Temporal Trends and Geographic Variations in the Supply of Clinicians Who Provide Spinal Manipulation to Medicare Beneficiaries: A Serial Cross-Sectional Study.

OBJECTIVE: Spinal manipulation (SM) is recommended for first-line treatment of patients with low back pain. Inadequate access to SM may result in inequitable spine care for older US adults, but the supply of clinicians who provide SM under Medicare is uncertain. The purpose of this study was to measure temporal trends and geographic variations in the supply of clinicians who provide SM to Medicare beneficiaries. METHODS: Medicare is a US government-administered health insurance program that provides coverage primarily for older adults and people with disabilities. We used a serial cross-sectional design to examine Medicare administrative data from 2007 to 2015 for SM services identified by procedure code. We identified unique providers by National Provider Identifier and distinguished between chiropractors and other specialties by Physician Specialty Code. We calculated supply as the number of providers per 100 000 beneficiaries, stratified by geographic location and year. RESULTS: Of all clinicians who provide SM to Medicare beneficiaries, 97% to 98% are doctors of chiropractic. The geographic supply of doctors of chiropractic providing SM services in 2015 ranged from 20/100 000 in the District of Columbia to 260/100 000 in North Dakota. The supply of other specialists performing the same services ranged from fewer than 1/100 000 in 11 states to 8/100 000 in Colorado. Nationally, the number of Medicare-active chiropractors declined from 47 102 in 2007 to 45 543 in 2015. The count of other clinicians providing SM rose from 700 in 2007 to 1441 in 2015. CONCLUSION: Chiropractors constitute the vast majority of clinicians who bill for SM services to Medicare beneficiaries. The supply of Medicare-active SM providers varies widely by state. The overall supply of SM providers under Medicare is declining, while the supply of nonchiropractors who provide SM is growing.

The frequency of neuropathic pain in Turkish patients with low back pain: a cross-sectional study.

The aim of this study was to evaluate the frequency of neuropathic pain (NP) in patients with low back pain (LBP) and the relationship of NP with demographic characteristics and pain duration. Four hundred and forty patients were evaluated with respect to NP. Demographic data were collected and Douleur Neuropathique 4 Questions (DN4) questionnaire was used to identify NP. Any difference in demographic characteristics or duration of pain was investigated between the patients with and without NP. Sociodemographic factors which are independently associated with NP were analyzed. According to DN4, 43.9% of the patients had NP. Mean age of the patients was 44.8 years (± 13.7). 343 (77.9%) of the patients had chronic LBP (more than 3 months). The patients with NP were older (p < 0.001), had higher BMI (p = 0.005) and longer LBP duration (p < 0.001) and had lower educational level (p 0.018). NP was significantly more common in unemployed patients and less common in high-activity employees (p 0.001). Logistic regression analyses identified that high-active workers' risk of having NP was 1.76 times lesser than other groups (office workers, housewives and retired patients). Nearly half of the patients with LBP were accompanied by NP. It was remarkably more common in sedentary patients and patients with low socioeconomic status. High physical activity at work was found to decrease the risk of having NP. Clinicians should emphasize on exercise training as a therapeutic intervention while LBP is being treated.

Cost comparison of two approaches to chiropractic care for patients with acute and sub-acute low Back pain care episodes: a cohort study.

BACKGROUND: Low back pain (LBP) imposes a costly burden upon patients, healthcare insurers, and society overall. Spinal manipulation as practiced by chiropractors has been found be cost-effective for treatment of LBP, but there is wide variation among chiropractors in their approach to clinical care, and the most cost-effective approach to chiropractic care is uncertain. To date, little has been published regarding the cost effectiveness of different approaches to chiropractic care. Thus, the current study presents a cost comparison between chiropractic approaches for patients with acute or subacute care episodes for low back pain. METHODS: We employed a retrospective cohort design to examine costs of chiropractic care among patients diagnosed with acute or subacute low back pain. The study time period ranged between 07/01/2016 and 12/22/2017. We compared cost outcomes for patients of two cohorts of chiropractors within health care system: Cohort 1) a general network of providers, and Cohort 2) a network providing conservative evidence-based care for rapid resolution of pain. We used generalized linear regression modeling to estimate the comparative influence of demographic and clinical factors on expenditures. RESULTS: A total of 25,621 unique patients were included in the analyses. The average cost per patient for Cohort 2 (mean allowed amount $252) was lower compared to Cohort 1 (mean allowed amount $326; 0.77, 95% CI 0.75-0.79, p < .001). Patient and clinician related factors such as health plan, provider region, and sex also significantly influenced costs. CONCLUSIONS: This study comprehensively analyzed cost data associated with the chiropractic care of adults with acute or sub-acute low back pain cared by two cohorts of chiropractic physicians. In general, providers in Cohort 2 were found to be significantly associated with lower costs for patient care as compared to Cohort 1. Utilization of a clinical model characterized by a patient-centered clinic approach and standardized, best-practice clinical protocols may offer lower cost when compared to non-standardized clinical approaches to chiropractic care.

Implementation of the Primary Spine Care Model in a Multi-Clinician Primary Care Setting: An Observational Cohort Study.

OBJECTIVE: The objective of this investigation was to compare the value of primary spine care (PSC) with usual care for management of patients with spine-related disorders (SRDs) within a primary care setting. METHODS: We retrospectively examined existing patient encounter data at 3 primary care sites within a multi-clinic health system. Designated clinicians serve in the role as PSC as the initial point of contact for spine patients, coordinate, and follow up for the duration of the episode of care. A PSC may be a chiropractor, physical therapist, or medical or osteopathic physician who has been trained to provide primary care for patients with SRDs. The PSC model of care had been introduced at site I (Lebanon, New Hampshire); sites II (Bedford, New Hampshire) and III (Nashua, New Hampshire) served as control sites where patients received usual care. To evaluate cost outcomes, we employed a controlled quasi-experimental design for analysis of health claims data. For analysis of clinical outcomes, we compared clinical records for PSC at site I and usual care at sites II and III, all with reference to usual care at site I. We examined clinical encounters occurring over a 24-month period, from February 1, 2016 through January 31, 2018. RESULTS: Primary spine care was associated with reduced total expenditures compared with usual care for SRDs. At site I, average per-patient expenditure was $162 in year 1 and $186 in year 2, compared with site II ($332 in year 1; $306 in year 2) and site III ($467 in year 1; $323 in year 2). CONCLUSION: Among patients with SRDs included in this study, implementation of the PSC model within a conventional primary care setting was associated with a trend toward reduced total expenditures for spine care compared with usual primary care. Implementation of PSC may lead to reduced costs and resource utilization, but may be no more effective than usual care regarding clinical outcomes.

Morphine Equivalent Dose-Days (MED-D): Predicting the Impact of Opioid Prescription on Total Workers' Compensation Claim Costs for Acute Low Back Pain.

OBJECTIVE: To assess the effect of morphine equivalent dose-days (MED-D) on the total cost for acute low back pain (LBP) workers' compensation claims. METHODS: Simple random samples of 123 opioid and 141 nonopioid acute LBP claims were obtained. Opioid claims were divided into low, medium, and high subgroups for MED-D, MED, and prescription duration. Subgroup mean total costs were compared to the nonopioid group using multivariate regression analyses. RESULTS: MED-D and prescription duration were each, respectively, associated with significantly increased total costs at both medium and high levels. Increasing MED had a negative association with total cost, though stratification by duration abrogated this perceived trend. Interaction testing indicated MED and duration together better explained cost than MED alone. CONCLUSION: MED-D is a better predictor of total cost in acute LBP claims than MED alone.

Opioid Prescribing Patterns for Low Back Pain Among Commercially Insured Children.

: Level of Evidence: 3.

Cost-effectiveness of physiotherapeutic interventions for low back pain: a systematic review.

BACKGROUND: Due to the rapid increase in healthcare costs of low back pain (LBP), it is important to provide clinically effective and cost-effective interventions to individuals with the condition. OBJECTIVE: To evaluate all recent economic evaluations of physiotherapeutic interventions for patients with LBP. DATA SOURCES: A literature search of Cumulative Index to Nursing and Allied Health Literature, MEDLINE, the National Health Service Economic Evaluation Database, Health Technology Assessment and Database of Abstracts of Review of Effects (January 2008 to October 2018) was undertaken. STUDY SELECTION: Randomised controlled trials and cohort studies that assessed the cost- effectiveness of physiotherapeutic interventions on patients with LBP compared with a control group were included in this review. A Consolidated Health Economic Evaluation Reporting Standards checklist was used to assess the quality of studies. DATA EXTRACTION/DATA SYNTHESIS: Two authors extracted data independently. A descriptive synthesis was conducted to summarise the data. RESULTS: In total, 1531 articles were identified and 11 studies met the inclusion criteria for this review. The total number of study participants in this review was 2633 and their ages ranged from 18 to 80 years. The duration of LBP in these patients ranged from 3 weeks to 1 year. Excluding one study, all studies reported that the physiotherapeutic intervention was cost-effective compared with the control arm. Meta-analysis was not possible due to heterogeneity of the studies. CONCLUSION: Although most studies in this review suggested that physiotherapeutic interventions were cost-effective, it is difficult to pool their results for conclusive evidence. Systematic review registration number CRD: 42018089773.

Influence of Psychosocial and Sociodemographic Variables on Sickness Leave and Disability in Patients with Work-Related Neck and Low Back Pain.

The purpose of this study was to describe the association between psychosocial factors in patients with work-related neck or low back pain (n = 129), in order to study sickness leave, its duration, the disability reported, and to analyze the relationship of these factors with different sociodemographic variables. This was a descriptive cross-sectional study. Data on kinesiophobia, catastrophizing, disability, and pain were gathered. Sociodemographic variables analyzed included sex, age, occupational, and educational level. Other data such as location of pain, sick leave status and duration of sickness absence were also collected. Educational level (p = 0.001), occupational level (p < 0.001), and kinesiophobia (p < 0.001) were found to be associated with sickness leave; kinesiophobia (b = 1.47, p = 0.002, r = 0.35) and catastrophizing (b = 0.72, p = 0.012, r = 0.28) were associated with the duration of sickness leave. Educational level (p =0.021), kinesiophobia (b = 1.69, p < 0.000, r = 0.505), catastrophizing (b = 0.76, p < 0.000, r = 0.372), and intensity of pain (b = 4.36, p < 0.000, r = 0.334) were associated with the degree of disability. In the context of occupational insurance providers, educational and occupational factors, as well as kinesiophobia and catastrophizing, may have an influence on sickness leave, its duration and the degree of disability reported.

Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans.

BACKGROUND: Yoga interventions can improve function and reduce pain in persons with chronic low back pain (cLBP). OBJECTIVE: Using data from a recent trial of yoga for military veterans with cLBP, we analyzed the incremental cost-effectiveness of yoga compared with usual care. METHODS: Participants (n=150) were randomized to either 2× weekly, 60-minute yoga sessions for 12 weeks, or to delayed treatment (DT). Outcomes were measured at 12 weeks, and 6 months. Quality-adjusted life years (QALYs) were measured using the EQ-5D scale. A 30% improvement on the Roland-Morris Disability Questionnaire (primary outcome) served as an additional effectiveness measure. Intervention costs including personnel, materials, and transportation were tracked during the study. Health care costs were obtained from patient medical records. Health care organization and societal perspectives were examined with a 12-month horizon. RESULTS: Incremental QALYs gained by the yoga group over 12 months were 0.043. Intervention costs to deliver yoga were $307/participant. Negligible differences in health care costs were found between groups. From the health care organization perspective, the incremental cost-effectiveness ratio to provide yoga was $4488/QALY. From the societal perspective, yoga was "dominant" providing both health benefit and cost savings. Probabilistic sensitivity analysis indicates an 89% chance of yoga being cost-effective at a willingness-to-pay of $50,000. A scenario comparing the costs of yoga and physical therapy suggest that yoga may produce similar results at a much lower cost. DISCUSSION/CONCLUSIONS: Yoga is a cost-effective treatment for reducing pain and disability among military veterans with cLBP.

The Economic and Social Burden of Low Back Pain in Spain: A National Assessment of the Economic and Social Impact of Low Back Pain in Spain.

STUDY DESIGN: Economic evaluation of the costs of low back pain (LBP) in Spain from a societal perspective, including direct and indirect costs, based on a national representative sample of the general population, the National Health Survey of 2017 (NHS 2017). OBJECTIVE: To estimate the costs attributable to LBP in Spain. SUMMARY OF BACKGROUND DATA: LBP has a high prevalence and is associated with lower quality of life, functional status, and increased use of health services. Studies that assess the socio-economic burden of LBP from a general population perspective have not been published yet in Spain. METHODS: Data from NHS 2017 were used. Direct costs (consultations-general practitioner, specialist and emergency departments-, diagnostic tests, hospitalizations, physiotherapy, psychologist, and medication consumption) and indirect costs (absenteeism and presenteeism) were assessed. Multivariate models were obtained to determine the independent attributable effect of LBP in each variable. Costs were determined through existing regional healthcare services public data. RESULTS: Prevalence of LBP was 17.1% for men and 24.5% for women, and increased with age, low educational status, higher body mass index, and was associated with less physical activity, and lower self-perceived health. Multivariate analysis demonstrated that LBP was independently associated with a significant increase both in the utilization of all health services and on work day losses. Attributable costs of LBP were 8945.6 million euros, of which 74.5% implied indirect costs, representing overall 0.68% of Spanish Gross Domestic Product. CONCLUSION: Spain is paying a heavy price for LBP, mostly associated with its significant impact on absenteeism and presenteeism, as well as a noteworthy effect on excess health services utilization. These findings underscore the need to address this considerable public health and social problem through interventions that address widely LBP and that have demonstrated to be cost-effective. LEVEL OF EVIDENCE: 3.

Cost-utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study).

OBJECTIVE: To evaluate the cost-utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study. DESIGN: A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial. SETTING: Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect. PARTICIPANTS: 180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91). INTERVENTIONS: Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days. MAIN OUTCOME MEASURES: Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER). RESULTS: Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; -3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%. CONCLUSIONS: Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02323412.

Update of Markov Model on the Cost-effectiveness of Nonpharmacologic Interventions for Chronic Low Back Pain Compared to Usual Care.

STUDY DESIGN: Markov model. OBJECTIVE: Further validity test of a previously published model. SUMMARY OF BACKGROUND DATA: The previous model was built using data from ten randomized trials and examined the 1-year effectiveness and cost-effectiveness of 17 nonpharmacologic interventions for chronic low back pain (CLBP), each compared to usual care alone. This update incorporated data from five additional trials. METHODS: Based on transition probabilities that were estimated using patient-level trial data, a hypothetical cohort of CLBP patients transitioned over time among four defined health states: high-impact chronic pain with substantial activity limitations; higher (moderate-impact) and lower (low-impact) pain without activity limitations; and no pain. As patients transitioned among health states, they accumulated quality-adjusted life-years, as well as healthcare and productivity costs. Costs and effects were calculated incremental to each study's version of usual care. RESULTS: From the societal perspective and assuming a typical patient mix (25% low-impact, 35% moderate-impact, and 40% high-impact chronic pain), most interventions-including those newly added-were cost-effective (<$50,000/QALY) and demonstrated cost savings. From the payer perspective, fewer were cost-saving, but the same number were cost-effective. Results for the new studies generally mirrored others using the same interventions-for example, cognitive behavioral therapy (CBT) and physical therapy. A new acupuncture study had similar effectiveness to other acupuncture studies, but higher usual care costs, resulting in higher cost savings. Two new yoga studies' results were similar, but both differed from those of the original yoga study. Mindfulness-based stress reduction was similar to CBT for a typical patient mix but was twice as effective for those with high-impact chronic pain. CONCLUSION: Markov modeling facilitates comparisons across interventions not directly compared in trials, using consistent outcome measures after balancing the baseline mix of patients. Outcomes also differed by pain impact level, emphasizing the need to measure CLBP subgroups. LEVEL OF EVIDENCE: N/A.

Time Between an Emergency Department Visit and Initiation of Physical Therapist Intervention: Health Care Utilization and Costs.

OBJECTIVE: The aim of this study was to examine the association between the length of time between an emergency department (ED) visit and the subsequent initiation of physical therapist intervention for low back pain (LBP) on 1-year LBP-related health care utilization (ie, surgery, advanced imaging, injections, long-term opioid use, ED visits) and costs. METHODS: This retrospective cohort study focused on individuals who consulted the ED for an initial visit for LBP. Claims from a single statewide, all-payers database were used. LBP-related health care use and costs for the 12 months after the ED visit were extracted. Poisson and general linear models weighted with inverse probability treatment weights were used to compare the outcomes of patients who attended physical therapy early or delayed after the ED visit. RESULTS: Compared with the delayed physical therapy group (n = 94), the early physical therapy group (n = 171) had a lower risk of receiving lumbar surgery (relative risk [RR] = 0.47, 95% CI = 0.26-0.86) and advanced imaging (RR = 0.72, 95% CI = 0.55-0.95), and they were less likely to have long-term opioid use (RR = 0.45, 95% CI = 0.28-0.76). The early physical therapy group incurred lower costs (mean = $3,806, 95% CI = $1,998-$4,184) than those in the delayed physical therapy group (mean = $8,689, 95% CI = $4,653-$12,727). CONCLUSION: Early physical therapy following an ED visit was associated with a reduced risk of using some types of health care and reduced health care costs in the 12 months following the ED visit. IMPACT STATEMENT: The ED is an entry point into the health care system for patients with LBP. Until now, the impact of the length of time between an ED visit and physical therapy for LBP has not been well understood. This study shows that swift initiation of physical therapy following an ED visit for LBP is associated with lower LBP-related health utilization for some important outcomes and lower LBP-related health care costs.

How effective and efficient are different exercise patterns in reducing back pain?

BACKGROUND: Exercise is considered an effective intervention to relieve chronic back pain. However, it is still unknown whether specific exercise patterns vary in terms of their efficiency and effectiveness. AIM: To investigate the differential health and economic effects of intensity, specificity and degree of subjective perceived physical exertion across five exercise patterns (endurance, gymnastics, fitness, back gymnastics, multimodal back exercise) in adults with back pain. DESIGN: Longitudinal observational cohort study over a period of 24 months. SETTING: Various non-therapeutic exercise facilities (e.g. outdoor, fitness centers, health insurance programs, sports clubs) across one federal state of Germany (Baden-Wuerttemberg). POPULATION: Adults with back pain (N.=2,542, Mean =46.9 years, 66% females, graded chronic back pain [GCPS] 1=40.5%, GCPS 2=27.3%, GCPS 3=20.7%, GCPS 4=11.5%). METHODS: Self-reported back pain (functional restrictions and pain = back pain function score, [BPFS]) and characteristics of exercising behavior (frequency, duration, type, physical exertion) were assessed at baseline and at 6, 12, 18 and 24 months. Direct medical costs for back disorders (international classification of diseases, dorsopathies: M40-M54) were compiled from health insurance records. RESULTS: Moderate- to high-intensity exercise patterns were effective in reducing back pain, particularly at lower levels of subjective perceived physical exertion. At these intensity levels, multimodal back exercise (i.e. exercising the spine-stabilizing muscles specifically, ergonomic training) was 14.5 times more effective than non-back specific fitness exercise in reducing BPFS. The beneficial effects of both exercise types increased with the initial severity of back pain. However, only multimodal back exercise (moderate- to high-intensity/high back specificity) was associated with a significant decrease in direct medical costs for back pain. CONCLUSIONS: Targeted exercise of the spine-stabilizing musculature at moderate to high intensities without maximum perceived exertion is effective and efficient in reducing back pain. CLINICAL REHABILITATION IMPACT: The combination of high-intensity and high-specificity exercises yielded a significant reduction in medical costs. However, the intensities in terms of muscular load in endurance training and gymnastics may not be sufficient to reduce back pain effectively.

Low back pain should be considered a health and research priority in Brazil: Lost productivity and healthcare costs between 2012 to 2016.

BACKGROUND: Low Back Pain (LBP) is associated with an increase in disability-adjusted life years, and increased risk of disability retirement and greater absenteeism in Brazil. Hence, evidence on healthcare and lost productivity costs due to LBP is of utmost importance to inform decision-makers. METHODS: Cost-of-illness study with top-down approach, and societal perspective. We extracted data from National databases, considering the period 2012-2016. Outpatient expenses included clinical, surgical, diagnosis, orthosis/prosthetics, and complementary actions. Inpatient care expenses included hospital and professional services, intensive care unit, and companion stay. For productivity losses, duration of work absence and associated information (work-related and non-work-related; value of the sickness absence benefit; age; gender; and economic activity) were analyzed. Lost productivity costs were calculated multiplying the absence from work (days) by the daily-benefit. RESULTS: The societal costs amounted to US$ 2.2 billion, and productivity losses represented 79% of the costs. Total healthcare expenses were estimated to US$ 460 million. We found more than 880,000 diagnostic images. Individuals with LBP were in total 59 million days absent from work between 2012-2016. The mean lost days absent from work per person, for each year investigated was, respectively, 88; 84; 83; 87; and 100. Men were more days absent from work than women. In addition, rural workers presented greater absence from work compared to other professional activities. CONCLUSION: Healthcare expenses and lost productivity costs due to LBP were substantial, hence, there is a need for improvement of health services and policies to deal with this increasing burden of illness. We found an extensive use of diagnostic imaging, which is rather discouraged by clinical guidelines. We assume that men were experiencing high levels of back pain disability compared with women, as they presented greater absenteeism and higher lost productivity costs.

One-stage posterior debridement, bone grafting fusion, and mono-segment vs. short-segment fixation for single-segment lumbar spinal tuberculosis: minimum 5-year follow-up outcomes.

BACKGROUND: To compare the clinical and radiological outcomes between posterior mono-segment and short-segment fixation combined with one-stage posterior debridement and bone grafting fusion in treating single-segment lumbar spinal tuberculosis (LSTB). METHODS: Sixty-two patients with single-segment LSTB treated by a posterior-only approach were divided into two groups: short-segment fixation (Group A, n = 32) and mono-segment fixation (Group B, n = 30). The clinical and radiographic outcomes were analyzed and compared between the two groups. RESULTS: The intraoperative bleeding volume, operation time, and hospitalization duration were lower in Group B than in Group A. All patients achieved the bony fusion criteria. The visual analog scale score, Japanese Orthopedic Association score, and Oswestry Disability Index were substantially improved 3 months postoperatively and at the last visit in both groups, with no significant difference between the two groups (P > 0.05). Kirkaldy-Willis functional evaluation at the final follow-up demonstrated that all patients in both groups achieved excellent or good results. The difference in the angle correction rate and correction loss between Groups A and B was not significant (P > 0.05). CONCLUSIONS: One-stage posterior debridement, bone grafting fusion, and mono-segment or short-segment fixation can provide satisfactory clinical and radiological outcomes. Mono-segment fixation is more suitable for the treatment of single-segment LSTB because the lumbar segments with normal motion can be preserved with less trauma, a shorter operation time, shorter hospitalization, and lower costs.

Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol.

INTRODUCTION: Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10 kHz SCS for this population. METHODS: This is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10 kHz SCS plus usual care (intervention group) or to sham 10 kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient. DISCUSSION: The outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10 kHz SCS for use in patients with CNLBP who have not had surgery. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03470766. Registered on 20 March 2018. DISCLAIMER: The views expressed here are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The NIHR had no role in the study design, writing of the manuscript or the decision to submit for publication. ROLES AND RESPONSIBILITIES: AK, SP, DP, SW, RST, AC, SE, LM, RD and JF all contributed to the trial design and to securing trial funding. AK, JR, SP, DP, and SE are involved in the recruitment, the intervention and the follow-up. SW will perform data collection and analysis. RST will be responsible for the statistical analysis, and RD will be responsible for the health economic analysis. All authors read and approved the final manuscript.

Comparing the short-term cost-effectiveness of epidural steroid injections and medical management alone for discogenic lumbar radiculopathy.

OBJECTIVE: Epidural steroid injections (ESIs) are a commonly used treatment strategy for low back pain and lumbar radiculopathy. However, their cost-effectiveness and ability to mediate long-term quality of life (QOL) improvements is debated. We sought to analyze the cost-effectiveness of lumbar epidural steroid injections (ESIs) compared to medical management alone for patients with lumbar radiculopathy and low back pain. PATIENTS AND METHODS: QOL outcomes were prospectively collected at 3- and 6-months following initial consultation. Metrics included the EuroQol-5 Dimensions (EQ-5D) questionnaire, the Pain Disability Questionnaire (PDQ), the Patient Health Questionnaire (PHQ-9) and the Visual Analogue Scale (VAS). Cost estimations were based on Medicare national payment amounts, median income, and missed workdays. A cost-utility analysis was performed based upon cost estimations and a cost-effectiveness threshold of $100,000/Quality-adjusted life year (QALY). RESULTS: One hundred forty-one patients met our inclusion/exclusion criteria; 89 received ESI and 52 were treated with medical management alone. Both cohorts showed improved EQ-5D scores at 3 months but were similar to one another: ESI (ΔEQ-5D = 0.06; p = 0.03) and medical-alone (ΔEQ-5D = 0.07; p = 0.03). No significant difference was seen between groups for total costs ($2,190 vs. $1,772; p = 0.18) or cost-utility ratios ($38,710/QALY vs. $27,313/QALY; p = 0.73). At both the 3-month and 6-month endpoints, absolute differences in cost-utility was driven by overall costs as opposed to QALY gains. Medical management alone was more cost effective at both points owing to lower expenditures, however these differences were not significant. No benefits were seen in either group on the EQ-5D or any of the patient reported outcomes at the 6-month time point. CONCLUSION: ESIs were not cost-effective at either the 3-month or 6-month follow-up period. At 3 months, ESIs provide similar improvements in QOL outcomes relative to medical management and at similar costs. At 6 months, neither ESIs nor conservative management provide significant improvements in QOL outcomes.