Neurons in the dorsal root ganglion (DRG) receive and transmit sensory information from the tissues they innervate and from the external environment. Upper cervical (C1-C2) DRGs are functionally unique as they receive input from the neck, head and occipital cranial dura, the latter two of which are also innervated by the trigeminal ganglion (TG). The C2 DRG also plays an important role in neck pain, a common and disabling disorder that is poorly understood. Advanced transcriptomic approaches have significantly improved our ability to characterize RNA expression patterns at single-cell resolution in the DRG and TG, but no previous studies have characterized the C2 DRG. Our aim was to use single-nucleus and spatial transcriptomic approaches to create a molecular map of C2 DRGs from patients undergoing arthrodesis surgery with ganglionectomy. Patients with acute (<3 months) or chronic (≥3 months) neck pain were enrolled and completed patient-reported outcome and somatosensory measures prior to surgery. C2 DRGs were characterized with bulk, single-nucleus and spatial RNA sequencing technologies from 22 patients. Through a comparative analysis to published datasets of the lumbar DRG and TG, neuronal clusters identified in both TG and DRG were identified in the C2 DRG. Therefore, our study characterizes the molecular composition of human C2 neurons and establishes their similarity with unique characteristics of subsets of TG neurons. We identified differentially expressed genes in endothelial, fibroblast and myelinating Schwann cells associated with chronic pain, including FGFBP2, C8orf34 and EFNA1, which have been identified in previous genome- and transcriptome-wide association studies. Our work provides the first characterization of the human C2 DRG and identifies altered gene expression patterns associated with chronic neck pain. This work establishes a foundation for the exploration of painful disorders in humans affecting the cervical spine.
Pain catastrophizing is understood as a negative cognitive and emotional response to pain. Researchers, clinicians, advocates, and patients have reported stigmatizing effects of the term on patients when used clinically and in the media. This report describes the results of an international, observational, cross-sectional study investigation of clinician and researcher (professionals) perspectives on the term pain catastrophizing and whether new terminology is needed or desired. Open-ended electronic surveys were distributed to researchers and clinicians by collaborators, stakeholders, and through social media. Professionals reported on their familiarity with the term, its meaning and impacts, and their use of the term with patients. 1,397 surveys from professionals in 46 countries (48.5% from the U.S.) were received. The sample was almost two-thirds female (61.3%), with a mean age of 56.67 (SD=4.04) years, and comprised of 78.6% clinicians (63.6%, pain specialists; n=698) and 20.3% researchers. The majority were familiar with the term (82.2%; n=1148). Among the 1,098 clinicians, 33.6% had used the term in communication with patients. A content analysis of professionals’ responses to open-ended questions is presented. Coded responses were synthesized into five content categories or themes: (1) pain catastrophizing is an exaggerated response to pain; (2) pain catastrophizing is an unhelpful response to pain; (3) the term pain catastrophizing is stigmatizing; (4) the term pain catastrophizing is clinically useful; (5) patients’ perception of the term varies. Results highlight the continual controversy surrounding the term pain catastrophizing and the need for additional research and education to incorporate patient-centered approaches into clinical and public communications.Perspective:We present a content analysis of international clinician and researcher perspectives on the term pain catastrophizing. This investigation provides the largest depiction to date of the controversy surrounding pain catastrophizing and may guide future efforts to decrease stigma in patients with chronic pain and improve patient-clinician communication.
BACKGROUND CONTEXT:Recent work indicates no increased mortality risk with concurrent gabapentin and opioid use when using an active comparator control design. However, concurrent gabapentin and opioid prescriptions have been associated with greater risk of respiratory depression in some studies. PURPOSE:To compare the risk of respiratory events among Medicare enrollees with histories of spine-related diagnoses treated with gabapentin+opioids versus those treated with tricyclic antidepressants (TCA) or duloxetine+opioids. We hypothesized that enrollees treated with gabapentin+opioids would have increased risk of adverse respiratory events compared to those treated with an active control+opioids. STUDY DESIGN/SETTING:Propensity score-matched cohort study with an incident user, active comparator (TCA/duloxetine) control design. The primary analysis included those who concurrently (within 30 days) filled ≥1 incident gabapentin+≥1 opioid or ≥1 incident TCA/duloxetine+≥1 opioid prescription. PATIENT SAMPLE:US Medicare beneficiaries with histories of spine-related diagnoses 2017 to 2019. People treated with gabapentin+opioids (n=66,860) were matched on demographic and clinical factors to people treated with TCAs/duloxetine+opioids (n=66,860). OUTCOME MEASURES:Time to a composite respiratory outcome consisting of mechanical ventilation, intubation, respiratory failure, pneumonia, or acute respiratory distress syndrome. METHODS:Cox proportional hazard regression was used to estimate adjusted hazard ratios (aHRs) and 95% confidence intervals (95% CIs). RESULTS:Among 133,720 Medicare enrollees (median age 73.3 years; 66.9% female), 6277 (4.7%) experienced respiratory events before the end of follow-up. A total of 3,469 (5.2%) of people who were treated with gabapentin+opioids (median initial dose/day of gabapentin was 300 mg) had respiratory events compared to 2808 (4.2%) of those treated with an active control+opioids. The increased risk in those treated with gabapentin+opioids was statistically significant after adjustment (HR 1.19; 95% CI 1.13, 1.25; p<.0001). The most common respiratory events were pneumonia (3.7% of people in the gabapentin+opioids group versus 3.0% of people in the TCA/duloxetine+opioids group) and respiratory failure (2.3% in the gabapentin+opioids group versus 1.8% in the TCA/duloxetine+opioids group). Results were similar in analyses (a) restricted to ≤30-day follow-up and (b) that required ≥2 fills of each prescription. CONCLUSIONS:While recent work indicates no increased mortality risk with concurrent gabapentin and opioid use in this population, the current findings suggest clinicians should exercise caution in prescribing gabapentin to older adults with spine conditions who are using opioids, due to possible impacts on respiratory events. However, we cannot be certain that unmeasured confounding may explain these results and replication is needed.
Neurons in the dorsal root ganglion (DRG) receive and transmit sensory information from the tissues they innervate and from the external environment. Upper cervical (C1-C2) DRGs are functionally unique as they receive input from the neck, head, and occipital cranial dura, the latter two of which are also innervated by the trigeminal ganglion (TG). The C2 DRG also plays an important role in neck pain, a common and disabling disorder that is poorly understood. Advanced transcriptomic approaches have significantly improved our ability to characterize RNA expression patterns at single-cell resolution in the DRG and TG, but no previous studies have characterized the C2 DRG. Our aim was to use single-nucleus and spatial transcriptomic approaches to create a molecular map of C2 DRGs from patients undergoing arthrodesis surgery with ganglionectomy. Patients with acute (<3 months) or chronic (≥3 months) neck pain were enrolled and completed patient-reported outcomes and quantitative sensory testing prior to surgery. C2 DRGs were characterized with bulk, single nucleus, and spatial RNA sequencing technologies from 22 patients. Through a comparative analysis to published datasets of the lumbar DRG and TG, neuronal clusters identified in both TG and DRG were identified in the C2 DRG. Therefore, our study definitively characterizes the molecular composition of human C2 neurons and establishes their similarity with unique characteristics of subsets of TG neurons. We identified differentially expressed genes in endothelial, fibroblast and myelinating Schwann cells associated with chronic pain, including FGFBP2, C8orf34 and EFNA1 which have been identified in previous genome and transcriptome wide association studies (GWAS/TWAS). Our work establishes an atlas of the human C2 DRG and identifies altered gene expression patterns associated with chronic neck pain. This work establishes a foundation for the exploration of painful disorders in humans affecting the cervical spine.
Background:Chronic neck and low back pain are highly prevalent, leading causes of disability, and associated with long-term opioid use. The development of effective therapeutics is hampered by the limited understanding of the molecular mechanisms underlying these conditions. The Human Nociceptor and Spinal Cord Molecular Signature Center is a consortium within the NIH PRECISION Human Pain Network. The Center aims to fundamentally advance the understanding of the molecular neurobiology and neuroimmunology underlying human neck and low back pain, thereby enabling the discovery of therapeutic targets. We are pursuing this aim by applying bulk, single cell and spatial transcriptomics to tissues recovered from patients with neck and low back pain undergoing C1-2 and lumbar arthrodesis. The C2 dorsal root ganglion, facet joints, muscles, fascia, and intervertebral discs are harvested; control tissues are obtained from organ donors. A critical advantage of human research is the study of molecular neurobiological mechanisms in the context of the phenotypic complexity of chronic pain. The aim of this article is to summarize the rationale and methods used in our project to phenotype patients. Methods:Phenotyping domains include pain-related characteristics such as pain intensity, duration, and location; physical function; psychosocial function; neuropathic components assessed by self-report and quantitative sensory testing; somatosensory functions such as mechanical pain sensitivity and temporal summation; and radiological findings. Conclusion:We anticipate that comprehensive phenotyping will greatly facilitate the identification of phenotype-specific transcriptional signatures associated with chronic neck and low back pain, revealing new neurobiological and/or neuro-immunological mechanisms of painful diseases.
Very little is known about the molecular mechanisms underlying chronic neck pain, a highly prevalent and burdensome condition. We analyzed the C2 dorsal root ganglion (DRG) of patients with neck pain who underwent C1-2 arthrodesis surgery. Using spatial transcriptomics, we provide the first report of IGHG4 expression in a human DRG. IGHG4 encodes immunoglobulin G4 (IgG4). Infiltration of IgG4-producing lymphocytes characterizes IgG4-related disease, an immune-mediated inflammatory condition, and IgG4 autoantibodies sensitize DRG sensory neurons. The expression was found only in one of the 8 patients analyzed, was very high, and co-localized with B cells, which have a crucial role in IgG4 production. The findings uncover a molecular mechanism potentially involved in chronic neck pain in patients susceptible to infiltration of IgG4-producing B cells. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study was funded by: NIH: 1R01AR078192-01A1 NIH: U19NS130608 NIH: University of Washington Clinical Learning, Evidence And Research (CLEAR) Center for Musculoskeletal Research. CLEAR is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (Award Number P30AR072572). NIH R01 NS126252 Department of Defense, Peer Reviewed Medical Research Program Award Number HT9425-24-1-0109 ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the University of Washington Internal Review Board (study 10916). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors
ABSTRACT:Given the negative impact of opioid use on population health, prescriptions for alternative pain-relieving medications, including gabapentin, have increased. We wanted to determine whether people who filled gabapentin and opioid prescriptions concurrently ("gabapentin + opioids") had greater mortality than those who filled an active control medication (tricyclic antidepressants [TCAs] or duloxetine) and opioids concurrently ("TCAs/duloxetine + opioids"). In this population-based, propensity score-matched cohort study, we identified Medicare beneficiaries with spine-related diagnoses from 2017 to 2019. We compared people treated with gabapentin + opioids (n = 67,133) to people treated with TCAs/duloxetine + opioids (n = 67,133) who were matched on demographic and clinical factors. The primary outcome was mortality at any time, and a secondary outcome was occurrence of a major medical complication at any time. Among 134,266 participants (median age 73.4 years; 66.7% female), 2360 died before the end of follow-up. No difference in mortality was observed between groups (adjusted hazard ratio and 95% confidence interval for gabapentin + opioids 0.98 [0.90-1.06]; P = 0.63). However, people treated with gabapentin + opioids were at slightly increased risk of a major medical complication (1.02 [1.00-1.04]; P = 0.03) compared to those treated with TCAs/duloxetine + opioids. Results were similar in analyses (1) restricted to ≤30-day follow-up and (2) that required ≥2 fills of each prescription. When treating pain in older adults taking opioids, the addition of gabapentin did not increase mortality risk relative to addition of TCAs or duloxetine.
To comprehensively phenotype patients with acute and chronic pain from the atlanto-axial (C1-2) segment. Patients with acute (<3 months) and chronic (≥3 months) neck pain undergoing C1-2 fusion were enrolled and completed quantitative sensory testing (QST) and self-report measures of pain-related outcomes, opioid use, and psychosocial characteristics prior to surgery. Twenty patients with acute and 21 with chronic pain were enrolled. Median duration of pain (interquartile range) was 2.0 (1.0-5.5) and 365.0 days (213.0-730.0) in the acute and chronic groups, respectively. Median pain intensity (0-10 numerical rating scale) was 7.0 (4.0-9.0) and 4.5 (4.0-6.0). Twenty and 23.8% reported using opioids in the past 6 months. Median Neck Disability Index (short form, 0-24 scale) scores were 17.5 (13.0-20.0) and 12.0 (6.0-19.0). Median PHQ-2 depression (0-6) scores were 1.5 (3.0) and 2.0 (4.0), GAD-2 anxiety (0-6) scores 1.5 (0.0-2.0) and 2.0 (1.0-3.0), and PCS-4 (0-16) catastrophizing scores 9.0 (2.0-10.0) and 6.0 (3.0-12.0). QST revealed pain with brush in 1 patient, pain with light pressure in 4, pain with cold in 5, and prolonged pain after a series of 10 pinprick stimulations (reflecting pain facilitation) in 7. Our cohort was characterized by high levels of pain and disability. About one-fifth reported use of opioids. Depression, anxiety and catastrophizing were on average moderate. Neuropathic pain features as detected by QST were present in a subset of patients who may have had C2 neuropathy in addition to musculoskeletal pain and may therefore benefit from neuropathic pain treatments.
Importance: Given the negative impact of opioid use on population health, prescriptions for alternative pain-relieving medications, including gabapentin, have increased. Concurrent gabapentin and opioid prescriptions are commonly reported in retrospective studies of opioid-related overdose deaths. Objective: To determine whether people who filled gabapentin and opioid prescriptions concurrently ('gabapentin + opioids') had greater mortality than those who filled an active control medication (tricyclic antidepressants [TCAs] or duloxetine) and opioids concurrently ('TCAs/duloxetine + opioids'). We hypothesized that people treated with gabapentin + opioids would have higher mortality rates compared to people treated with TCAs/duloxetine + opioids. Design: Propensity score-matched cohort study with an incident user, active control design. The median (maximum) follow-up was 45 (1093) days. Setting: Population-based. Participants: Medicare beneficiaries with spine-related diagnoses 2017-2019. The primary analysis included those who concurrently (within 30 days) filled at least 1 incident gabapentin + at least 1 opioid or at least 1 incident TCA/duloxetine + at least 1 opioid. Exposures: People treated with gabapentin + opioids (n=67,133) were matched on demographic and clinical factors in a 1:1 ratio to people treated with TCAs/duloxetine + opioids (n=67,133). Main Outcomes and Measures: The primary outcome was mortality at any time. A secondary outcome was occurrence of a major medical complication at any time. Results: Among 134,266 participants (median age 73.4 years; 66.7% female), 2360 died before the end of follow-up. No difference in mortality was observed between groups (adjusted hazard ratio (HR) and 95% confidence interval (CI) for gabapentin + opioids was 0.98 (0.90, 1.06); p=0.63). However, people treated with gabapentin + opioids were at slightly increased risk of a major medical complication (1.02 (1.00, 1.04); p=0.03) compared to those treated with TCAs/duloxetine + opioids. Results were similar in analyses (a) restricted to less than or = 30-day follow-up and (b) that required at least 2 fills of each prescription. Conclusions and Relevance: When treating pain in older adults taking opioids, the addition of gabapentin did not increase mortality risk relative to addition of TCAs or duloxetine. However, providers should be cognizant of a small increased risk of major medical complications among opioid users initiating gabapentin compared to those initiating TCAs or duloxetine.
Conventional "1-variable-at-a-time" analyses to identify treatment effect modifiers are often underpowered and prone to false-positive results. This study used a "risk-modeling" approach guided by the Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement framework: (1) developing and validating a multivariable model to estimate predicted future back-related functional limitations as measured by the Roland-Morris Disability Questionnaire (RMDQ) and (2) stratifying patients from a randomized controlled trial (RCT) of lumbar epidural steroid injections (LESIs) for the treatment of lumbar spinal stenosis into subgroups with different individualized treatment effects on RMDQ scores at the 3-week follow-up. Model development and validation were conducted in a cohort (n = 3259) randomly split into training and testing sets in a 4:1 ratio. The model was developed in the testing set using linear regression with least absolute shrinkage and selection regularization and 5-fold cross-validation. The model was then applied in the testing set and subsequently in patients receiving the control treatment in the RCT of LESI. R2 values in the training set, testing set, and RCT were 0.38, 0.32, and 0.34, respectively. There was statistically significant modification ( P = 0.03) of the LESI treatment effect according to predicted risk quartile, with clinically relevant LESI treatment effect point estimates in the 2 quartiles with greatest predicted risk (-3.7 and -3.3 RMDQ points) and no effect in the lowest 2 quartiles. A multivariable risk-modeling approach identified subgroups of patients with lumbar spinal stenosis with a clinically relevant treatment effect of LESI on back-related functional limitations.
ABSTRACT:Because long-term opioid therapy (LtOT) for chronic pain has uncertain benefits and dose-dependent harms, safe and effective strategies for opioid tapering are needed. Adapting a promising pilot study intervention, we conducted the STRategies to Improve Pain and Enjoy life (STRIPE) pragmatic clinical trial. Patients in integrated health system on moderate-to-high dose of LtOT for chronic noncancer pain were randomized individually to usual care plus intervention (n = 79) or usual care only (n = 74). The intervention included pain coping skills training and optional support for opioid taper, delivered in 18 telephone sessions over a year, with pharmacologic guidance provided to participants' primary care providers by a pain physician. Coprimary outcomes were daily opioid dose (morphine milligram equivalent [MME]), calculated using pharmacy dispensing data, and the self-reported Pain, Enjoyment of Life and General Activity scale at 12 months (primary time point) and 6 months. Secondary outcomes included opioid misuse, opioid difficulties, opioid craving, pain self-efficacy, and global impression of change, depression, and anxiety. Only 41% randomized to the intervention completed all sessions. We did not observe significant differences between intervention and usual care for MME (adjusted mean difference: -2.3 MME; 95% confidence interval: -10.6, 5.9; P = 0.578), the Pain, Enjoyment of Life, General Activity scale (0.0 [95% confidence interval: -0.5, 0.5], P = 0.985), or most secondary outcomes. The intervention did not lower opioid dose or improve pain or functioning. Other strategies are needed to reduce opioid doses while improving pain and function for patients who have been on LtOT for years with high levels of medical, mental health, and substance use comorbidity.
Contexte : Il existe peu de recherches sur l’efficacité à long terme des injections péridurales de corticostéroïdes (IPC) chez les personnes âgées, malgré la prévalence élevée des douleurs au dos et au membre inférieur dans ce groupe d’âge. Nous avons testé les hypothèses selon lesquelles les adultes plus âgés recevant une IPC, comparés aux patients n’en recevant pas : 1) présentent avant l’IPC une douleur et une impotence fonctionnelle plus graves et une qualité de vie moindre (« critères cliniques ») ; 2) présentent une amélioration des critères cliniques après l’IPC et 3) sont améliorés grâce à un effet spécifique de l’IPC. Méthodes : Nous avons étudié prospectivement des patients de plus de 65 ans consultant en soins primaires dans trois systèmes de santé étatsuniens (registre BOLD), pour nouvel épisode de lombalgie. Les critères de jugement étaient l’intensité de la douleur du/des membre(s) inférieur(s) et lombaire, l’impotence fonctionnelle et la qualité de vie, évalués au départ et lors des suivis à 3, 6, 12 et 24 mois. Nous avons classé les participants comme suit : groupe 1, IPC dans les six mois suivant la visite de référence (n = 295) ; groupe 2, pas d’IPC dans les six mois (n = 4 809) ; groupe 3, pas d’IPC dans les six mois, appariés sur score de propension au groupe 1 (n = 483). Nous avons analysé les données au moyen d’une régression linéaire avec équations d’estimation généralisées. Résultats : L’intensité de la douleur, l’impotence fonctionnelle et la qualité de vie au départ étaient significativement plus défavorables chez les patients IPC (groupe 1) que chez ceux du groupe 2. L’amélioration entre l’initiation et le 24e mois de tous les critères était statistiquement significative dans le groupe 1. Cependant, aucune différence statistiquement significative n’a été observée entre les trajectoires des critères des groupes 1 et 3, appariés sur score de propension. Conclusions : Les personnes âgées traitées par IPC présentent une amélioration à long terme. Cependant, il est peu probable que cette amélioration soit le résultat d’un effet spécifique de l’IPC. Importance : Dans ce grand suivi prospectif de deux ans chez des sujets âgés présentant un nouvel épisode de lombalgie, la douleur lombaire et la douleur du/des membre(s) inférieur(s), l’impotence fonctionnelle et la qualité de vie ont évolué favorablement après IPC ; toutefois, l’appariement sur score de propension a montré que cette amélioration n’était probablement pas due à un effet spécifique des injections, ce qui indique que les corticostéroïdes en péridural sont peu susceptibles de procurer des bénéfices à long terme aux sujets âgés présentant un nouvel épisode de douleur lombaire et de douleur du/des membre(s) inférieur(s).
ABSTRACT:This article summarizes the many initiatives and achievements of the International Association for the Study of Pain (IASP) in pain education worldwide since 1973. These range from major events such as the World Congress on Pain that attracts thousands of attendees to the more intimate and focused Pain Schools and Pain Camps. The article describes how education has been a key focus of IASP since its inception and how IASP has responded to its members' desire for access to the latest knowledge about pain and evidence-based pain treatments. The unique contribution of IASP to the study of pain is reflected in its consistent focus on a biopsychosocial approach to pain, the promotion of interactions between basic scientists and clinicians, as well as multidisciplinary and interdisciplinary collaborations. Details of these rich offerings can be found on the IASP web site, and this article provides a guide for those seeking to access them.
Pain catastrophizing is understood as a negative cognitive and emotional response to pain. Researchers, advocates and patients have reported stigmatizing effects of the term in clinical settings and the media. We conducted an international study to investigate patient perspectives on the term pain catastrophizing. Open-ended electronic patient and caregiver proxy surveys were promoted internationally by collaborator stakeholders and through social media. 3,521 surveys were received from 47 countries (77.3% from the U.S.). The sample was mainly female (82.1%), with a mean age of 41.62 (SD 12.03) years; 95% reported ongoing pain and pain duration > 10 years (68.4%). Forty-five percent (n = 1,295) had heard of the term pain catastrophizing; 12% (n = 349) reported being described as a 'pain catastrophizer' by a clinician with associated high levels of feeling blamed, judged, and dismissed. We present qualitative thematic data analytics for responses to open-ended questions, with 32% of responses highlighting the problematic nature of the term. We present the patients' perspective on the term pain catastrophizing, its material effect on clinical experiences, and associations with negative gender stereotypes. Use of patient-centered terminology may be important for favorably shaping the social context of patients' experience of pain and pain care. Perspective: Our international patient survey found that 45% had heard of the term pain catastrophizing, about one-third spontaneously rated the term as problematic, and 12% reported the term was applied to them with most stating this was a negative experience. Clinician education on patient-centered terminology may improve care and reduce stigma. (c) 2022 The Author(s). Published by Elsevier Inc. on behalf of United States Association for the Study of Pain, Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
Both mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) are effective for chronic low back pain (CLBP), but little is known regarding who might benefit more from one than the other. Using data from a randomized trial comparing MBSR, CBT, and usual care (UC) for adults aged 20 to 70 years with CLBP (N = 297), we examined baseline characteristics that moderated treatment effects or were associated with improvement regardless of treatment. Outcomes included 8-week function (modified Roland Disability Questionnaire), pain bothersomeness (0-10 numerical rating scale), and depression (Patient Health Questionnaire-8). There were differences in the effects of CBT versus MBSR on pain based on participant gender (P = .03) and baseline depressive symptoms (P = .01), but the only statistically significant moderator after Bonferroni correction was the nonjudging dimension of mindfulness. Scores on this measure moderated the effects of CBT versus MBSR on both function (P = .001) and pain (P = .04). Pain control beliefs (P <.001) and lower anxiety (P < .001) predicted improvement regardless of treatment. Replication of these findings is needed to guide treatment decision-making for CLBP. TRIAL REGISTRATION: The trial and analysis plan were preregistered in ClinicalTrials.gov (Identifier: NCT01467843). PERSPECTIVE: Although few potential moderators and nonspecific predictors of benefits from CBT or MBSR for CLBP were statistically significant after adjustment for multiple comparisons, these findings suggest potentially fruitful directions for confirmatory research while providing reassurance that patients could reasonably expect to benefit from either treatment.
Study Design. Secondary analysis of a randomized controlled trial. Objective. To assess how baseline treatment with opioids is associated with pain and function in older adults with lumbar spinal stenosis who receive epidural injections. Summary of Background Data. Data were obtained from the Lumbar Epidural Steroid injections for Spinal Stenosis trial, a double-blind, multisite, randomized controlled trial. Methods. Baseline treatment with opioids was assessed from electronic medical record prescription pharmacy data or from health utilization records collected from patients. We calculated adjusted changes in back pain numerical rating scale, leg pain numerical rating scale, and back-related disability (Roland Morris Disability Questionnaire scores) from baseline to three weeks and to six weeks among patients treated and not treated with opioids at baseline using generalized linear regression. Results. Baseline treatment with opioids was not significantly associated with back pain intensity (adjusted difference in means at three weeks of follow-up between patients treated with opioids at baseline versus not [±95% CI, 0.1 (−0.7, 0.7)], leg pain intensity [−0.2 (−0.9, 0.4)], or back-related function [−0.8 (−2.1, 0.4)]. We found similar results at six weeks of follow-up. Conclusions. Among older adults with lumbar spinal stenosis who are receiving epidural injections, those treated with opioids at baseline had similar outcomes to those who were not.
BACKGROUND:There is limited research on the long-term effectiveness of epidural steroid injections (ESI) in older adults despite the high prevalence of back and leg pain in this age group. We tested the hypotheses that older adults undergoing ESI, compared to patients not receiving ESI: (1) have worse pain, disability and quality of life ('outcomes') pre-ESI, (2) have improved outcomes after ESI and (3) have improved outcomes due to a specific ESI effect.METHODS:We prospectively studied patients ≥65 years old presenting to primary care with new episodes of back pain in three US healthcare systems (BOLD registry). Outcomes were leg and back pain intensity, disability and quality of life, assessed at baseline and 3-, 6-, 12- and 24-month follow-ups. We categorized participants as: (1) ESI within 6 months from the index visit (n = 295); (2) no ESI within 6 months (n = 4809); (3) no ESI within 6 months, propensity-score matched to group 1 (n = 483). We analysed the data using linear regression and Generalized Estimating Equations.RESULTS:Pain intensity, disability and quality of life at baseline were significantly worse at baseline in ESI patients (group 1) than in group 2. The improvement from baseline to 24 months in all outcomes was statistically significant for group 1. However, no statistically significant differences were observed between outcome trajectories for the propensity-score matched groups 1 and 3.CONCLUSIONS:Older adults treated with ESI have long-term improvement. However, the improvement is unlikely the result of a specific ESI effect.SIGNIFICANCE:In this large, two-year, prospective study in older adults with a new episode of low back pain, back pain, leg pain, disability and quality of life improved after epidural steroid injections; however, propensity-score matching revealed that the improvement was unlikely the result of a specific effect of the injections, indicating that epidural steroids are unlikely to provide long-term benefits in older adults with new episodes of back and leg pain.
Background Modifying physician behavior to more closely align with guideline-based care can be challenging. Few effective strategies resulting in appropriate spine-related health care have been reported. The Lumbar Imaging With Reporting of Epidemiology (LIRE) intervention did not result in reductions in spine care but did in opioid prescriptions written. Objectives To estimate organizational resource needs and costs associated with implementing a pragmatic, decision support-type intervention that inserted age- and modality-matched prevalence information for common lumbar spine imaging findings, using site-based resource use data from the LIRE trial. Research design Time and cost estimation associated with implementing the LIRE intervention in a health organization. Subjects Providers and patients assessed in the LIRE trial. Measures Expected personnel costs required to implement the LIRE intervention. Results Annual salaries were converted to daily average per person costs, ranging from $400 to $2,200 per day (base case) for personnel (range: $300-$2,600). Estimated total average cost for implementing LIRE was $5,009 (range: $2,651-$12,020), including conducting pilot testing with providers. Costs associated with a small amount of time for a radiologist (6-12 hours) and imaging-ordering providers (1-8 hours each) account for approximately 75% of the estimated total cost. Conclusions The process of implementing an intervention for lumbar spine imaging reports containing age- and modality-appropriate epidemiological benchmarks for common imaging findings required radiologists, imaging-ordering providers, information technology specialists, and limited testing and monitoring. The LIRE intervention seems to be a relatively low-cost, evidence-based, complementary tool that can be easily integrated into the reporting of spine imaging.