmark and Norway during 2011-2013 were pooled, and 9965 individuals, aged 18-65 years, of which 6468 had one-year follow-up data, were included in the study. Both absolute and case-mix-adjusted comparisons of the primary outcome Oswestry Disability Index (ODI) and the secondary outcomes EQ-5D-3L, and Numerical Rating Scale (NRS) for leg and back pain were performed. Case-mix adjustment was done for baseline age, sex, BMI, smoking, co-morbidity, duration of leg pain and preoperative value of the dependent variable. RESULTS: Mean improvement in the outcome variables exceeded previously described minimal clinical important change in all countries. Mean (95% CI) final scores of ODI were 18 (17-18), 19 (18-20) and 15 (15-16) in Sweden, Denmark and Norway, respectively. Corresponding results of EQ-5D-3L were 0.74 (0.73-0.75), 0.73 (0.72-0.75) and 0.75 (0.74-0.76). Results of NRS leg and back pain behaved similarly. Case-mix adjustment did not alter the findings substantially. CONCLUSION: We found no clear association between incidence of surgery for lumbar disc herniation and preoperative patient characteristics as well as outcome, and the differences between the countries were lower than the minimal clinical important difference in all outcomes. These slides can be retrieved under Electronic Supplementary Material.

Prediction of Objectively Measured Physical Activity and Self-Reported Disability Following Lumbar Fusion Surgery.

OBJECTIVE: To investigate the predictive value of preoperative fear-avoidance factors (self-efficacy for exercise, pain catastrophizing, kinesiophobia, and depression), walking capacity, and traditional predictor variables for predicting postoperative changes in physical activity level and disability 6 months after lumbar fusion surgery in patients with chronic low back pain (LBP). METHODS: We prospectively enrolled 118 patients scheduled for lumbar fusion surgery for motion-elicited chronic LBP with degenerative changes in 1-3 segments of the lumbar spine. Associations between the predictors and the dependent variables were investigated with multiple linear regression analysis. Dependent variables were physical activity level as objectively measured with a triaxial accelerometer and disability as measured with the Oswestry Disability Index. RESULTS: Preoperative physical activity level (ß = -0.349; P < 0.001) and self-efficacy for exercise (ß = 0.176; P = 0.021) were significant predictors of the postoperative change in physical activity. Preoperative disability (ß = -0.790; P < 0.001), self-efficacy for exercise (ß = 0.152; P = 0.024), and pain catastrophizing (ß = 0.383; P = 0.033) were significant predictors for the change in the Oswestry Disability Index. CONCLUSIONS: Patients with low levels of preoperative physical activity were more likely to increase their level of physical activity after lumbar fusion surgery, especially when their self-efficacy for exercise was high. However, most of these patients still had low levels of physical activity after surgery, and they may therefore need extra support in increasing their postoperative physical activity levels.

Predicting clinical outcome and length of sick leave after surgery for lumbar spinal stenosis in Sweden: a multi-register evaluation.

PURPOSE: Lumbar spinal stenosis (LSS) can be surgically treated, with variable outcome. Studies have linked socioeconomic factors to outcome, but no nation-wide studies have been performed. This register-based study, including all patients surgically treated for LSS during 2008-2012 in Sweden, aimed to determine predictive factors for the outcome of surgery. METHODS: Clinical and socioeconomic factors with impact on outcome in LSS surgery were identified in several high-coverage registers, e.g., the national quality registry for spine surgery (Swespine, FU-rate 70-90%). Multivariate regression analyses were conducted to assess their effect on outcome. Two patient-reported outcome measures, Global Assessment of leg pain (GA) and the Oswestry Disability Index (ODI), as well as length of sick leave after surgery were analyzed. RESULTS: Clinical and socioeconomic factors significantly affected health outcome (both GA and ODI). Some predictors of a good outcome (ODI) were: being born in the EU, reporting no back pain at baseline, a high disposable income and a high educational level. Some factors predicting a worse outcome were previous surgery, having had back pain more than 2 years, having comorbidities, being a smoker, being on social welfare and being unemployed. CONCLUSIONS: The study highlights the relevance of adding socioeconomic factors to clinical factors for analysis of patient-reported outcomes, although the causal pathway of most predictors' impact is unknown. These findings should be further investigated in the perspective of treatment selection for individual LSS patients. The study also presents a foundation of case mix algorithms for predicting outcome of surgery for LSS. These slides can be retrieved under Electronic Supplementary Material.

Patients with severe low back pain exhibit a low level of physical activity before lumbar fusion surgery: a cross-sectional study.

BACKGROUND: People with severe low back pain are at higher risk of poor health. Patients scheduled for lumbar fusion surgery are assumed to have low levels of physical activity, but few data exist. The aim of the study was firstly to investigate preoperative levels of objectively measured physical activity in patients with severe low back pain waiting for lumbar fusion surgery, and secondly to investigate whether factors in the fear-avoidance model were associated with these levels. METHODS: We included 118 patients waiting for lumbar fusion surgery (63 women and 55 men; mean age 46 years). Physical activity expressed as steps per day and total time spent in at least moderate-intensity physical activity was assessed with ActiGraph GT3X+ accelerometers. The data were compared to the WHO recommendations on physical activity for health. Whether factors in the fear-avoidance model were associated with physical activity was evaluated by two different multiple linear regression models. RESULTS: Ninety-six patients (83%) did not reach the WHO recommendations on physical activity for health, and 19 (16%) patients took fewer than 5000 steps per day, which indicates a sedentary lifestyle. On a group level, higher scores for fear of movement and disability were associated with lower numbers of steps per day. CONCLUSION: A high proportion of the patients did not reach the WHO recommendations on physical activity and are therefore at risk of poor health due to insufficient physical activity. We also found a negative association between both fear of movement and disability, and the number of steps per day. Action needs to be taken to motivate patients to be more physically active before surgery, to improve health postoperatively. There is a need for interventions aimed at increasing physical activity levels and reducing barriers to physical activity in the prehabilitation phase of this patient group. TRIAL REGISTRATION: Current Controlled Trials ISCRTN 17115599 , retrospectively Registered 18 may 2015.

Cost of low back pain: results from a national register study in Sweden.

PURPOSE: To estimate the societal costs of low back pain with/without radiating leg pain (LBP). LBP is a major burden in terms of both personal suffering and societal costs. METHODS: Patients visiting healthcare providers with a LBP-diagnosis in the Western region of Sweden (Västra Götaland) in 2008-2011 were identified in national registers and an administrative patient database. Direct healthcare costs and indirect costs in terms of sick leave and early retirement were summarized over time periods called LBP episodes, starting with a LBP-related healthcare contact or work absence due to LBP and ended when 6 months had elapsed without any LBP-related healthcare contact or work absence. RESULTS: The mean total cost per episode was estimated at €2753 with a mean duration of 51 days. There was a sharp increase in total cost the first month after the LBP episode started and a marked decrease from the second month. Total cost leveled off at a higher level during the 2 years after episode start compared with the 2 years before episode start. The total economic burden of LBP in Sweden including all LBP episodes that started in 2011 was estimated at €740 million, or €78 per capita. CONCLUSIONS: LBP has an apparent impact on the overall resource use and work loss. The results indicate that there is a high short-term cost increase at the beginning of an LBP episode, but also that the costs decrease in the long term after the LBP symptoms have come to clinical attention. These slides can be retrieved under Electronic Supplementary Material.