Variability in the prevalence of depression among adults with chronic pain: UK Biobank analysis through clinical prediction models.

BACKGROUND: The prevalence of depression among people with chronic pain remains unclear due to the heterogeneity of study samples and definitions of depression. We aimed to identify sources of variation in the prevalence of depression among people with chronic pain and generate clinical prediction models to estimate the probability of depression among individuals with chronic pain. METHODS: Participants were from the UK Biobank. The primary outcome was a "lifetime" history of depression. The model's performance was evaluated using discrimination (optimism-corrected C statistic) and calibration (calibration plot). RESULTS: Analyses included 24,405 patients with chronic pain (mean age 64.1 years). Among participants with chronic widespread pain, the prevalence of having a "lifetime" history of depression was 45.7% and varied (25.0-66.7%) depending on patient characteristics. The final clinical prediction model (optimism-corrected C statistic: 0.66; good calibration on the calibration plot) included age, BMI, smoking status, physical activity, socioeconomic status, gender, history of asthma, history of heart failure, and history of peripheral artery disease. Among participants with chronic regional pain, the prevalence of having a "lifetime" history of depression was 30.2% and varied (21.4-70.6%) depending on patient characteristics. The final clinical prediction model (optimism-corrected C statistic: 0.65; good calibration on the calibration plot) included age, gender, nature of pain, smoking status, regular opioid use, history of asthma, pain location that bothers you most, and BMI. CONCLUSIONS: There was substantial variability in the prevalence of depression among patients with chronic pain. Clinically relevant factors were selected to develop prediction models. Clinicians can use these models to assess patients' treatment needs. These predictors are convenient to collect during daily practice, making it easy for busy clinicians to use them.

Low back pain-driven inpatient stays in the United States: a nationwide repeated cross-sectional analysis.

BACKGROUND: Low back pain (LBP)-driven inpatient stays are resource-intensive and costly, yet data on contemporary national trends are limited. MATERIALS AND METHODS: This study used repeated cross-sectional analyses through a nationally representative sample (US National Inpatient Sample, 2016-2019). Outcomes included the rate of LBP-driven inpatient stays; the resource utilization (the proportion of receiving surgical treatments and hospital costs) and prognosis (hospital length of stay and the proportion of nonroutine discharge) among LBP-driven inpatient stays. LBP was classified as overall, nonspecific, and specific (i.e. cancer, cauda equina syndrome, vertebral infection, vertebral compression fracture, axial spondyloarthritis, radicular pain, and spinal canal stenosis). Analyses were further stratified by age, sex, and race/ethnicity. RESULTS: 292 987 LBP-driven inpatient stays (weighted number: 1 464 690) were included, with 269 080 (91.8%) of these for specific LBP and 23 907 (8.2%) for nonspecific LBP. The rate of LBP-driven inpatient stays varied a lot across demographic groups and LBP subtypes (e.g. for overall LBP, highest for non-Hispanic White 180.4 vs. lowest for non-Hispanic Asian/Pacific Islander 42.0 per 100 000 population). Between 2016 and 2019, the rate of nonspecific LBP-driven inpatient stays significantly decreased (relative change: 46.9%); however, substantial variations were found within subcategories of specific LBP-significant increases were found for vertebral infection (relative change: 17.2%), vertebral compression fracture (relative change: 13.4%), and spinal canal stenosis (relative change: 19.9%), while a significant decrease was found for radicular pain (relative change: 12.6%). The proportion of receiving surgical treatments also varied a lot (e.g. for overall LBP, highest for non-Hispanic White 74.4% vs. lowest for non-Hispanic Asian/Pacific Islander 62.8%), and significantly decreased between 2016 and 2019 (e.g. for nonspecific LBP, relative change: 28.6%). Variations were also observed for other outcomes. CONCLUSIONS: In the US, the burden of LBP-driven inpatient stays (i.e. rates of LBP-driven inpatient stays, resource utilization, and prognosis among LBP-driven inpatient stays) is enormous. More research is needed to understand why the burden varies considerably according to the LBP subtype (i.e. nonspecific and specific LBP as well as subcategories of specific LBP) and the subpopulation concerned (i.e. stratified by age, sex, and race/ethnicity).

Trends of Low Back Pain Research in Older and Working-Age Adults from 1993 to 2023: A Bibliometric Analysis.

Although the number of publications focusing on low back pain in older adults (LBP-O) and working-age adults (LBP-W) has been growing for decades, comparative research trends in these two populations, which may help to guide future investigation, have not been rigorously explored. This analysis aimed to describe publication patterns and trends of research targeting LBP-O and LBP-W over the last three decades. Peer-reviewed LBP-O and LBP-W articles published between 1993 and 2023 were retrieved from the Web of Science, which provided the details of annual publication volume, and prominent journals/countries/institutions. The relationship between the annual publication volumes and years was analyzed by Spearman correlation analysis. The hot topics and emerging trends were analyzed by VOSviewer and CiteSpace, respectively. A total of 4217 LBP-O-related and 50,559 LBP-W-related documents were included. The annual publication volumes of LBP-O and LBP-W articles increased over the years (r=0.995 to 0.998, p<0.001). The United States had the highest number of prominent institutions publishing relevant articles. The most prolific journal for LBP-O (5.4%) and LBP-W-related (6.1%) papers is the journal "Spine". Cognitive behavioral therapy, intervertebral disc (IVD) degeneration, physiotherapy, physical activity, and walking were the recent hot topics and physical activity was an emerging trend in LBP-O, while surgery and IVD degeneration (also a hot topic) were emerging trends in LBP-W. This study highlights the paucity of LBP-O-related research in the past. The United States and the journal Spine stand out in LBP research. The research trend of physical activity in LBP-O is consistent with the recognized importance of physical activity for older adults in general, and for managing LBP-O in particular. Conversely, the emerging trends of surgery and intervertebral disc degeneration in LBP-W research highlight a focus on the biomedical model of LBP despite LBP being a biopsychosocial condition.

Text messaging intervention to support patients with chronic pain during prescription opioid tapering: protocol for a double-blind randomised controlled trial.

INTRODUCTION: Increases in pain and interference with quality of life is a common concern among people with chronic non-cancer pain (CNCP) who are tapering opioid medications. Research indicates that access to social and psychological support for pain self-management may help people to reduce their opioid dose without increasing pain and interference. This study evaluates the efficacy of a text messaging intervention designed to provide people with CNCP with social and psychological support for pain self-management while tapering long-term opioid therapy (LTOT) under the guidance of their prescriber. METHODS AND ANALYSIS: A double-blind randomised controlled trial will be conducted. Patients with CNCP (n=74) who are tapering LTOT will be enrolled from across Australia. Participants will continue with their usual care while tapering LTOT under the supervision of their prescribing physician. They will randomly receive either a psychoeducational video and supportive text messaging (two Short Message Service (SMS) per day) for 12 weeks or the video only. The primary outcome is the pain intensity and interference assessed by the Pain, Enjoyment of Life and General Activity scale. Secondary outcomes include mood, self-efficacy, pain cognitions, opioid dose reduction, withdrawal symptoms, and acceptability, feasibility, and safety of the intervention. Participants will complete questionnaires at baseline and then every 4 weeks for 12 weeks and will be interviewed at week 12. This trial will provide evidence for the efficacy of a text messaging intervention to support patients with CNCP who are tapering LTOT. If proven to be efficacious and safe, this low-cost intervention can be implemented at scale. ETHICS AND DISSEMINATION: The study protocol was reviewed and approved by the Northern Sydney Local Health District (Australia). Study results will be published in peer-reviewed journals and presented at scientific and professional meetings. TRIAL REGISTRATION NUMBER: ACTRN12622001423707.

The impact of aggregate positive lifestyle behaviors on low back pain resilience and care seeking.

BACKGROUND CONTEXT: Low back pain (LBP) is a global issue, and the high associated costs are mainly attributed to a small proportion of people with LBP who seek care. Importantly, the impact of aggregate positive lifestyle behaviors on LBP resilience and care seeking is not known. PURPOSE: This study aimed to evaluate the relationship between positive lifestyle behaviors and LBP resilience. STUDY DESIGN: This study was a prospective longitudinal cohort study. PATIENT SAMPLE: Data was collected as part of the AUstralian Twin BACK Study (AUTBACK). Participants who reported a lifetime previous history of LBP at baseline were included in this analysis (n = 340). OUTCOME MEASURES: The outcomes of interest were the number of weeks without activity limiting LBP and total number of days of healthcare usage, health practitioner care, self-management care, and medication intake. METHODS: A lifestyle behavior score was built using variables of body mass index (BMI), physical activity, smoking status, and sleep quality. Negative binomial regression analyses were used to assess the relationship between the positive lifestyle behavior score and the count outcomes of number of weeks without activity limiting LBP and number of days participants used care. RESULTS: After adjusting for covariates, no association was found between participants' positive lifestyle behavior score and their number of weeks without activity limiting LBP (IRR: 1.02, 95% CI 1.00-1.05). There was a statistically significant relationship between higher positive lifestyle behavior scores and fewer number of days of participants' total healthcare usage (IRR:0.69, 95% CI 0.56-0.84), healthcare practitioner visits (IRR:0.62, 95% CI 0.45-0.84), use of self-management strategies (IRR:0.74, 95% CI 0.60-0.91), and use of pain medication (IRR:0.55, 95% CI 0.44-0.68). CONCLUSION: People who adopt optimal lifestyle behaviors, such as engaging in adequate physical activity, achieving optimal quality sleep, maintaining an ideal BMI, and not smoking, may not experience less time suffering from activity limiting LBP, but are less likely to use healthcare and pain medication for their LBP.

The modifier effect of physical activity, body mass index, and age on the association of metformin and chronic back pain: A cross-sectional analysis of 21,899 participants from the UK Biobank.

BACKGROUND: There is growing evidence of the anti-inflammatory effect of the anti-diabetic drug metformin and its use to reduce pain. However, we currently lack studies investigating whether metformin is associated with a reduction in chronic back pain prevalence when considering physical activity levels, body mass index (BMI), and age. OBJECTIVE: To investigate whether use of metformin is associated with lower levels of reporting of chronic back pain in a large cohort with type 2 diabetes when stratified for physical activity, BMI, and age. METHODS: This is a cross-sectional study of 21,889 participants with type 2 diabetes who were drawn from the UK Biobank database. We investigated whether people using metformin reported a higher prevalence of chronic low back pain than those who did not. Type 2 diabetes, chronic back pain, and metformin were self-reported. Participants were stratified according to their physical activity level (low, moderate and high), BMI (normal, overweight, and obese), and age (40 to <50; 50 to < 60; and ≥60 years). Logistic regression models were built for each physical activity level, BMI and age category to investigate the prevalence of chronic back pain amongst those using and not using metformin. RESULTS: Participants who were using metformin and who had low levels of physical activity [OR 0.87, 95%CI 0.78 to 0.96] or who were obese [OR 0.90, 95%CI 0.86 to 0.98] or older [OR 0.85, 95%CI 0.78 to 0.93] had lower odds of reporting chronic back pain than their counterparts. CONCLUSION: The anti-diabetic drug metformin might reduce prevalence of chronic low back pain in people who are older, overweight, or less active. These findings should be confirmed in studies using a longitudinal design.

Disability burden due to musculoskeletal conditions and low back pain in Australia: findings from GBD 2019.

BACKGROUND: To report the national prevalence, years lived with disability (YLDs) and attributable risk factors for all musculoskeletal conditions and separately for low back pain (LBP), as well as compare the disability burden related to musculoskeletal with other health conditions in Australia in 2019. METHODS: Global Burden of Disease (GBD) 2019 study meta-data on all musculoskeletal conditions and LBP specifically were accessed and aggregated. Counts and age-standardised rates, for both sexes and across all ages, for prevalence, YLDs and attributable risk factors are reported. RESULTS: In 2019, musculoskeletal conditions were estimated to be the leading cause of YLDs in Australia (20.1%). There were 7,219,894.5 (95% UI: 6,847,113-7,616,567) prevalent cases of musculoskeletal conditions and 685,363 (95% UI: 487,722-921,471) YLDs due to musculoskeletal conditions. There were 2,676,192 (95% UI: 2,339,327-3,061,066) prevalent cases of LBP and 298,624 (95% UI: 209,364-402,395) YLDs due to LBP. LBP was attributed to 44% of YLDs due to musculoskeletal conditions. In 2019, 22.3% and 39.8% of YLDs due to musculoskeletal conditions and LBP, respectively, were attributed to modifiable GBD risk factors. CONCLUSIONS: The ongoing high burden due to musculoskeletal conditions impacts Australians across the life course, and in particular females and older Australians. Strategies for integrative and organisational interventions in the Australian healthcare system should support high-value care and address key modifiable risk factors for disability such as smoking, occupational ergonomic factors and obesity.

Outcome Domain and Measurement Instrument Reporting in Randomized Controlled Trials of Interventions for Lumbar Spinal Stenosis: A Systematic Review.

OBJECTIVE: To describe outcome measurement instruments and outcome domains in randomized controlled trials of any interventions for lumbar spinal stenosis (LSS). DESIGN: Systematic review. LITERATURE SEARCH: The Cochrane Central Register of Controlled Trials (CENTRAL) and PubMed were searched from inception to May 2020. STUDY SELECTION CRITERIA: Trials were eligible if patients were diagnosed with LSS, with or without neurogenic claudication. Trials were eligible if they used at least 1 outcome measurement instrument. DATA SYNTHESIS: Measurement instruments used in trials were extracted and then classified into outcome domains. We described the frequency of measurement instruments and outcome domains. RESULTS: After study screening, 29 trials were included. In total, 54 different individual outcome measurement instruments were used. The Visual Analogue Scale (59%; n = 17) and the Oswestry Disability Index (52%; n = 15) were the most frequently used outcome measurement instruments in trials; function (90%; n = 26) and pain (62%; n = 18) were the most common outcome domains. CONCLUSION: In total, 54 different measurement instruments were used in trials of interventions for LSS. This diverse range of observations contributes to outcome instrument heterogeneity between trials and impedes the analysis of data due to lack of comparability. The most common outcome domains assessed were pain and function, which will help inform a core outcome measure set for symptomatic LSS. J Orthop Sports Phys Ther 2022;52(7):446-456. Epub: 18 May 2022. doi:10.2519/jospt.2022.10879.

Age- and sex-specific effects of obesity, metabolic syndrome and its components on back pain: The English Longitudinal Study of Ageing.

OBJECTIVES: We aimed to investigate age- and sex-specific effects of obesity, metabolic syndrome (MetS) and its components on back pain in middle-aged and older English individuals. METHODS: We used data from the English Longitudinal Study of Ageing, wave 2 (2004-2005). Body mass index (BMI) expressed the obesity, while MetS was defined according to revised Adult Treatment Panel (ATP) III criteria. We assessed associations between obesity, MetS and its components with presence and severity of back pain and provided estimates per strata, middle-aged (50-64years) and older (65-79years), women and men. RESULTS: The study sample included 3328 participants, 1021 and 835 middle-aged women and men and 773 and 699 older women and men, respectively. We found that BMI (OR=1.07, 95% CI 1.05-1.09), MetS (OR=1.47, 95% CI 1.22-1.77), high waist circumference (WC), high triglycerides (TG), and high fasting blood glucose were associated with the presence of back pain. Effects of BMI were consistent across the strata. However, MetS was associated with back pain only in women, middle-aged (OR=1.59, 95% CI 1.14-2.21) and older (OR=1.43, 95% CI 1.01-2.05). The MetS component driving this association was high WC, supported by high TG in older women. Higher BMI, presence of MetS, high blood pressure and TG were associated with back pain severity. CONCLUSIONS: We found that obesity was associated with the presence and severity of back pain, irrespective of age and sex. However, we found women-specific effects of MetS driven by high WC, indicating that metabolic dysregulation contributes to back pain pathophysiology in women.

Effects of body weight and fat mass on back pain - direct mechanical or indirect through inflammatory and metabolic parameters?

BACKGROUND: While reports indicate the association between obesity and back pain, its mechanism is still unclear. Thus, we aimed to investigate the effects of weight and its components on back pain in middle-aged women while considering direct mechanical and indirect effects via inflammatory and metabolic parameters. METHODS: We used data from the Chingford 1000 Women Study, two follow-ups seven years apart. We assessed effects of weight, body mass index (BMI), total fat mass (TFM), total lean mass (TLM) and total bone mineral density (TBMD), measured by dual-energy X-ray absorptiometry, on back pain episode. We used inflammatory (C-reactive protein, interleukin-6, and tumour necrosis factor-alpha) and metabolic parameters (systolic and diastolic blood pressure, triglyceride, high-density lipoprotein cholesterol, and fasting blood glucose) as mediators of indirect effects. We investigated associations of interest cross-sectionally and longitudinally using binary logistic regression and parallel mediation model. RESULTS: We included 826 Chingford middle-aged women (mean age=60.7, SD=5.9) from the first used follow-up in cross-sectional and mediation analyses and 645 women that attended the follow-up seven years later, in longitudinal analyses. We found that increased weight was directly associated with increased odds of having back pain episode (OR=1.02; 95% CI 1.01-1.03), similarly as BMI (OR=1.05; 95% CI 1.02-1.08) and TFM (OR=1.03; 95% CI 1.01-1.04) consistently across the cross-sectional and longitudinal models, but not TLM or TBMD. However, we did not find consistent indirect effects of weight or its components through measured inflammatory or metabolic parameters on back pain. CONCLUSIONS: Our results show that in middle-aged women, weight, BMI and TFM are directly related to back pain, indicating prominence of mechanical loading effect.

Evaluation of placebo fidelity and trial design methodology in placebo-controlled surgical trials of musculoskeletal conditions: a systematic review.

ABSTRACT: The number of placebo surgical trials on musculoskeletal conditions is increasing, but little is known about the quality of their design and methods. This review aimed to (1) assess the level of placebo fidelity (ie, degree to which the placebo control mimicked the index procedure) in placebo trials of musculoskeletal surgery, (2) describe the trials' methodological features using the adapted Applying Surgical Placebo in Randomised Evaluations (ASPIRE) checklist, and (3) describe each trial's characteristics. We searched 4 electronic databases from inception until February 18, 2021, for randomised trials of surgery that included a placebo control for any musculoskeletal condition. Protocols and full text were used to assess placebo fidelity (categorised as minimal, low, or high fidelity). The adapted 26-item ASPIRE checklist was also completed on each trial. PROSPERO registration number: CRD42021202131. A total of 30,697 studies were identified in the search, and 22 placebo-controlled surgical trials of 2045 patients included. Thirteen trials (59%) included a high-fidelity placebo control, 7 (32%) used low fidelity, and 2 (9%) minimal fidelity. According to the ASPIRE checklist, included trials had good reporting of the "rationale and ethics" (68% overall) and "design" sections (42%), but few provided enough information on the "conduct" (13%) and "interpretation and translation" (11%) of the placebo trials. Most trials sufficiently reported their rationale and ethics, but interpretation and translation are areas for improvement, including greater stakeholder involvement. Most trials used a high-fidelity placebo procedure suggesting an emphasis on blinding and controlling for nonspecific effects.

Association of chronic musculoskeletal pain with mortality among UK adults: A population-based cohort study with mediation analysis.

BACKGROUND: We aimed to quantify the association between chronic musculoskeletal pain and all-cause mortality, and to investigate the extent to which this association is mediated by physical activity, smoking status, alcohol consumption, and opioid use. METHODS: For this population-based cohort study, we used data from UK Biobank, UK between baseline visit (2006-2010) to 18th December 2020. We assessed the associations between chronic musculoskeletal pain and all-cause mortality using a Cox proportional hazards model. We performed causal mediation analyses to examine the proportion of the association between chronic musculoskeletal pain and all-cause mortality. FINDINGS: Of the 384,367 included participants, a total of 187,269 participants reported chronic musculoskeletal pain. Higher number of pain sites was associated with increased risk of all-cause mortality compared to having no pain (e.g., four sites vs no site of pain, Hazard Ratio [HR] 1.46, 95% Confidence Interval [CI] 1.35 to 1.57). The multiple mediator analyses showed that the mediating proportions of all four mediators ranged from 53.4% to 122.6%: among participants with two or more pain sites, the effect estimate reduced substantially, for example, HR reduced from 1.25 (95% CI: 1.21 to 1.30; two pain sites) to 1.07 (95% CI: 1.01 to 1.11; two pain sites). INTERPRETATION: We found that higher number of pain sites was associated with increased risk of all-cause mortality compared to having no pain, and at least half of the association of chronic musculoskeletal pain with increased all-cause mortality may be accounted for by four mediators. FUNDING: Twins Research Australia.

Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.

BACKGROUND: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. OBJECTIVES: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. DESIGN: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. SETTING: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. RESULTS: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. CONCLUSIONS: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. LIMITATIONS: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. FUTURE WORK: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. FUNDING: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.

WHAT WAS THE RESEARCH ABOUT?: One of the best ways to prove that a new medicine really works is to use a scientific test called a 'placebo-controlled trial'. In this type of test, half of the participants are given a new pill and the other half are given a 'placebo', which is a dummy pill (usually a sugar pill) that is made to taste and look the same as the active pill, but has no active ingredients. The results are then compared. Just like medicines, new surgical procedures need to be tested to show that they are safe and benefit patients. Ideally, they would also be tested using the 'placebo-controlled trial' approach, but asking patients to have 'dummy' surgery is not the same as asking people to take a dummy pill. Placebo surgery raises lots of ethics questions and is controversial. As it is controversial, guidelines are needed to recommend when placebo surgery studies can be used (if at all) and what special considerations need to be taken into account. Our research team was commissioned to develop these guidelines. WHAT DID WE DO?: We summarised, to the best of our knowledge, all previous research that had used placebo surgery and reviewed all the ethics literature on this topic. We also looked at the latest scientific understanding of how placebos work. We then held a workshop to discuss and summarise the existing knowledge and to develop the new guidelines. This involved an international team of patients, surgeons, researchers, ethicists, psychologists, physiologists and funders. We published the guidelines [i.e. the ASPIRE (Applying Surgical Placebo in Randomised Evaluations) guidelines] in an influential medical journal and also wrote several other publications. This report provides a slightly more detailed version of our findings and recommendations. WHO WILL THIS HELP?: The guidelines will help researchers and doctors know when, and how, to best design placebo surgery studies in the future.

How much change in symptoms do spinal surgeons expect following lumbar decompression and microdiscectomy?

The study aimed to determine how much change in neurogenic claudication spinal surgeons expect in patients following lumbar decompression for lumbar spine stenosis (LSS), and radicular leg pain following microdiscectomy. Secondary aims were to identify surgeons' preferences regarding surgical techniques for lumbar decompression, and their rating of the quality of current evidence for lumbar decompression. All Australian spine surgeons were invited, of whom 71 completed the survey (31% response rate). Only registered spinal surgeons were included. The online survey, administered using REDCap, included 4 sections: demographics and background; expected change in symptoms on a +/- 100% scale (-100% worst, 0% no change and 100% best possible); surgical preference; and rating of current evidence for lumbar decompression compared with other treatments. There were 71 complete responses, 76% were neurosurgeons (N = 54), predominantly male (96%; N = 68). On average, surgeons expected an 86% (median: 87%, inter-quartile range (IQR): 80%, 91%) improvement in neurogenic claudication following lumbar decompression for LSS and 89% (median: 91%, IQR: 85%, 95%) improvement in radicular pain following microdiscectomy. A multiple linear regression found no surgeon characteristics were associated with expected change following surgery. The preferred surgical technique for LSS was full laminectomy (58%; N = 41). Thirty-five percent of surgeons accurately rated the evidence supporting the superiority of lumbar decompression compared with non-surgical care for LSS as low quality. Spine surgeons expect large symptom improvements following lumbar decompression and microdiscectomy. Understanding of the current evidence was higher for lumbar decompression with fusion, than for decompression alone for LSS.

Association of Lumbar Spine Radiographic Changes With Severity of Back Pain-Related Disability Among Middle-aged, Community-Dwelling Women.

Importance: Previous studies, using mostly cross-sectional data, provide conflicting evidence of an association between lumbar spine radiographic changes and the severity of back pain-related disability. Such conflicting evidence may be associated with widely unnecessary diagnostic imaging of the lumbar spine. Objective: To examine both cross-sectional and longitudinal associations between lumbar spine radiographic changes and the severity of back pain-related disability among middle-aged, community-dwelling women. Design, Setting, and Participants: This population-based prospective cohort study used data from the Chingford 1000 Women Study. Analyses included data collected from year 6 (1994-1996; physical activity was measured), year 9 (1997-1999; treated as baseline), and year 15 (2003-2005), with a total length of follow-up for longitudinal analyses of 6 years. Data were analyzed from April 17 to November 3, 2020. Exposures: Primary exposure was lumbar spine radiographic changes, defined using the Kellgren-Lawrence (K-L) grade. Secondary exposures were defined using presence of osteophytes and disc space narrowing. The composite score combined the number of lumbar spine segments with definite changes detected on radiographic images (ie, radiographic changes) (K-L grade ≥2, which means at least definite osteophyte and possible narrowing of disc space are present; osteophyte and disc space narrowing grade ≥1, which means at least mild or definite changes are present). Main Outcomes and Measures: Self-reported back pain-related disability measured in years 9 and 15 assessed by the St Thomas disability questionnaire. Results: Among 650 women (mean [SD] age, 61.3 [5.9] years) in cross-sectional analyses and 443 women (mean [SD] age, 60.6 [6.0] years) in longitudinal analyses, there was no evidence to support an association between higher number of lumbar segments with radiographic changes (K-L grade, osteophytes, and disc space narrowing) and more severe back pain-related disability (eg, cross-sectional analyses using the K-L grade; 1 segment vs 0 segment: adjusted odds ratio, 1.22 [95% CI, 0.76-1.96]). No interactions were found of an association between lumbar spine radiographic changes and the severity of back pain-specific disability with age, body mass index, or smoking status. Conclusions and Relevance: In this cohort of middle-aged, community-dwelling women, there was no evidence to support an association between a higher number of lumbar segments with radiographic changes (K-L grade, osteophytes, and disc space narrowing) and more severe back pain-related disability cross-sectionally or over time. These findings provide further evidence against routinely using diagnostic imaging of the lumbar spine.

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.

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.

Barriers to participation in a placebo-surgical trial for lumbar spinal stenosis.

BACKGROUND: Placebo-controlled trials are an important tool when assessing the efficacy of spinal surgical procedures. The most common spinal surgical procedure in older adults is decompression for lumbar spinal stenosis. Before conducting a placebo-surgical trial on decompression surgery, an investigation of patients' willingness to participate in a placebo-controlled trial of decompression surgery and barriers to participation were explored. MATERIALS: An online survey. METHODS: Descriptive analyses of demographic and clinical data, and participants' willingness to participate in a placebo-surgical trial. Logistic regression was used to examine potential predictors of willingness to participate. Two independent researchers performed a coded framework analysis of patients' barriers to participation. RESULTS: 68 patients were invited and 63 participants completed the survey (91.3% response, mean (SD) age 69.5 (10.9) years, 52% females), 71% suffered from moderate to very severe pain. Ten participants (15.9%) were willing to participate in a placebo-controlled trial. Being married was associated with decreased odds of participating (OR: 0.2; 95% CI, 0.05 to 0.8; P = 0.03), while the main barriers were a lack of information about the procedure, reassurance of a positive outcome with participation, and concerns about the risks and benefits of placebo surgery. CONCLUSIONS: A minority of patients with lumbar spinal stenosis were willing to participate in a placebo-controlled trial of surgery. The identified barriers indicate that educating eligible patients about: the need for placebo-surgical trials, the personal risks and benefits of participation, and the importance and potential benefits of placebo trials to others, may be crucial to ensure adequate recruitment into the placebo-controlled surgical trial. Conclusions should be read cautiously however, given the small sample size present in this study.

SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomised, placebo-controlled trial.

INTRODUCTION: Central lumbar spinal stenosis (LSS) is a common cause of pain, reduced function and quality of life in older adults. Current management of LSS includes surgery to decompress the spinal canal and alleviate symptoms. However, evidence supporting surgical decompression derives from unblinded randomised trials with high cross-over rates or cohort studies showing modest benefits. This protocol describes the design of the SUrgery for Spinal Stenosis (SUcceSS) trial -the first randomised placebo-controlled trial of decompressive surgery for symptomatic LSS. METHODS AND ANALYSIS: SUcceSS will be a prospectively registered, randomised placebo-controlled trial of decompressive spinal surgery. 160 eligible participants (80 participants/group) with symptomatic LSS will be randomised to either surgical spinal decompression or placebo surgical intervention. The placebo surgical intervention is identical to surgical decompression in all other ways with the exception of the removal of any bone or ligament. All participants and assessors will be blinded to treatment allocation. Outcomes will be assessed at baseline and at 3, 6, 12 and 24 months. The coprimary outcomes will be function measured with the Oswestry Disability Index and the proportion of participants who have meaningfully improved their walking capacity at 3 months postrandomisation. Secondary outcomes include back pain intensity, lower limb pain intensity, disability, quality of life, anxiety and depression, neurogenic claudication score, perceived recovery, treatment satisfaction, adverse events, reoperation rate and rehospitalisation rate. Those who decline to be randomised will be invited to participate in a parallel observational cohort. Data analysis will be blinded and by intention to treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life year gained. ETHICS AND DISSEMINATION: Ethics approval has been granted by the NSW Health (reference:17/247/POWH/601) and the Monash University (reference: 12371) Human Research Ethics Committees. Dissemination of results will be via journal articles and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12617000884303; Pre-results.