Browsing by Subject "Low Back Pain"
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Item Open Access Adding Physical Impairment to Risk Stratification Improved Outcome Prediction in Low Back Pain.(Physical therapy, 2020-09-24) Beneciuk, Jason M; George, Steven ZOBJECTIVE:Identifying subgroups of low back pain (LBP) has the potential to improve prediction of clinical outcomes. Risk stratification is one such strategy that identifies similar characteristics indicative of a common clinical outcome trajectory. The purpose of this study was to determine if an empirically derived subgrouping approach based on physical impairment measures improves information provided from the STarT Back Tool (SBT). METHODS:At baseline in this secondary analysis of a cohort study, patients (N = 144) receiving physical therapy for LBP completed the SBT and tests (active lumbar flexion, extension, lateral bending, and passive straight-leg-raise) from a validated physical impairment index. Clinical outcomes were assessed at 4 weeks and included the Numerical Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI). Exploratory hierarchical agglomerative cluster analysis identified empirically derived subgroups based on physical impairment measures. Independent samples t testing and chi-square analysis assessed baseline subgroup differences in demographic and clinical measures. Spearman rho correlation coefficient was used to assess baseline SBT risk and impairment subgroup relationships, and a 3-way mixed-model ANOVA was used to assessed SBT risk and impairment subgroup relationships with clinical outcomes at 4 weeks. RESULTS:Two physical impairment-based subgroups emerged from cluster analysis: (1) Low-Risk Impairment (n = 119, 81.5%), characterized by greater lumbar mobility and (2) High-Risk Impairment (n = 25, 17.1%), characterized by less lumbar mobility. A weak, positive relationship was observed between baseline SBT risk and impairment subgroups (rs = .170). An impairment-by-SBT risk-by-time interaction effect was observed for ODI scores but not for NPRS scores at 4 weeks. CONCLUSIONS:Physical impairment subgroups were not redundant with SBT risk categories and could improve prediction of 4-week LBP disability outcomes. Physical impairment subgroups did not improve the prediction of 4-week pain intensity scores. IMPACT:Subgroups based on physical impairment and psychosocial risk could lead to better prediction of LBP disability outcomes and eventually allow for treatment options tailored to physical and psychosocial risk.Item Embargo Development of Imaging-Based Models for Analyzing the Spatiotemporal Function of Intervertebral Discs(2023) Coppock, James AveryLumbar intervertebral discs (IVD) play a critical role in facilitating the mobility and load-bearing functionality of the spine. Consequently, degeneration of the IVDs has been linked to the development of low back pain (LBP), a leading cause of disability in the world. While the pathomechanisms leading to the development of IVD degeneration and LBP are heterogeneous and often difficult to discern, it is believed that the changes in IVD function (i.e., mechanics, composition, tissue structure) may be closely related to the development of discogenic LBP. Specifically, because the IVD has a limited capacity to repair itself, disruptions to IVD tissue structures and biochemical composition may enable nervous tissue innervation into the IVD, potentiating the development of discogenic LBP. However, because our ability to study these changes in vivo remains limited, it remains unknown whether or not we can leverage the study of IVD function to identify risk factors associated with the development of LBP prior to their transition to a painful state. Accordingly, the overarching goal of this work is to develop non-invasive imaging techniques which may be used to perform spatiotemporal analyses of IVD kinematics and composition in vivo. Building upon prior work in our lab, Specific Aim 1 of this proposed research first seeks to develop a controlled methods to investigate the links between IVD function, composition and LBP by examining the in vivo response of IVDs to controlled dynamic loading in asymptomatic individuals. Using data generated in the prior aim, Specific Aim 2 then seeks to first develop and validate an image-segmentation method which enables precise kinematic analysis of the IVD to be carried out in an automated fashion, in vivo. Subsequently, Specific Aim 2 then seeks expand our current ability to characterize IVD function in response to dynamic activity by developing and validating a novel methodology for evaluating three-dimensional (3D) internal spatiotemporal changes in IVD kinematics using a novel deep-learning-based deformable image registration network. This dissertation is organized as a collection of original research articles which were conducted during my time as a PhD student in the Musculoskeletal Bioengineering Laboratory. The first of these (Chapter 3 - Increasing BMI Increases Lumbar Intervertebral Disc Deformation Following A Treadmill Walking Stress Test) was published in the Journal of Biomechanics (Coppock et al., 2021) in May 2021. The second of these (Chapter 4 - In vivo Intervertebral Disc Mechanical Deformation Following a Treadmill Walking “Stress Test” is Inversely Related to T1rho Relaxation Time) was published in the Osteoarthritis and Cartilage (Coppock et. al, 2022). The third, and fourth manuscripts are currently under review (Chapter 5 - Automated Segmentation and Prediction of Intervertebral Disc Morphology and Uniaxial Deformations from MRI; Chapter 6 - In Vivo Analysis of Intervertebral Disc Mechanics Using a Diffeomorphic Deep-Learning Approach. Chapter 7 - The Effects of a 6-month Weight Loss Intervention on Physical Function and Serum Biomarkers in Older Adults with and without Osteoarthritis - is published in Osteoarthritis and Cartilage, Open.
Item Open Access Differences in comorbidities on low back pain and low back related leg pain.(Pain practice : the official journal of World Institute of Pain, 2011-01) Goode, Adam; Cook, Chad; Brown, Christopher; Isaacs, Robert; Roman, Matthew; Richardson, WilliamObjective
Investigate the influence of external factors such as depression and BMI among subjects with primary severe low back pain (LBP) and low back related leg pain (LBLP).Background
The report of disability in patients with LBP may be significantly influenced by confounding and moderating variables. No similar studies have examined the influence of these factors on LBLP.Methods
This study included 1,448 consecutive subjects referred to a tertiary spine clinic. Unconditional binary logistic regression was used to determine the influence of comorbidities on the relationship between self-reported back and leg pain. A change in estimate formula was used to quantify this relationship.Results
Among those subjects with primary LBP the unadjusted odds ratio was 8.58 (95% CI 4.87, 15.10) and when adjusting for BMI, depression and smoking was 5.94 (95% CI 3.04, 11.60) resulting in a 36.7% change due to confounding by these comorbidities. Among those with primary LBLP, the unadjusted odds ratio was 4.49 (95% CI 2.78, 7.27) and when adjusting for BMI and depression was 4.60 (95% CI 2.58, 8.19) resulting in a 1.7% change due to confounding by these comorbidities.Conclusion
The disability statuses of the patients with primary LBP in this study were more significantly affected by comorbidities of BMI, depression and smoking than patients with report of LBLP. However, these comorbidities contribute little to the relationship of primary low back related leg pain and Oswestry scores ≥ 40.Item Open Access Effect of Restorative Neurostimulation on Major Drivers of Chronic Low Back Pain Economic Impact.(Neurosurgery, 2023-02) Shaffrey, Christopher; Gilligan, ChristopherBackground
High-impact chronic low back pain (CLBP) correlates with high healthcare resource utilization. Therapies that can alter impact status may provide beneficial long-term economic benefits. An implantable restorative neurostimulation system (ReActiv8, Mainstay Medical) designed to over-ride multifidus inhibition to facilitate motor control restoration, thereby resolving mechanical low back pain symptoms, has shown significant durable clinical effects in moderately and severely impacted patients.Objective
To examine changes in high-impact chronic low back pain in patients treated with restorative neurostimulation at 2 years.Methods
ReActiv8-B is a prospective, international, multicenter trial to evaluate the safety and efficacy of restorative neurostimulation in patients with intractable CLBP and no prior surgery. For this longitudinal subanalysis, patients were stratified into low-, moderate-, and high-impact CLBP categories using the US Department of Health and Human Services definition comprising pain intensity, duration, and impact on work, self-care, and daily activities.Results
Of 2-year completers (n = 146), 71% had high-impact CLBP at baseline and this proportion reduced to 10%, with 85% reporting no or low impact. This corresponds with measurements of HRQoL returning to near-population norms.Conclusion
In addition to clinically meaningful improvements in pain and function with long-term durability, the overwhelming majority of patients transitioned from a high- to a no- or low-impact CLBP state. This is typically associated with significantly lower healthcare-utilization levels. The of recovery trajectory is consistent with a restorative mechanism of action and suggests that over the long term, the improvement in these health states will be maintained.Item Open Access Effectiveness of spinal fusion versus structured rehabilitation in chronic low back pain patients with and without isthmic spondylolisthesis: a systematic review.(Spine, 2011-10) Wood, Kirkham B; Fritzell, Peter; Dettori, Joseph R; Hashimoto, Robin; Lund, Teija; Shaffrey, ChrisStudy design
Systematic review.Objective
To determine if the presence of isthmic spondylolisthesis modifies the effect of treatment (fusion vs. multidimensional supervised rehabilitation) in patients with chronic low back pain (CLBP).Summary of background data
Results of spinal surgery for CLBP are variable. It is unclear whether patients with CLBP and isthmic spondylolisthesis have more success with surgery versus a multidimensional supervised rehabilitation program when compared with those with CLBP but without spondylolisthesis.Methods
A systematic search was conducted in MEDLINE and the Cochrane Collaboration Library for articles published through January 2011. Randomized controlled trials (RCTs) were included that compared spine fusion versus multidimensional supervised rehabilitation in patients with and without isthmic spondylolisthesis. Standardized mean differences (SMDs) and risk differences were calculated for common outcomes, and then compared to determine potential heterogeneity of treatment effect. The final strength of the body of literature was expressed as "high," "moderate," or "low" confidence that the evidence reflects the true effect.Results
No studies were found that directly compared the two subgroups. Three RCTs compared fusion with supervised nonoperative care in patients with CLBP without isthmic spondylolisthesis; one RCT evaluated these treatments in patients with isthmic spondylolisthesis. There were study differences in patient characteristics, type of fusion, the nature of the rehabilitation, outcomes assessed, and length of follow-up. The SMDs for pain in favor of fusion were modest at 2 years for those without isthmic spondylolisthesis, but large in favor of fusion for those with isthmic spondylolisthesis compared with rehabilitation. Similarly, the SMDs for function in patients without isthmic spondylolisthesis compared with rehabilitation was small at 2 years, but appreciably higher in favor of fusion in patients with isthmic spondylolisthesis.Conclusion
The overall strength of evidence evaluating whether the presence of isthmic spondylolisthesis modifies the effect of fusion compared with rehabilitation patients with CLBP is "low." Fusion should be considered for patients with low back pain and isthmic spondylolisthesis who have failed nonoperative treatment.Clinical recommendations
We recommend considering fusion for patients with isthmic spondylolisthesis and lower back pain who have failed nonoperative treatment.Recommendation
Weak.Item Open Access Exercise-induced pain intensity predicted by pre-exercise fear of pain and pain sensitivity.(Clin J Pain, 2011-06) Bishop, Mark D; Horn, Maggie E; George, Steven ZOBJECTIVES: Our primary goals were to determine whether preexisting fear of pain and pain sensitivity contributed to post-exercise pain intensity. METHODS: Delayed-onset muscle pain was induced in the trunk extensors of 60 healthy volunteers using an exercise paradigm. Levels of fear of pain and experimental pain sensitivity were measured before exercise. Pain intensity in the low back was collected at 24 and 48 hours post-exercise. Participants were grouped based on pain intensity. Group membership was used as the dependent variable in separate regression models for 24 and 48 hours. Predictor variables included fear, pain sensitivity, torque lost during the exercise protocol, and demographic variables. RESULTS: The final models predicting whether a participant reported clinically meaningful pain intensity at 24 hours only included baseline fear of pain at each level of pain intensity tested. The final model at 48 hours included average baseline pain sensitivity and the loss of muscle performance during the exercise protocol for 1 level of pain intensity tested (greater than 35 mm of 100 mm). DISCUSSION: Combined, these findings suggest that the initial reports of pain after injury may be more strongly influenced by fear whereas the inflammatory process and pain sensitivity may play a larger role for later pain intensity reports.Item Open Access Global and regional burden of disease and injury in 2016 arising from occupational exposures: a systematic analysis for the Global Burden of Disease Study 2016.(Occupational and environmental medicine, 2020-03) GBD 2016 Occupational Risk Factors CollaboratorsOBJECTIVES:This study provides an overview of the influence of occupational risk factors on the global burden of disease as estimated by the occupational component of the Global Burden of Disease (GBD) 2016 study. METHODS:The GBD 2016 study estimated the burden in terms of deaths and disability-adjusted life years (DALYs) arising from the effects of occupational risk factors (carcinogens; asthmagens; particulate matter, gases and fumes (PMGF); secondhand smoke (SHS); noise; ergonomic risk factors for low back pain; risk factors for injury). A population attributable fraction (PAF) approach was used for most risk factors. RESULTS:In 2016, globally, an estimated 1.53 (95% uncertainty interval 1.39-1.68) million deaths and 76.1 (66.3-86.3) million DALYs were attributable to the included occupational risk factors, accounting for 2.8% of deaths and 3.2% of DALYs from all causes. Most deaths were attributable to PMGF, carcinogens (particularly asbestos), injury risk factors and SHS. Most DALYs were attributable to injury risk factors and ergonomic exposures. Men and persons 55 years or older were most affected. PAFs ranged from 26.8% for low back pain from ergonomic risk factors and 19.6% for hearing loss from noise to 3.4% for carcinogens. DALYs per capita were highest in Oceania, Southeast Asia and Central sub-Saharan Africa. On a per capita basis, between 1990 and 2016 there was an overall decrease of about 31% in deaths and 25% in DALYs. CONCLUSIONS:Occupational exposures continue to cause an important health burden worldwide, justifying the need for ongoing prevention and control initiatives.Item Open Access Impact of Dominant Symptom on 12-Month Patient-Reported Outcomes for Patients Undergoing Lumbar Spine Surgery.(Neurosurgery, 2020-10) Devin, Clinton J; Asher, Anthony L; Archer, Kristin R; Goyal, Anshit; Khan, Inamullah; Kerezoudis, Panagiotis; Alvi, Mohammed Ali; Pennings, Jacquelyn S; Karacay, Bernes; Shaffrey, Christopher I; Bisson, Erica F; Knightly, John J; Mummaneni, Praveen V; Foley, Kevin T; Bydon, MohamadBackground
The impact of symptom characteristics on outcomes of spine surgery remains elusive.Objective
To determine the impact of symptom location, severity, and duration on outcomes following lumbar spine surgery.Methods
We queried the Quality Outcomes Database (QOD) for patients undergoing elective lumbar spine surgery for lumbar degenerative spine disease. Multivariable regression was utilized to determine the impact of preoperative symptom characteristics (location, severity, and duration) on improvement in disability, quality of life, return to work, and patient satisfaction at 1 yr. Relative predictor importance was determined using an importance metric defined as Wald χ2 penalized by degrees of freedom.Results
A total of 22 022 subjects were analyzed. On adjusted analysis, we found patients with predominant leg pain were more likely to be satisfied (P < .0001), achieve minimum clinically important difference (MCID) in Oswestry Disability Index (ODI) (P = .002), and return to work (P = .03) at 1 yr following surgery without significant difference in Euro-QoL-5D (EQ-5D) (P = .09) [ref = predominant back pain]. Patients with equal leg and back pain were more likely to be satisfied (P < .0001), but showed no significant difference in achieving MCID (P = .22) or return to work (P = .07). Baseline numeric rating scale-leg pain and symptom duration were most important predictors of achieving MCID and change in EQ-5D. Predominant symptom was not found to be an important determinant of return to work. Worker's compensation was found to be most important determinant of satisfaction and return to work.Conclusion
Predominant symptom location is a significant determinant of functional outcomes following spine surgery. However, pain severity and duration have higher predictive importance. Return to work is more dependent on sociodemographic features as compared to symptom characteristics.Item Open Access Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial.(Pain medicine (Malden, Mass.), 2020-12) George, Steven Z; Coffman, Cynthia J; Allen, Kelli D; Lentz, Trevor A; Choate, Ashley; Goode, Adam P; Simon, Corey B; Grubber, Janet M; King, Heather; Cook, Chad E; Keefe, Francis J; Ballengee, Lindsay A; Naylor, Jennifer; Brothers, Joseph Leo; Stanwyck, Catherine; Alkon, Aviel; Hastings, Susan NBackground
Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown.Design
The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures.Summary
AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.Item Open Access Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021.(The Journal of orthopaedic and sports physical therapy, 2021-11) George, Steven Z; Fritz, Julie M; Silfies, Sheri P; Schneider, Michael J; Beneciuk, Jason M; Lentz, Trevor A; Gilliam, John R; Hendren, Stephanie; Norman, Katherine SLow back pain (LBP) remains a musculoskeletal condition with an adverse societal impact. Globally, LBP is highly prevalent and a leading cause of disability. This is an update to the 2012 Academy of Orthopaedic Physical Therapy (AOPT), formerly the Orthopaedic Section of the American Physical Therapy Association (APTA), clinical practice guideline (CPG) for LBP. The overall objective of this update was to provide recommendations on interventions delivered by physical therapists or studied in care settings that included physical therapy providers. It also focused on synthesizing new evidence, with the purpose of making recommendations for specific nonpharmacologic treatments. J Orthop Sports Phys Ther 2021;51(11):CPG1-CPG60. doi:10.2519/jospt.2021.0304.Item Open Access Investigating dynamic pain sensitivity in the context of the fear-avoidance model.(Eur J Pain, 2015-01) Gay, CW; Horn, ME; Bishop, MD; Robinson, ME; Bialosky, JEBACKGROUND: Although nearly everyone at some point in their lives experiences back pain; the amount of interference with routine activity varies significantly. The fear-avoidance (FA) model of chronic pain explains how psychological variables, such as fear, act as mediating factors influencing the relationship between clinical pain intensity and the amount of interference with daily activities. What remains less clear is how other mediating factors fit within this model. The primary objective of this report was to examine the extent to which a dynamic measure of pain sensitivity provides additional information within the context of the FA model. METHOD: To address our primary objective, classic mediation and moderated mediation analyses were conducted on baseline clinical, psychological and quantitative sensory measures obtained on 67 subjects with back pain (mean age, 31.4 ± 12.1 years; 70% female). RESULTS: There was a moderately strong relationship (r = 0.52; p < 0.01) between clinical pain intensity and interference, explaining about 27% of the variance in the outcome. Mediation analyses confirmed fear partially mediated the total effect of clinical pain intensity on interference (Δβ = 0.27; p < 0.01), and accounted for an additional 16% of the variance. In our FA model, pain sensitivity did not demonstrate additional indirect effects; however, it did moderate the strength of indirect effects of fear. CONCLUSION: This preliminary modelling suggests complex interactions exist between pain-related fear and pain sensitivity measures that further explain individual differences in behaviour.Item Open Access Lumbar intervertebral disc diurnal deformations and T2 and T1rho relaxation times vary by spinal level and disc region.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2022-03) Martin, John T; Oldweiler, Alexander B; Kosinski, Andrzej S; Spritzer, Charles E; Soher, Brian J; Erickson, Melissa M; Goode, Adam P; DeFrate, Louis EPurpose
Magnetic resonance imaging (MRI) is routinely used to evaluate spine pathology; however, standard imaging findings weakly correlate to low back pain. Abnormal disc mechanical function is implicated as a cause of back pain but is not assessed using standard clinical MRI. Our objective was to utilize our established MRI protocol for measuring disc function to quantify disc mechanical function in a healthy cohort.Methods
We recruited young, asymptomatic volunteers (6 male/6 female; age 18-30 years; BMI < 30) and used MRI to determine how diurnal deformations in disc height, volume, and perimeter were affected by spinal level, disc region, MRI biomarkers of disc health (T2, T1rho), and Pfirrmann grade.Results
Lumbar discs deformed by a mean of -6.1% (95% CI: -7.6%, -4.7%) to -8.0% (CI: -10.6%, -5.4%) in height and -5.4% (CI: -7.6%, -3.3%) to -8.5% (CI: -11.0%, -6.0%) in volume from AM to PM across spinal levels. Regional deformations were more uniform in cranial lumbar levels and concentrated posteriorly in the caudal levels, reaching a maximum of 13.1% at L5-S1 (CI:-16.1%, -10.2%). T2 and T1rho relaxation times were greatest in the nucleus and varied circumferentially within the annulus. T2 relaxation times were greatest at the most cranial spinal levels and decreased caudally. In this young healthy cohort, we identified a weak association between nucleus T2 and the diurnal change in the perimeter.Conclusions
Spinal level is a key factor in determining regional disc deformations. Interestingly, deformations were concentrated in the posterior regions of caudal discs where disc herniation is most prevalent.Item Open Access Magnitude of spinal muscle damage is not statistically associated with exercise-induced low back pain intensity.(Spine J, 2011-12) Bishop, Mark D; Horn, Maggie E; Lott, Donovan J; Arpan, Ishu; George, Steven ZBACKGROUND CONTEXT: Findings on imaging of noncontractile anatomic abnormalities and the intensity of low back pain have weak associations because of false-positive rates among asymptomatic individuals. This association might be stronger for contractile tissues. PURPOSE: The purpose of this study was to examine the relationship between location and reports of pain intensity in the low back and exercise-induced muscle damage to the lumbar paraspinal muscles. STUDY DESIGN: Nondiagnostic observational study in a laboratory setting. METHODS: Delayed onset muscle soreness was induced in the low back of healthy pain-free volunteers. Measures of pain intensity (100-mm visual analog scale [VAS]) and location (area on the pain diagram) were taken before and 48 hours after exercise. Muscle damage was quantified using mechanical pain thresholds, motor performance deficits, and transverse relaxation time (T2)-weighted magnetic resonance imaging (MRI). Changes pre- to postexercise in signal intensity on T2-weighted imaging within the erector spinae, pain intensity, pain area, mechanical pain threshold, and isometric torque were assessed using paired t tests. Bivariate correlations were conducted to assess associations among muscle damage, pain intensity, and pain drawing area. RESULTS: Twenty participants volunteered (11 women; average age, 22.3 years; average body mass index, 23.5) for study participation. Reports of pain intensity at 48 hours ranged from 0 to 59 mm on the VAS. Muscle damage was confirmed by reductions in mechanical threshold (p=.011) and motor performance (p<.001) and by changes in T2-weighted MRI (p=.007). This study was powered to find an association of at least r=0.5 to be statistically significant. Correlations of continuous variables revealed no significant correlations between pain intensity and measures of muscle damage (ranging between -0.075 and 0.151). There was a significant association between the remaining torque deficit at 48 hours and pain area. CONCLUSIONS: The results of this study indicate that there was no association between the magnitude of muscle damage in the lumbar erector spinae and reported pain intensity in the low back. In future studies, larger cohorts may report statistically significant associations, but our data suggest that there will be low magnitude potentially indicating limited clinical relevance.Item Open Access Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial.(Pain, 2019-06) Rigoard, Philippe; Basu, Surajit; Desai, Mehul; Taylor, Rod; Annemans, Lieven; Tan, Ye; Johnson, Mary Jo; Van den Abeele, Carine; North, Richard; PROMISE Study GroupDespite optimal medical management (OMM), low back pain (LBP) can be disabling, particularly after spinal surgery. Spinal cord stimulation (SCS) is effective in reducing neuropathic leg pain; however, evidence is limited for LBP. This prospective, open-label, parallel-group trial randomized (1:1) failed back surgery syndrome (FBSS) patients with predominant LBP to SCS plus OMM (SCS group) or OMM alone (OMM group) at 28 sites in Europe and the Americas. If trial stimulation was successful, a multicolumn SCS system was implanted. Outcomes were assessed at baseline (before randomization) and at 1, 3, 6, and 12 months after randomization. Patients could change treatment groups at 6 months. The primary outcome was the proportion of patients with ≥50% reduction in LBP (responder) at 6 months. Secondary outcomes included change in pain intensity, functional disability, and health-related quality of life (HRQoL). The results are posted at ClinicalTrials.gov under registration number NCT01697358. In the intent-to-treat analysis, there were more responders in the SCS group than in the OMM group (13.6%, 15/110 vs 4.6%, 5/108, difference 9% with 95% confidence interval 0.6%-17.5%, P = 0.036) at 6 months. The SCS group improved in all secondary outcomes compared with the OMM group. The OMM group only improved in HRQoL. In the SCS group, 17.6% (18/102) experienced SCS-related adverse events through 6 months, with 11.8% (12/102) requiring surgical reintervention. Adding multicolumn SCS to OMM improved pain relief, HRQoL, and function in a traditionally difficult-to-treat population of failed back surgery syndrome patients with predominant LBP. Improvements were sustained at 12 and 24 months.Item Open Access Nonoperative care to manage the sacroiliac joint.(Journal of neurosurgery. Spine, 2014-04) Shaffrey, Christopher I; Smith, Justin SItem Open Access Psychological Predictors of Outcomes with Lumbar Spinal Fusion: A Systematic Literature Review.(Physiotherapy research international : the journal for researchers and clinicians in physical therapy, 2017-04) Wilhelm, Mark; Reiman, Michael; Goode, Adam; Richardson, William; Brown, Christopher; Vaughn, Daniel; Cook, ChadPurpose
To review the predictive/risk psychological factors at baseline that are associated with a favourable (or non-favourable) outcome following lumbar spinal fusion (LSF).Methods
A computer-assisted literature search of PubMed, CINAHL complete and EMBASE for studies published between January 1, 1990 and October 1, 2014 with controlled vocabulary and key words related to LSF, degenerative lumbar spine diagnoses and appropriate terms for predictive variables. Each study was required to be a retrospective or prospective design that involved LSF (all forms). Quality assessment was conducted with the Quality In Prognosis Studies tool. A study protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO# CRD42014008728).Results
The majority of the eight accepted studies were observational, prospective cohorts (n = 6). High levels of baseline depression and lower SF-36 Mental Component Scores (MCS) lower quality of life were associated with non-favourable outcomes. Two studies were rated as high quality, five were moderate and one study had low quality.Conclusions
At present, there are a number of psychological variables that are associated with a poorer outcome with LSF. Higher levels of depression and lower scores on the SF-36 MCS are the most commonly implicated. However, based on the results of the studies using single arm designs there is not enough evidence to determine which psychological variables are influential in predicting outcomes for LSF. Copyright © 2015 John Wiley & Sons, Ltd.Item Open Access Real-World Evidence for Restorative Neurostimulation in Chronic Low Back Pain-a Consecutive Cohort Study.(World neurosurgery, 2022-09) Ardeshiri, Ardeshir; Shaffrey, Christopher; Stein, Klaus-Peter; Sandalcioglu, Ibrahim ErolBackground
Neuromuscular instability of the lumbar spine resulting from impaired motor control and degeneration of the multifidus muscle is a known root cause of refractory chronic low back pain (LBP). An implantable neurostimulation system that aims to restore multifidus motor control by stimulating the L2 medial branch of the dorsal ramus thereby relieving pain and reducing disability has demonstrated clinically significant benefits in the clinical trial setting. The 1-year results of a single-site real-world cohort study are presented.Methods
This study recruited 44 consecutive patients with refractory, predominantly nociceptive axial chronic LBP, evidence of multifidus dysfunction, and no surgical indications or history of surgical intervention for chronic LBP. Each patient was implanted with a neurostimulation device. Pain (numeric rating scale), disability (Oswestry Disability Index), and quality of life (5-level EuroQol 5-Dimension) outcomes were collected at baseline and 3, 6, and 12 months after activation.Results
Statistically significant improvements in pain, disability, and quality of life from baseline were seen at all assessment time points. At 12 months after activation, mean ± standard error of the mean numeric rating scale score was reduced from 7.6 ± 0.2 to 3.9 ± 0.4 (P < 0.001), Oswestry Disability Index score was reduced from 43.0 ± 2.8 to 25.8 ± 3.9 (P < 0.001), and 5-level EuroQol 5-Dimension index improved from 0.504 ± 0.034 to 0.755 ± 0.039 (P < 0.001). No lead migrations were observed. One patient required revision due to lead fracture.Conclusions
Restorative neurostimulation is a new treatment option for well-selected patients with refractory chronic LBP. Clinically meaningful improvements in pain, disability, and quality of life demonstrated in routine clinical practice are consistent with published results of controlled trials.Item Open Access Return to sport after open and microdiscectomy surgery versus conservative treatment for lumbar disc herniation: a systematic review with meta-analysis.(Br J Sports Med, 2016-02) Reiman, Michael P; Sylvain, Jonathan; Loudon, Janice K; Goode, AdamBACKGROUND: Lumbar disc herniation has a prevalence of up to 58% in the athletic population. Lumbar discectomy is a common surgical procedure to alleviate pain and disability in athletes. We systematically reviewed the current clinical evidence regarding athlete return to sport (RTS) following lumbar discectomy compared to conservative treatment. METHODS: A computer-assisted literature search of MEDLINE, CINAHL, Web of Science, PEDro, OVID and PubMed databases (from inception to August 2015) was utilised using keywords related to lumbar disc herniation and surgery. The design of this systematic review was developed using the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Methodological quality of individual studies was assessed using the Downs and Black scale (0-16 points). RESULTS: The search strategy revealed 14 articles. Downs and Black quality scores were generally low with no articles in this review earning a high-quality rating, only 5 articles earning a moderate quality rating and 9 of the 14 articles earning a low-quality rating. The pooled RTS for surgical intervention of all included studies was 81% (95% CI 76% to 86%) with significant heterogeneity (I(2)=63.4%, p<0.001) although pooled estimates report only 59% RTS at same level. Pooled analysis showed no difference in RTS rate between surgical (84% (95% CI 77% to 90%)) and conservative intervention (76% (95% CI 56% to 92%); p=0.33). CONCLUSIONS: Studies comparing surgical versus conservative treatment found no significant difference between groups regarding RTS. Not all athletes that RTS return at the level of participation they performed at prior to surgery. Owing to the heterogeneity and low methodological quality of included studies, rates of RTS cannot be accurately determined.Item Open Access Self-reported pain and disability outcomes from an endogenous model of muscular back pain.(BMC Musculoskelet Disord, 2011-02-02) Bishop, Mark D; Horn, Maggie E; George, Steven Z; Robinson, Michael EBACKGROUND: Our purpose was to develop an induced musculoskeletal pain model of acute low back pain and examine the relationship among pain, disability and fear in this model. METHODS: Delayed onset muscle soreness was induced in 52 healthy volunteers (23 women, 17 men; average age 22.4 years; average BMI 24.3) using fatiguing trunk extension exercise. Measures of pain intensity, unpleasantness, and location, and disability, were tracked for one week after exercise. RESULTS: Pain intensity ranged from 0 to 68 with 57.5% of participants reporting peak pain at 24 hours and 32.5% reporting this at 48 hours. The majority of participants reported pain in the low back with 33% also reporting pain in the legs. The ratio of unpleasantness to intensity indicated that the sensation was considered more unpleasant than intense. Statistical differences were noted in levels of reported disability between participants with and without leg pain. Pain intensity at 24 hours was correlated with pain unpleasantness, pain area and disability. Also, fear of pain was associated with pain intensity and unpleasantness. Disability was predicted by sex, presence of leg pain, and pain intensity; however, the largest amount of variance was explained by pain intensity (27% of a total 40%). The second model, predicting pain intensity only included fear of pain and explained less than 10% of the variance in pain intensity. CONCLUSIONS: Our results demonstrate a significant association between pain and disability in this model in young adults. However, the model is most applicable to patients with lower levels of pain and disability. Future work should include older adults to improve the external validity of this model.Item Open Access Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999).(J Pain, 2014-02) Bialosky, Joel E; George, Steven Z; Horn, Maggie E; Price, Donald D; Staud, Roland; Robinson, Michael EUNLABELLED: Spinal manipulative therapy (SMT) is effective for some individuals experiencing low back pain; however, the mechanisms are not established regarding the role of placebo. SMT is associated with changes in pain sensitivity, suggesting related altered central nervous system response or processing of afferent nociceptive input. Placebo is also associated with changes in pain sensitivity, and the efficacy of SMT for changes in pain sensitivity beyond placebo has not been adequately considered. We randomly assigned 110 participants with low back pain to receive SMT, placebo SMT, placebo SMT with the instructional set "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people," or no intervention. Participants receiving the SMT and placebo SMT received their assigned intervention 6 times over 2 weeks. Pain sensitivity was assessed prior to and immediately following the assigned intervention during the first session. Clinical outcomes were assessed at baseline and following 2 weeks of participation in the study. Immediate attenuation of suprathreshold heat response was greatest following SMT (P = .05, partial η(2) = .07). Group-dependent differences were not observed for changes in pain intensity and disability at 2 weeks. Participant satisfaction was greatest following the enhanced placebo SMT. This study was registered at www.clinicaltrials.gov under the identifier NCT01168999. PERSPECTIVE: The results of this study indicate attenuation of pain sensitivity is greater in response to SMT than the expectation of receiving an SMT. These findings suggest a potential mechanism of SMT related to lessening of central sensitization and may indicate a preclinical effect beyond the expectations of receiving SMT.