The association between cervical degenerative MRI findings and self-reported neck pain, disability and headache: a cross-sectional exploratory study.

BACKGROUND: Neck pain and headache are highly prevalent conditions and leading causes of disability worldwide. Although MRI is widely used in the management of these conditions, there is uncertainty about the clinical significance of cervical MRI findings in patients with neck pain or headache. Therefore, this study aims to investigate the association between cervical degenerative MRI findings and self-reported neck pain, neck disability, and headache. METHODS: This study was a secondary analysis of a cohort of patients with low back pain aged 18-40 years recruited from a non-surgical outpatient spine clinic. The cervical MRI and outcome measures used in this analysis were collected at a four-year follow-up (2014-2017). Self-reported outcome measures included neck pain intensity, neck disability as measured by the Neck Disability Index, and headache as measured by a single NDI item. Cervical MRI findings included disc degeneration, disc contour changes, and vertebral endplate signal changes (VESC). Multivariable logistic regression analyses, adjusted for age and sex, were used to analyse the associations between MRI findings and neck pain, neck disability, and headache. RESULTS: A total of 600 participants who underwent MRI and completed the relevant questionnaires at follow-up were included. The median age was 37 years (interquartile range 31-41) and 325 (54%) were female. Of the included participants, 181 (31%) had moderate or severe neck pain, 274 (59%) had moderate or severe neck disability, 193 (42%) reported headaches, and 211 (35%) had one or more cervical degenerative MRI findings. Cervical disc degeneration and disc contour changes were positively associated with moderate or severe neck pain with odds ratio 1.6 (95% CI 1.1-2.4) and 1.6 (1.1-2.3), respectively. VESC was associated with moderate or severe neck disability with odds ratio 3.3 (1.3-8.4). No statistically significant associations were found between the MRI findings assessed and headache. CONCLUSIONS: In this cross-sectional exploratory study, we found that cervical disc degeneration and disc contour changes were associated with neck pain, and VESC was associated with neck disability. None of the MRI findings were associated with headache. The results suggest that cervical degenerative changes may contribute to the aetiology of neck symptoms, but the associations are modest and cannot guide clinical decisions.

Beliefs about back pain and associations with clinical outcomes: a primary care cohort study.

OBJECTIVE: To investigate associations between beliefs about low back pain (LBP) at baseline and pain intensity and disability at 2-week, 13-week and 52-week follow-up. DESIGN: Observational cohort study. SETTING: Primary care private chiropractic clinics in Denmark. PARTICIPANTS: A total of 2734 adults consulting a chiropractor for a new episode of LBP, with follow-up data available from 71%, 61% and 52% of the participants at 2, 13 and 52 weeks, respectively. OUTCOME MEASURES: Beliefs about LBP were measured by the Back Belief Questionnaire (BBQ) before consulting the chiropractor. Pain (Numerical Rating Scale 0-10) and disability (the Roland-Morris Disability Questionnaire) were measured at baseline and after 2, 13 and 52 weeks. Associations were explored using longitudinal linear mixed models estimating interactions between BBQ and time, and by estimating associations between single items of BBQ and 13-week outcomes. RESULTS: More positive beliefs about LBP were weakly associated with a reduction in pain at 2 weeks (ß interaction BBQ#Time=-0.02 (95% CI -0.04 to -0.001)), at 13 weeks (-0.03 (95% CI -0.05 to -0.01)) and at 52 weeks of follow-up (-0.03 (95% CI -0.05 to -0.01); p=0.003). For disability, the association was uncertain (p=0.7). The item 'Back trouble means periods of pain for the rest of one's life' had the strongest association with both reduction in pain (-0.29, 95% CI -0.4 to -0.19, p<0.001) and disability (-2.42, 95% CI -3.52 to -1.33, p<0.001) at 13-week follow-up. CONCLUSION: Positive beliefs regarding LBP, measured by the BBQ, were associated with a reduction in pain intensity at both short-term and long-term follow-up. However, the association was weak, and the clinical relevance is therefore questionable. No clear association was demonstrated between beliefs and disability. This study did not show promise that back beliefs as measured by the BBQ were helpful for predicting or explaining the course of LBP in this setting.

Surgery rates for lumbar spinal stenosis in Denmark between 2002 and 2018: a registry-based study of 43,454 patients.

BACKGROUND AND PURPOSE: Over the last decades, many countries have shown increased surgery rates for lumbar spinal stenosis (LSS), but little information is available from Denmark. We describe the development in diagnosis and surgery of LSS in Denmark between 2002 and 2018. PATIENTS AND METHODS: We collected diagnostic ICD10-codes and surgical procedure codes from private and public hospitals in Denmark from the Danish National Patient Register. Patients diagnosed with LSS and those with surgical procedure codes for decompression surgery with or without fusion were identified. Annual surgery rates were stratified by age, sex, and type of surgery. RESULTS: During these 17 years, 132,138 patients diagnosed with LSS and 43,454 surgical procedures for LSS were identified. The number of surgical procedures increased by 144%, from 23 to 56 per 100,000 inhabitants. The proportion of patients diagnosed with LSS who received surgery was about 33%, which was almost stable over time. Decompression without fusion increased by 128% from 18 to 40 per 100,000 inhabitants and decompression with fusion increased by 199%, from 5 to 15 per 100,000. INTERPRETATION: Both the prevalence of LSS diagnoses and LSS surgery rates more than doubled in Denmark between 2002 and 2018. However, the proportion of patients diagnosed with LSS who received surgery remained stable. Decompression surgery with fusion increased at a higher rate than decompression without fusion, although recent evidence suggests no advantage of decompression plus fusion over decompression alone.

A critical appraisal of clinical practice guidelines for the treatment of lumbar spinal stenosis.

OBJECTIVE: The aim of the review was to appraise clinical practice guidelines and their recommendations for the treatment of lumbar spinal stenosis. METHODS: PubMed, Medline, CINAHL, Embase, and Cochrane Central Register of Controlled Trials were searched up until 25/01/2020 for clinical practice guidelines on the management of lumbar spinal stenosis with a systematic process to generate recommendations and were publicly available. RESULTS: Ten guidelines were included, with a total of 76 recommendations for the treatment of lumbar spinal stenosis. Only 4 of the 10 guidelines were of satisfactory methodological quality according to the AGREE II instrument. Around three-quarters of recommendations (72.4%) were presented with poor evidence, with the remaining 21 presenting (27.6%) fair evidence. No recommendation presented good evidence. Recommendations were made on four types of interventions: surgery, injections, medications, and other nonsurgical treatments, with supporting evidence similar for all four treatment types. Positive recommendations were more common for injections (12/13=92.3%) and surgery (10/15=66%) than for nonsurgical treatments (6/21=28.6%) or medications (1/27=3.75%). CONCLUSIONS: Ten guidelines on the management of lumbar spinal stenosis were identified in the systematic review, but only four were of adequate methodological quality. While the evidence underpinning the various types of interventions was similar, guidelines tended to endorse surgery and injections but not nonsurgical interventions and medicines. These results support the need for greater rigor and inclusion of steps to minimize bias in the production of guidelines.

Chiropractic conservatism among chiropractic students in Denmark: prevalence and consequences.

BACKGROUND: The chiropractic profession is split between those practicing evidence-based and those whose practice is honed by vitalism. The latter has been coined 'chiropractic conservatism'. In Denmark, the chiropractic education program is university-based in close collaboration with a medical faculty. We wanted to investigate if such conservative attitudes were present in this environment. Our objectives were to i) determine the level of chiropractic conservatism, ii) investigate if this was linked to academic year of study, iii) determine the level of clinical appropriateness, and iv) to investigate if this was affected by the level of conservatism among students in a chiropractic program, where the students are taught alongside medical students at the University of Southern Denmark (SDU). METHODS: A cross-sectional survey of 146 (response-rate 76%) 3rd to 5th year pre-graduate students and 1st year postgraduate clinical interns from the chiropractic degree course at the University of Southern Denmark was conducted during autumn of 2019. The students' levels of conservatism were dichotomized into appropriate/inappropriate, summed up, and used in a linear regression model to determine the association with academic year of study. Thereafter, the conservatism score was categorized into four groups (from low -1- to high -4-). Conservatism groups were cross-tabulated with the ability to answer appropriately on nine cases concerning i) contra-indications, ii) non-indications, and iii) indications for spinal manipulation and analyzed using logistic regression. RESULTS: Generally, the Danish chiropractic students had low conservatism scores, decreasing with increasing academic year of study. Seventy percent of the students were placed in the two lowest conservative groups. The level of conservatism (categories 1-3) was moderately (but not statistically significantly) associated with an inability to recognize non-indications to treatment. Three outliers (category 4), however, revealed a highly inappropriate handling of the clinical cases. CONCLUSIONS: Chiropractic students enrolled at a university-based course closely integrated with a medical teaching environment are not immune to chiropractic conservatism. However, the course appears to attenuate it and limit its effect on clinical decision-making compared to other educational institutions.

Prevalence of multimorbid degenerative lumbar spinal stenosis with knee and/or hip osteoarthritis: protocol for a systematic review and meta-analysis.

BACKGROUND: Lumbar spinal stenosis (LSS) and knee and hip osteoarthritis (OA) are prevalent conditions in the aging population and published literature suggests they share many symptoms and often are present at the same time in patients. However, no prevalence estimates of multimorbid LSS and knee and/or hip OA are currently available. The primary objective of this systematic review is therefore to estimate the prevalence of multimorbid LSS with knee and/or hip OA using radiological, clinical, and combined case definitions. METHODS: This systematic review protocol has been designed according to the guidelines from the Cochrane Collaboration and is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. A comprehensive search will be performed in the following databases: MEDLINE, EMBASE, CENTRAL, and CINAHL. Forward citation tracking will be performed in Web of Science. No restriction for publication date and language will be applied in the literature search, but only articles in English will be included. The search strategy will include the following domains: LSS, knee OA, and hip OA. Retrieved citations will be screened by two authors independently. Disagreements will be discussed until consensus, and a third reviewer will be consulted if consensus cannot be reached. Data extraction and assessment of risk of bias assessment will be done by two authors independently, using a standardized data extraction form and a modified risk of bias tool for prevalence studies. Meta-analysis estimating prevalence with 95% CI will be performed using a random effects model. Meta-regression analyses will be performed to investigate the impact of the following covariates: LSS clinical presentations, sample population, healthcare setting, risk of bias, and other patient characteristics on prevalence estimates for multimorbid LSS and knee and/or hip OA. DISCUSSION: The results of this review will provide the first estimates of the prevalence of multimorbid LSS and hip and knee OA based on various case definitions. The impact of covariates such as LSS clinical presentations, sample population, healthcare setting, risk of bias, and patient characteristics on prevalence estimates will also be presented. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, awaiting registration.

Cognitive Functional Therapy for People with Nonspecific Persistent Low Back Pain in a Secondary Care Setting-A Propensity Matched, Case-Control Feasibility Study.

BACKGROUND: Effective, inexpensive, and low-risk interventions are needed for patients with nonspecific persistent low back pain (NS-PLBP) who are unresponsive to primary care interventions. Cognitive functional therapy (CFT) is a multidimensional behavioral self-management approach that has demonstrated promising results in primary care and has not been tested in secondary care. OBJECTIVE: To investigate the effect of CFT and compare it with usual care for patients with NS-PLBP. DESIGN: Case-control study. SETTING: A secondary care spine center. SUBJECTS: Thirty-nine patients received a CFT intervention and were matched using propensity scoring to 185 control patients receiving usual care. METHODS: The primary outcome was Roland Morris Disability Questionnaire (0-100 scale) score. Group-level differences at six- and 12-month follow-up were estimated using mixed-effects linear regression. RESULTS: At six-month follow-up, a statistically significant and clinically relevant difference in disability favored the CFT group (-20.7, 95% confidence interval [CI] = -27.2 to -14.2, P < 0.001). Significant differences also occurred for LBP and leg pain, fear, anxiety, and catastrophizing in favor of CFT. At 12-month follow-up, the difference in disability was smaller and no longer statistically significant (-8.1, 95% CI = -17.4 to 1.2, P = 0.086). Differences in leg pain intensity and fear remained significantly in favor of CFT. Treatment satisfaction was significantly higher in the CFT group at six- (93% vs 66%) and 12-month (84% vs 52%) follow-up. CONCLUSIONS: These findings support that CFT is beneficial for patients with NS-PLBP who are unresponsive to primary care interventions. Subsequent randomized controlled trials could incorporate booster sessions, which may result in larger effects at 12-month follow-up.

Exploratory study for clinical signs of MODIC changes in patients with low-back pain in the Netherlands armed forces.

Background: Magnetic resonance imaging (MRI) is being used extensively in the search for pathoanatomical factors contributing to low back pain (LBP) such as Modic changes (MC). However, it remains unclear whether clinical findings can identify patients with MC. The purpose of this explorative study was to assess the predictive value of six clinical tests and three questionnaires commonly used with patients with low-back pain (LBP) on the presence of Modic changes (MC). Methods: A retrospective cohort study was performed using data from Dutch military personnel in the period between April 2013 and July 2016. Questionnaires included the Roland Morris Disability Questionnaire, Numeric Pain Rating Scale, and Pain Self-Efficacy Questionnaire. The clinical examination included (i) range of motion, (ii) presence of pain during flexion and extension, (iii) Prone Instability Test, and (iv) straight leg raise. Backward stepwise regression was used to estimate predictive value for the presence of MC and the type of MC. The exploration of clinical tests was performed by univariable logistic regression models. Results: Two hundred eighty-six patients were allocated for the study, and 112 cases with medical records and MRI scans were available; 60 cases with MC and 52 without MC. Age was significantly higher in the MC group. The univariate regression analysis showed a significantly increased odds ratio for pain during flexion movement (2.57 [95% confidence interval (CI): 1.08-6.08]) in the group with MC. Multivariable logistic regression of all clinical symptoms and signs showed no significant association for any of the variables. The diagnostic value of the clinical tests expressed by sensitivity, specificity, positive predictive, and negative predictive values showed, for all the combinations, a low area under the curve (AUC) score, ranging from 0.41 to 0.53. Single-test sensitivity was the highest for pain in flexion: 60% (95% CI: 48.3-70.4). Conclusion: No model to predict the presence of MC, based on clinical tests, could be demonstrated. It is therefore not likely that LBP patients with MC are very different from other LBP patients and that they form a specific subgroup. However, the study only explored a limited number of clinical findings and it is possible that larger samples allowing for more variables would conclude differently.

The association between subgroups of MRI findings identified with latent class analysis and low back pain in 40-year-old Danes.

BACKGROUND: Research into the clinical importance of spinal MRI findings in patients with low back pain (LBP) has primarily focused on single imaging findings, such as Modic changes or disc degeneration, and found only weak associations with the presence of pain. However, numerous MRI findings almost always co-exist in the lumbar spine and are often present at more than one lumbar level. It is possible that multiple MRI findings are more strongly associated with LBP than single MRI findings. Latent Class Analysis is a statistical method that has recently been tested and found useful for identifying latent classes (subgroups) of MRI findings within multivariable datasets. The purpose of this study was to investigate the association between subgroups of MRI findings and the presence of LBP in people from the general population. METHODS: To identify subgroups of lumbar MRI findings with potential clinical relevance, Latent Class Analysis was initially performed on a clinical dataset of 631 patients seeking care for LBP. Subsequently, 412 participants in a general population cohort (the 'Backs on Funen' project) were statistically allocated to those existing subgroups by Latent Class Analysis, matching their MRI findings at a segmental level. The subgroups containing MRI findings from the general population were then organised into hypothetical pathways of degeneration and the association between subgroups in the pathways and the presence of LBP was tested using exact logistic regression. RESULTS: Six subgroups were identified in the clinical dataset and the data from the general population cohort fitted the subgroups well, with a median posterior probability of 93%-100%. These six subgroups described two pathways of increasing degeneration on upper (L1-L3) and lower (L4-L5) lumbar levels. An association with LBP was found for the subgroups describing severe and multiple degenerative MRI findings at the lower lumbar levels but none of the other subgroups were associated with LBP. CONCLUSION: Although MRI findings are common in asymptomatic people and the association between single MRI findings and LBP is often weak, our results suggest that subgroups of multiple and severe lumbar MRI findings have a stronger association with LBP than those with milder degrees of degeneration.

Is the Number of Different MRI Findings More Strongly Associated With Low Back Pain Than Single MRI Findings?

STUDY DESIGN: A cross-sectional and longitudinal analysis using two different datasets. OBJECTIVE: To investigate if the number of different magnetic resonance imaging (MRI) findings present is more strongly associated with low back pain (LBP) than single MRI findings. SUMMARY OF BACKGROUND DATA: Most previous studies have investigated the associations between single MRI findings and back pain rather than investigating combinations of MRI findings. If different individuals have different pathoanatomic sources contributing to their pain, then combinations of MRI findings may be more strongly associated with LBP. METHODS: This study used data from two previous studies that investigated the association between single MRI findings and LBP. One study was a cross-sectional population cohort of 412 people of 40 years; the second was a longitudinal cohort of 76 people recently recovered from LBP who were followed for 12 months. The outcome for the cross-sectional study was presence of LBP during the last year. The outcome for the longitudinal study was days to recurrence of activity limiting LBP. In both datasets, we created an aggregate score of the number of different MRI findings present in each individual and assessed the relationship between this aggregate score and LBP. RESULTS: The risk of LBP outcome increased with increasing numbers of different MRI findings. Compared with those with no MRI findings, those with three MRI findings were at substantially greater risk of LBP in the last year (odd ratio = 14.1; 95% confidence interval, 4.32-49.47) in the cross-sectional study, or of future recurrence of LBP (hazard ratio = 12.2; 95% confidence interval 1.26-118.21) in the longitudinal study. CONCLUSION: The aggregate MRI score was more strongly associated with LBP outcomes than single MRI findings in both datasets. Further investigation of this approach is indicated. LEVEL OF EVIDENCE: 2.

Degenerative Pathways of Lumbar Motion Segments--A Comparison in Two Samples of Patients with Persistent Low Back Pain.

BACKGROUND: Magnetic resonance imaging (MRI) is used to identify spinal pathoanatomy in people with persistent low back pain. However, the clinical relevance of spinal degenerative MRI findings remains uncertain. Although multiple MRI findings are almost always present at the same time, research into the association with clinical outcomes (such as pain) has predominantly focused on individual MRI findings. This study aimed to: (i) investigate how multiple MRI lumbar spine findings cluster together within two different samples of patients with low back pain, (ii) classify these clusters into hypothetical pathways of degeneration based on scientific knowledge of disco-vertebral degeneration, and (iii) compare these clusters and degenerative pathways between samples. METHODS: We performed a secondary cross-sectional analysis on two dissimilar MRI samples collected in a hospital department: (1) data from the spinal MRI reports of 4,162 low back pain patients and (2) data from an MRI research protocol of 631 low back pain patients. Latent Class Analysis was used in both samples to cluster MRI findings from lumbar motion segments. Using content analysis, each cluster was then categorised into hypothetical pathways of degeneration. RESULTS: Six clusters of MRI findings were identified in each of the two samples. The content of the clusters in the two samples displayed some differences but had the same overall pattern of MRI findings. Although the hypothetical degenerative pathways identified in the two samples were not identical, the overall pattern of increasing degeneration within the pathways was the same. CONCLUSIONS: It was expected that different clusters could emerge from different samples, however, when organised into hypothetical pathways of degeneration, the overall pattern of increasing degeneration was similar and biologically plausible. This evidence of reproducibility suggests that Latent Class Analysis may provide a new approach to investigating the relationship between MRI findings and clinically important characteristics such as pain and activity limitation.

Do MRI findings identify patients with chronic low back pain and Modic changes who respond best to rest or exercise: a subgroup analysis of a randomised controlled trial.

BACKGROUND: No previous clinical trials have investigated MRI findings as effect modifiers for conservative treatment of low back pain. This hypothesis-setting study investigated if MRI findings modified response to rest compared with exercise in patients with chronic low back pain and Modic changes. METHODS: This study is a secondary analysis of a randomised controlled trial comparing rest with exercise. Patients were recruited from a specialised outpatient spine clinic and included in a clinical trial if they had chronic low back pain and an MRI showing Modic changes. All patients received conservative treatment while participating in the trial. Five baseline MRI findings were investigated as effect modifiers: Modic changes Type 1 (any size), large Modic changes (any type), large Modic changes Type 1, severe disc degeneration and large disc herniation. The outcome measure was change in low back pain intensity measured on a 0-10 point numerical rating scale at 14-month follow-up (n = 96). An interaction ≥ 1.0 point (0-10 scale) between treatment group and MRI findings in linear regression was considered clinically important. RESULTS: The interactions for Modic Type 1, with large Modic changes or with large Modic changes Type 1 were all potentially important in size (-0.99 (95 % CI -3.28 to 1.29), -1.49 (-3.73 to 0.75), -1.49 (-3.57 to 0.58), respectively) but the direction of the effect was the opposite to what we had hypothesized-that people with these findings would benefit more from rest than from exercise. The interactions for severe disc degeneration (0.74 (-1.40 to 2.88)) and large disc herniation (-0.92 (3.15 to 1.31)) were less than the 1.0-point threshold for clinical importance. As expected, because of the lack of statistical power, no interaction term for any of the MRI findings was statistically significant. CONCLUSIONS: Three of the five MRI predictors showed potentially important effect modification, although the direction of the effect was surprising and confidence intervals were wide so very cautious interpretation is required. Further studies with adequate power are warranted to study these and additional MRI findings as potential effect modifiers for common interventions.

A comparison of three clustering methods for finding subgroups in MRI, SMS or clinical data: SPSS TwoStep Cluster analysis, Latent Gold and SNOB.

BACKGROUND: There are various methodological approaches to identifying clinically important subgroups and one method is to identify clusters of characteristics that differentiate people in cross-sectional and/or longitudinal data using Cluster Analysis (CA) or Latent Class Analysis (LCA). There is a scarcity of head-to-head comparisons that can inform the choice of which clustering method might be suitable for particular clinical datasets and research questions. Therefore, the aim of this study was to perform a head-to-head comparison of three commonly available methods (SPSS TwoStep CA, Latent Gold LCA and SNOB LCA). METHODS: The performance of these three methods was compared: (i) quantitatively using the number of subgroups detected, the classification probability of individuals into subgroups, the reproducibility of results, and (ii) qualitatively using subjective judgments about each program's ease of use and interpretability of the presentation of results.We analysed five real datasets of varying complexity in a secondary analysis of data from other research projects. Three datasets contained only MRI findings (n = 2,060 to 20,810 vertebral disc levels), one dataset contained only pain intensity data collected for 52 weeks by text (SMS) messaging (n = 1,121 people), and the last dataset contained a range of clinical variables measured in low back pain patients (n = 543 people). Four artificial datasets (n = 1,000 each) containing subgroups of varying complexity were also analysed testing the ability of these clustering methods to detect subgroups and correctly classify individuals when subgroup membership was known. RESULTS: The results from the real clinical datasets indicated that the number of subgroups detected varied, the certainty of classifying individuals into those subgroups varied, the findings had perfect reproducibility, some programs were easier to use and the interpretability of the presentation of their findings also varied. The results from the artificial datasets indicated that all three clustering methods showed a near-perfect ability to detect known subgroups and correctly classify individuals into those subgroups. CONCLUSIONS: Our subjective judgement was that Latent Gold offered the best balance of sensitivity to subgroups, ease of use and presentation of results with these datasets but we recognise that different clustering methods may suit other types of data and clinical research questions.

Can pathoanatomical pathways of degeneration in lumbar motion segments be identified by clustering MRI findings.

BACKGROUND: Magnetic Resonance Imaging (MRI) is the gold standard for detailed visualisation of spinal pathological and degenerative processes, but the prevailing view is that such imaging findings have little or no clinical relevance for low back pain. This is because these findings appear to have little association with treatment effects in clinical populations, and mostly a weak association with the presence of pain in the general population. METHODS: This study is a secondary analysis of data from 631 patients, from an outpatient spine clinic, who had been screened for inclusion in a randomised controlled trial. The available data created a total sample pool of 3,155 vertebral motion segments. The mean age of the cohort was 42 years (SD 10.8, range 18-73) and 54% were women. RESULTS: Twelve clusters of MRI findings were identified, described and grouped into five different hypothetical pathways of degeneration that appear to have face validity. CONCLUSIONS: This study has shown that Latent Class Analysis can be used to identify clusters of MRI findings from people with LBP and that those clusters can be grouped into degenerative pathways that are biologically plausible. If these clusters of MRI findings are reproducible in other datasets of similar patients, they may form a stable platform to investigate the relationship between degenerative pathways and clinically important characteristics such as pain and activity limitation.

Is the development of Modic changes associated with clinical symptoms? A 14-month cohort study with MRI.

PURPOSE: Modic changes (MCs) have been suggested to be a diagnostic subgroup of low back pain (LBP). However, the clinical implications of MCs remain unclear. For this reason, the aims of this study were to investigate how MCs developed over a 14-month period and if changes in the size and/or the pathological type of MCs were associated with changes in clinical symptoms in a cohort of patients with persistent LBP and MCs. METHODS: Information on LBP intensity and detailed information from MRI on the presence, type and size of MCs was collected at baseline and follow-up. Changes in type (type I, II, III and mixed types) and size of MCs were quantified at both time points according to a standardised evaluation protocol. The associations between change in type, change in size and change in LBP intensity were calculated using odds ratios (ORs). RESULTS: Approximately 40% of the MCs followed the expected developmental path from type I (here type I or I/II) to type II (here type II or II/III) or type I to type I/II. In general, the bigger the size of the MC at baseline, the more likely it was that it remained unchanged in size after 14 months. Patients who had MC type I at both baseline and 14-month follow-up were less likely to experience an improvement in their LBP intensity as compared to patients who did not have type I changes at both time points (OR 7.2, CI 1.3-37). There was no association between change in size of MCs type I and change in LBP intensity. CONCLUSIONS: The presence of MCs type I at both baseline and follow-up is associated with a poor outcome in patients with persistent LBP and MCs.

Rest versus exercise as treatment for patients with low back pain and Modic changes. A randomized controlled clinical trial.

BACKGROUND: Clinical experience suggests that many patients with Modic changes have relatively severe and persistent low back pain (LBP), which typically appears to be resistant to treatment. Exercise therapy is the recommended treatment for chronic LBP, however, due to their underlying pathology, Modic changes might be a diagnostic subgroup that does not benefit from exercise. The objective of this study was to compare the current state-of-the art treatment approach (exercise and staying active) with a new approach (load reduction and daily rest) for people with Modic changes using a randomized controlled trial design. METHODS: Participants were patients from an outpatient clinic with persistent LBP and Modic changes. They were allocated using minimization to either rest therapy for 10 weeks with a recommendation to rest for two hours daily and the option of using a flexible lumbar belt or exercise therapy once a week for 10 weeks. Follow-up was at 10 weeks after recruitment and 52 weeks after intervention and the clinical outcome measures were pain, disability, general health and global assessment, supplemented by weekly information on low back problems and sick leave measured by short text message (SMS) tracking. RESULTS: In total, 100 patients were included in the study. Data on 87 patients at 10 weeks and 96 patients at one-year follow-up were available and were used in the intention-to-treat analysis. No statistically significant differences were found between the two intervention groups on any outcome. CONCLUSIONS: No differences were found between the two treatment approaches, 'rest and reduced load' and 'exercise and staying active', in patients with persistent LBP and Modic changes. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00454792.

Absence of low back pain in patients followed weekly over one year with automated text messages.

BACKGROUND: In order to define the onset of a new episode of low back pain (LBP), the definition of a "non-episode" must be clear. De Vet et al reviewed the scientific literature but found no evidence-based definitions of episodes or non-episodes of LBP. However, they suggested that pain-based episodes should be preceded and followed by a period of at least one month without LBP. As LBP is an episodic disease, it is not clear whether a sufficient number of patients with LBP will be LBP-free for at least one month ("non-episode") to justify the use of this duration in the definition of pain free episode. OBJECTIVES: Two clinical populations were followed weekly over one year making it possible 1) to determine the maximum numbers in a row of weeks without LBP, 2) to determine the prevalence of non-episodes throughout a one-year period, and 3) to find the prevalence of patients who reported to be in a non-episode of LBP at the end of the study. METHODS: Secondary data were used from two recent clinical studies, in which weekly automated text messages (SMSes) had been collected on the number of days with LBP in the preceding week for one year. Weeks with 0 days of LBP were defined as "zero-weeks" and four zero-weeks in a row were defined as a period without LBP (a"non-episode") according to de Vet et al's suggestion. The study participants, all from the secondary care sector, consisted of: study 1) patients with LBP and Magnetic Resonance Imaging-identified Modic changes and study 2) patients without obvious acute disc problems, Modic changes or other pathologies, who therefore were assumed to have non-specific LBP. Both studies were two-armed intervention studies without a significant difference in outcome between intervention groups. The number of zero-weeks was identified in each participant. Thereafter the numbers of participants who reported at least one non-episode during the study period were identified. Finally, the numbers of participants who had a non-episode at the end of the study were counted. Estimates are reported with their 95% confidence intervals. RESULTS: The numbers of participants included in the analyses were 80 and 209. Most commonly, no zero weeks were reported, by 65% (55-75) and 56% (49-63) of patients, respectively. The percentages of study participants with at least one non-episode at some time during the course of the study were 20% (11-29) and 18% (15-21. The percentages of participants who were identified as being in a non-episode at the time of the last week of the study were, 5% (95% CI: 0-10) and 4% (1-7) respectively. CONCLUSIONS: The vast majority of these secondary care sector patients had a profile of more or less constant LBP. The estimates for non-episodes during the study period and at the end of the study were very similar for participants with LBP who also had Modic changes and those with non-specific LBP. It is possible that a definition of pain-free periods is pointless in patients seeking care in the secondary care sector.

Is the presence of modic changes associated with the outcomes of different treatments? A systematic critical review.

BACKGROUND: Modic changes (MCs) have been identified as a diagnostic subgroup associated with low back pain (LBP). The aetiology of MCs is still unknown and there is no effective treatment available. If MCs constitute a specific subgroup of LBP, it seems reasonable to expect different effects from different treatments. The objective of this systematic critical literature review was therefore to investigate if there is evidence in the literature that the presence of MCs at baseline is associated with a favourable outcome depending on the treatment provided for LBP. METHODS: The databases MEDLINE and EMBASE were searched for relevant articles from 1984 to December 2010. A checklist including items related to the research questions and quality of the articles was used for data extraction and quality assessment. Of the 1650 articles found, five (six studies) were included in this review but because the studies were so heterogeneous, the results have been reported separately for each study. RESULTS: The treatments studied were: lumbar epidural steroid injections (n = 1), lumbar intradiscal steroid injections (n = 2), lumbar disc replacement (n = 1), fusion surgery (n = 1) and exercise therapy (n = 1). One of the two studies investigating treatment with intradiscal steroid injections and the study investigating fusion surgery reported that MCs were positively associated with the outcomes of pain and disability. The other study on lumbar intradiscal steroid injections and the study on lumbar epidural steroid injections reported mixed results, whereas the study on lumbar disc replacement and the study on exercise therapy reported that MCs were not associated with the outcomes of pain and disability. CONCLUSIONS: The available studies on the topic were too few and too heterogeneous to reach a definitive conclusion and it is therefore still unclear if MCs may be of clinical importance when guiding or prescribing the 'right' treatment for a patient with LBP.

Routine versus needs-based MRI in patients with prolonged low back pain: a comparison of duration of treatment, number of clinical contacts and referrals to surgery.

BACKGROUND: The routine use of radiology is normally discouraged in patients with low back pain (LBP). Magnetic Resonance Imaging (MRI) provides clinicians and patients with detailed knowledge of spinal structures and has no known physical side effects. It is possible that insight into the pathological changes in LBP patients could affect patient management. However, to our knowledge, this has never been tested. Until June 2006, all patients at our specialised out-patient public clinic were referred for MRI on the basis of clinical indications, economic constraints, and availability of MRI (the "needs-based MRI" group). As a new approach, we now refer all patients who meet certain criteria for routine up-front MRI before the clinical examination (the "routine MRI" group). OBJECTIVES: The aims of this study were to investigate if these two MRI approaches resulted in differences in: (1) duration of treatment, (2) number of contacts with clinicians, and (3) referral for surgery. DESIGN: Comparison of two retrospective clinical cohorts. METHOD: Files were retrieved from consecutive patients in both groups. Criteria for referral were: (1) LBP or leg pain of at least 3 on an 11-point Numeric Rating Scale, (2) duration of present symptoms from 2 to12 months and (3) age above 18 years. A comparison was made between the "needs-based MRI" and "routine MRI" groups on the outcomes of duration of treatment and use of resources. RESULTS: In all, 169 "needs-based MRI" and 208 "routine MRI" patient files were identified. The two groups were similar in age, sex, and severity of LBP. However, the median duration of treatment for the "needs-based MRI" group was 160 versus 115 days in the "routine MRI" group (p = 0.0001). The median number of contacts with clinicians for the "needs-based MRI" group was 4 versus 3 for the "routine MRI" group (p = 0.003). There was no difference between the two approaches in frequency of referral for back surgery (p = 0.81). When the direct clinical costs were compared, the "routine MRI" group was less costly but only by euro11. CONCLUSION: In our clinic, the management strategy of routinely performing an up-front MRI at the start of treatment did reduce the duration of treatment and number of contacts with clinicians, and did not increase the rate of referral for back surgery. Also, the direct costs were not increased.