Cost-effectiveness of posterior versus anterior surgery for cervical radiculopathy: results from a multicentre randomised non-inferiority trial (FACET).

PURPOSE: For cervical nerve root compression, anterior cervical discectomy with fusion (anterior surgery) or posterior foraminotomy (posterior surgery) are safe and effective options. Posterior surgery might have a more beneficial economic profile compared to anterior surgery. The purpose of this study was to analyse if posterior surgery is cost-effective compared to anterior surgery. METHODS: An economic evaluation was performed as part of a multicentre, noninferiority randomised clinical trial (Foraminotomy ACDF Cost-effectiveness Trial) with a follow-up of 2 years. Primary outcomes were cost-effectiveness based on arm pain (Visual Analogue Scale (VAS; 0-100)) and cost-utility (quality adjusted life years (QALYs)). Missing values were estimated with multiple imputations and bootstrap simulations were used to obtain confidence intervals (CIs). RESULTS: In total, 265 patients were randomised and 243 included in the analyses. The pooled mean decrease in VAS arm at 2-year follow-up was 44.2 in the posterior and 40.0 in the anterior group (mean difference, 4.2; 95% CI, - 4.7 to 12.9). Pooled mean QALYs were 1.58 (posterior) and 1.56 (anterior) (mean difference, 0.02; 95% CI, - 0.05 to 0.08). Societal costs were €28,046 for posterior and €30,086 for the anterior group, with lower health care costs for posterior (€12,248) versus anterior (€16,055). Bootstrapped results demonstrated similar effectiveness between groups with in general lower costs associated with posterior surgery. CONCLUSION: In patients with cervical radiculopathy, arm pain and QALYs were similar between posterior and anterior surgery. Posterior surgery was associated with lower costs and is therefore likely to be cost-effective compared with anterior surgery.

Clinical and cost-effectiveness of PCF versus ACD in the treatment of cervical brachialgia (FORVAD trial).

BACKGROUND: Cervical radiculopathy occurs when a nerve root is compressed in the spine, if symptoms fail to resolve after 6 weeks surgery may be indicated. Anterior Cervical Discectomy (ACD) is the commonest procedure, Posterior Cervical Foraminotomy (PCF) is an alternative that avoids the risk of damage to anterior neck structures. This prospective, Phase III, UK multicentre, open, individually randomised controlled trial was performed to determine whether PCF is superior to ACD in terms of improving clinical outcome as measured by the Neck Disability Index (NDI) 52 weeks post-surgery. METHOD: Following consent to participate and collection of baseline data, subjects with cervical brachialgia were randomised to ACD or PCF in a 1:1 ratio on the day of surgery. Clinical outcomes were assessed on day 1 and patient reported outcomes on day 1 and weeks 6, 12, 26, 39 and 52 post-operation. A total of 252 participants were planned to be randomised. Statistical analysis was limited to descriptive statistics. Health economic outcomes were also described. RESULTS: The trial was closed early (n = 23). Compared to baseline, the median (interquartile range (IQR)) NDI score at 52 weeks reduced from 44.0 (36.0, 62.0) to 25.3 (20.0, 42.0) in the PCF group and increased from 35.6 (34.0, 44.0) to 45.0 (20.0, 57.0) in the ACD group. ACD may be associated with more swallowing, voice and other complications and was more expensive; neck and arm pain scores were similar. CONCLUSIONS: The trial was closed early, therefore no definitive conclusions on clinical or cost-effectiveness could be made.

Integrating jigsaw puzzle thinking into practice: the assessment of cervical spine radiculopathy.

PURPOSE OF REVIEW: Cervical spine radiculopathy (CSR) presents a complex socioeconomic problem for patients, clinicians, families, employers and healthcare systems. Due to the heterogeneity of clinical presentation and underlying mechanisms, clinical assessment can be challenging. This review will examine the literature on the underlying pathophysiology and studies investigating the holistic assessment strategies for this disabling condition. The authors will focus particular attention on the psychological factors associated with CSR and the physical and imaging strategies to establish a diagnosis. RECENT FINDINGS: Contemporary CSR assessment should identify the underlying pathomechanisms and how this may impact the somatosensory nervous system integrity and function. No physical assessment test in isolation will establish CSR diagnosis; therefore, clinicians should utilise a cluster of tests and recognise the potential limitations as part of a clinical reasoning framework. The assessment of the somatosensory nervous system can provide insights into particular subgroups of CSR presentation, which may provide interesting opportunities to continue to enhance individualised assessment and management strategies for CSR. The interplay between psychological factors can influence the diagnosis and recovery times for a person with CSR, and clinicians should continue to explore how these factors may influence a person's prognosis. The authors will discuss the opportunities for future research and limitations of contemporary approaches to assessment, underpinned by evidence, and how this supports a clinical assessment to establish CSR diagnosis. SUMMARY: Research should continue to investigate how clinicians assess the interplay between physical and psychological factors to inform the establishment of CSR. Specifically, there is a need to investigate the validity and reliability of combining somatosensory, motor and imaging assessment findings to reach a diagnosis and inform onward management plans.

Effect of perioperative pain neuroscience education in people undergoing surgery for lumbar radiculopathy: a multicentre randomised controlled trial.

BACKGROUND: Perioperative education should be improved to decrease unfavourable outcomes after lumbar surgery. This trial aimed to compare effectiveness in terms of pain, quality of life, pain cognition, surgical experience, healthcare use, work resumption, and cost-effectiveness of perioperative pain neuroscience education (PPNE) vs traditional biomedical education (perioperative biomedical education [PBE]) in people undergoing surgery for lumbar radiculopathy. METHODS: In this multicentre RCT (ClinicalTrials.gov: NCT02630732), patients undergoing surgery for lumbar radiculopathy in three Belgian hospitals were randomised to receive PPNE or PBE. Both groups received one preoperative and one postoperative one-to-one education session and a booklet (balanced interventions), with an essentially different content (PPNE: biopsychosocial; PBE: biomedical). Pain was the primary outcome (Visual Analogue Scales+quantitative sensory testing). Assessments were at 3 days, 6 weeks, and 6 and 12 months after surgery. RESULTS: Between March 2016 and April 2020, participants were randomly assigned to PPNE (n=58) or PBE (n=62). At 12 months, PPNE did not lead to significantly better pain outcomes, but it did result in more favourable 36-item Short Form Health Survey physical component (additional increase: 46.94; 95% confidence interval [CI]: 14.16-79.73; medium effect), Tampa Scale of Kinesiophobia (additional decrease: 3.15; 95% CI: 0.25-6.04; small effect), and Pain Catastrophising Scale (additional decrease: 6.18; 95% CI: 1.97-10.39; medium effect) scores. Females of the PPNE group showed higher probability for work resumption (95% vs 60% in the PBE group). PPNE was cost-effective compared with PBE (incremental costs: €-2732; incremental quality-adjusted life years: 0.012). CONCLUSIONS: Perioperative pain neuroscience education showed superior clinical and cost-effectiveness than perioperative biomedical education in people undergoing surgery for lumbar radiculopathy. CLINICAL TRIAL REGISTRATION: NCT02630732.

Anterior Cervical Discectomy and Fusion Versus Microendoscopic Posterior Cervical Foraminotomy for Unilateral Cervical Radiculopathy: A 1-Year Cost-Utility Analysis.

BACKGROUND: Anterior cervical discectomy and fusion (ACDF) and posterior cervical foraminotomy (PCF) are the most common surgical approaches for medically refractory cervical radiculopathy. Rigorous cost-effectiveness studies comparing ACDF and PCF are lacking. OBJECTIVE: To assess the cost-utility of ACDF vs PCF performed in the ambulatory surgery center setting for Medicare and privately insured patients at 1-year follow-up. METHODS: A total of 323 patients who underwent 1-level ACDF (201) or PCF (122) at a single ambulatory surgery center were compared. Propensity matching generated 110 pairs (220 patients) for analysis. Demographic data, resource utilization, patient-reported outcome measures, and quality-adjusted life-years were assessed. Direct costs (1-year resource use × unit costs based on Medicare national allowable payment amounts) and indirect costs (missed workdays × average US daily wage) were recorded. Incremental cost-effectiveness ratios were calculated. RESULTS: Perioperative safety, 90-day readmission, and 1-year reoperation rates were similar between groups. Both groups experienced significant improvements in all patient-reported outcome measures at 3 months that was maintained at 12 months. The ACDF cohort had a significantly higher preoperative Neck Disability Index and a significantly greater improvement in health-state utility (ie, quality-adjusted life-years gained) at 12 months. ACDF was associated with significantly higher total costs at 1 year for both Medicare ($11 744) and privately insured ($21 228) patients. The incremental cost-effectiveness ratio for ACDF was $184 654 and $333 774 for Medicare and privately insured patients, respectively, reflecting poor cost-utility. CONCLUSION: Single-level ACDF may not be cost-effective in comparison with PCF for surgical management of unilateral cervical radiculopathy.

A Systematic Review of Clinical Practice Guidelines for Persons With Non-specific Low Back Pain With and Without Radiculopathy: Identification of Best Evidence for Rehabilitation to Develop the WHO's Package of Interventions for Rehabilitation.

OBJECTIVE: To Identify evidence-based rehabilitation interventions for persons with non-specific low back pain (LBP) with and without radiculopathy and to develop recommendations from high-quality clinical practice guidelines (CPGs) to inform the World Health Organization's (WHO) Package of Interventions for Rehabilitation (PIR). DATA SOURCE: We searched MEDLINE, EMBASE, CINAHL, PsycINFO, National Health Services Economic Evaluation Database, Health Technology Assessment Database, PEDro, the Trip Database, the Index to Chiropractic Literature and the gray literature. STUDY SELECTION: Eligible guidelines were (1) published between 2009 and 2019 in English, French, Italian, or Swedish; (2) included adults or children with non-specific LBP with or without radiculopathy; and (3) assessed the benefits of rehabilitation interventions on functioning. Pairs of independent reviewers assessed the quality of the CPGs using AGREE II. DATA SYNTHESIS: We identified 4 high-quality CPGs. Recommended interventions included (1) education about recovery expectations, self-management strategies, and maintenance of usual activities; (2) multimodal approaches incorporating education, exercise, and spinal manipulation; (3) nonsteroidal anti-inflammatory drugs combined with education in the acute stage; and (4) intensive interdisciplinary rehabilitation that includes exercise and cognitive/behavioral interventions for persistent pain. We did not identify high-quality CPGs for people younger than 16 years of age. CONCLUSION: We developed evidence-based recommendations from high-quality CPGs to inform the WHO PIR for people with LBP with and without radiculopathy. These recommendations emphasize the potential benefits of education, exercise, manual therapy, and cognitive/behavioral interventions.

Eficacia y seguridad del espaciador intervertebral cervical con sistema de bloqueo de anclaje en pacientes adultos con enfermedad degenerativa del disco cervical con mielopatía y/o radiculopatía que no responden al tratamiento conservador / Efficacy and safety of the cervical intervertebral spacer with anchor locking system in adult patients with degenerative cervical disc disease with myelopathy and/or radiculopathy who do not respond to conservative treatment

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021 y ampliada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 97-IETSI-ESSALUD2022, se ha elaborado el presente dictamen preliminar sobre la evaluación de la eficacia y seguridad del espaciador intervertebral cervical con sistema de bloqueo de anclaje en pacientes adultos con enfermedad degenerativa del disco cervical con mielopatía y/o radiculopatía que no responden al tratamiento conservador. ASPECTOS GENERALES: La enfermedad degenerativa del disco cervical es una causa muy frecuente de dolor de cuello a nivel mundial (Kazeminasab et al., 2022). Su etiología es multifactorial, siendo el envejecimiento el factor más relevante, donde el proceso degenerativo puede ..comenzar desde la segunda década de vida pasando por fases conocidas como disfunción, inestabilidad y estabilización hasta llegar a la senectud (Fakhoury & Dowling, 2022). De esta forma, se han reportado prevalencias de casi 30 % en menores de 50 años y cerca de 90 % en mayores de 80 años (Teraguchi et al., 2014). La degeneración cervical puede resultar en mielopatía y/o radiculopatía cervical. La mielopatía se refiere a la compresión o afección de la médula espinal a nivel del canal espinal, mientras que la radiculopatía se traduce en la compresión o afección de una o varias de sus raíces cervicales. La compresión suele ser debido a una hernia discal, presencia de osteofitos, masas adyacentes, espondilosis o estenosis congénita del canal espinal (McCartney et al., 2018). La incidencia de ambas han sido previamente reportadas, con 4 casos de mielopatía cervical por 100 000 personas-año (Nouri et al., 2015), y 107.3 casos de radiculopatía cervical en varones y 63.5 en mujeres por 100 000 personas-año (Radhakrishnan et al., 1994). METODOLOGÍA: Se realizó una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia sobre la eficacia y seguridad del espaciador intervertebral cervical con sistema de bloqueo de anclaje en pacientes adultos con enfermedad degenerativa del disco cervical con mielopatía y/o radiculopatía, que no responden al tratamiento conservador. La búsqueda bibliográfica se llevó a cabo en las bases de datos PubMed, The Cochrane Library, Web of Science y LILACS. Además, se realizó una búsqueda manual en Google y dentro de las páginas web pertenecientes a grupos que realizan evaluaciones de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC), incluyendo el Centro Nacional de Excelencia Tecnológica en Salud (CENETEC), National Institute for Health and Care Excellence (NICE), la Agency for Healthcare Research and Quality's (AHRQ), Scottish Intercollegiate Guidelines Network (SIGN), The Guidelines International Network (GIN), National Health and Medical Research Council (NHMRC), Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), Comissáo Nacional de Incorporacáo de Tecnologias no Sistema Único de Saúde (CONITEC), Instituto de Evaluación Tecnológica en Salud (IETS), Instituto de Efectividad Clínica y Sanitaria (IECS), Scottish Medicines Consortium (SMC), Canadian Agency for Drugs and Technologies in Health (CADTH), Instituto de Calidad y Eficiencia en la Atención de la Salud (IQWiG, por sus siglas en alemán), y Hauté Autorité de Santé (HAS). Asimismo, se realizó una búsqueda de GPC en las páginas web de las principales sociedades o instituciones especializadas el manejo de patologías de la médula espinal, tales como: Spine Intervention Society (SIS), Spine Society of Australia (SSA) y la Asia Pacific Spine Society (APOA). Finalmente, se realizó una búsqueda de estudios en curso aún no publicados en las páginas web de ClinicalTrials.govy la International Clinical Trials Registry Platform. RESULTADOS: La búsqueda bibliográfica se llevó a cabo el 18 de octubre de 2022. Se incluyeron dos GPC (Fehlings et al., 2017; Latka et al., 2016) que tuvieron recomendaciones relacionadas al procedimiento, pero no al dispositivo; una RS con metaanálisis en red (NMA, por sus siglas en inglés "Network meta-analysis") (Xu et al., 2020) que realizó comparaciones indirectas de la intervención y comparador de la pregunta PICO planteada con otros dispositivos que no formaron parte la presente ETS, motivo por el que se decidió identificar ECA. Es así que también se incluyó un ECA (Zhou et al., 2020) que no evaluó todos los desenlaces planteados en la pregunta PICO (tiempo quirúrgico y eventos adversos), por lo que se decidió incluir EO que contribuyan con estos desenlaces. De esta forma se incluyeron dos EO (Wang et al., 2015; Zhou et al., 2018) que tuvieron un diseño tipo cohorte retrospectiva. CONCLUSIÓN: Por lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e InvestigaciónIETSI aprueba el uso del espaciador intervertebral cervical con sistema de bloqueo de anclaje como tratamiento para los pacientes adultos con enfermedad degenerativa del disco cervical con mielopatía y/o radiculopatía que no responden al tratamiento conservador.

Cost effectiveness of implanting a prosthesis after anterior cervical discectomy for radiculopathy: results of the NECK randomized controlled trial.

BACKGROUND CONTEXT: In the treatment of cervical radiculopathy due to a herniated disc, potential surgical treatments include: anterior cervical discectomy (ACD), ACD and fusion using a cage (ACDF), and anterior cervical disc arthroplasty (ACDA). Previous publications yielded comparable clinical and radiological outcome data for the various implants, but research on their comparative costutility has been inconclusive. PURPOSE: To evaluate the cost utility of ACD, ACDF, and ACDA. STUDY DESIGN: Cost-utility analysis. PATIENT SAMPLE: About 109 patients with cervical radiculopathy randomized to undergo ACD, ACDF, or ACDA as part of the NEtherlands Cervical Kinetics trial. OUTCOME MEASURES: Quality-adjusted life-years (QALYs) estimated from patient-reported utilities using the EuroQol-5D questionnaire and EuroQol Visual Analogue Scale (EQ VAS), measured at baseline, 2, 4, 8, 12, 26, 52, and 104 weeks postprocedure. Societal costs including admissions to hospital (related and otherwise), GP visits, specialist visits, physical therapy, medications, home care, aids, informal care, productivity losses, and out of pocket condition-related expenses. METHODS: The cost utility of the competing strategies over 1 and 2 years was assessed following a net benefit (NB) approach, whereby the intervention with the highest NB among competing strategies is preferred. Cost effectiveness acceptability curves were produced to reflect the probability of each strategy being the most cost effective across various willingness-to-pay (WTP) thresholds. Five sensitivity analyses were conducted to assess the robustness of results. RESULTS: ACDF was more likely to be the most cost-effective strategy at WTP thresholds of €20,000 to 50,000/QALY in all but one of the analyses. The mean QALYs during the first year were 0.750, 0.817, and 0.807 for ACD, ACDF, and ACDA, respectively, with no significant differences between groups. Total healthcare costs over the first year were significantly higher for ACDA, largely due to the higher surgery and implant costs. The total societal costs of the three strategies were €12,173 for ACD, €11,195 for ACDF, and €13,746 for ACDA, with no significant differences between groups. CONCLUSION: Our findings demonstrate that ACDF is likely to be more cost-effective than ACDA or ACD at most WTP thresholds, and this conclusion is robust to most sensitivity analyses conducted. It is demonstrated that the difference in costs is mainly caused by the initial surgical costs and that there are only minimal differences in other costs during follow-up. Since clinical data are comparable between the groups, it is to the judgment of the patient and surgeon which intervention is applied.

Variation in Commercial Insurance Type Impacts Access to Cervical Spine Surgery.

INTRODUCTION: Prior literature has demonstrated that disparities exist in health care access and outcomes by insurance status, and patients with commercial plans fare better than those with Medicaid. However, variation may exist within commercial plans, which may impact care access. The purpose of our study was to determine the association between commercial health insurance plan type and access/time to surgery among patients with degenerative cervical conditions. METHODS: The MarketScan database (IBM Watson Health, Ann Arbor, MI) was utilized to identify the first instance of International Classification of Diseases-10-CM diagnosis codes for cervical myelopathy and radiculopathy. Patients 65 years old or below enrolled from 2015 to 2020 with a minimum of two years of continuous enrollment were included. Surgery for myelopathy included anterior cervical discectomy and fusion (ACDF), posterior cervical laminectomy and fusion, and laminoplasty, whereas surgery for radiculopathy included ACDF, cervical disk arthroplasty, and foraminotomy. The time between first diagnosis and surgery was determined. Insurance plan type was categorized as noncapitated (NC), non-high-deductible health plan, Health Management Organization-type partially or fully capitated plans, or high-deductible health plans (HDHP). Proportional hazards regression was utilized to compare time-to-incidence of surgery by plan type, adjusting for age, and sex. RESULTS: In total, 55,954 patients with cervical myelopathy and 705,117 patients with cervical radiculopathy were included. Mean follow-up was 537 and 657 days for myelopathy and radiculopathy, respectively. At two years postdiagnosis, 22.6% of myelopathy and 5.6% of radiculopathy patients were managed surgically. ACDF was the most common surgery for both myelopathy (85.7% of surgically managed patients) and radiculopathy (80.6%). The mean time to surgery for myelopathy was 101 days, and 196 days for radiculopathy. The most common plan type was NC for both myelopathy (81.5%, n=44,832) and radiculopathy (80.6%, n=559,109). Time-to-occurrence of surgery was significantly higher among both myelopathy and radiculopathy patients with capitated plans and HDHP versus NC plans, but the impact was significantly greater among those with radiculopathy than myelopathy (all P <0.05). CONCLUSIONS: Insurance plan structure has a significant impact on incidence of and on time-to-occurrence of surgery for patients with cervical degenerative conditions. Patients with HDHP plans may experience higher costs, potentially limiting access to care.

CT-guided vs. fluoroscopically guided transforaminal epidural steroid injections for lumbar radiculopathy: a comparison of efficacy, safety and cost.

INTRODUCTION: There are no formal guidelines for whether CT-guided or fluoroscopy-guided TFESI should be undertaken for patients with symptoms of lumbar nerve root irritation and corresponding nerve impingement. Here, we sought to compare the efficacy, safety and cost of computer tomography (CT)-guided and fluoroscopically guided transforaminal epidural steroid injection (TFESI). MATERIALS AND METHODS: All patients who underwent lumbar TFESI at our institution between June 2016 and June 2018 were identified. Six-week follow-up outcomes were categorised. The radiation doses and associated cost was retrieved from our institution's costing system. RESULTS: One hundred and sixteen patients were included (CT-50; fluoroscopy-56). There were no complications. More patients were discharged 6 weeks after CT-guided lumbar TFESI when compared with fluoroscopically guided TFESI (CT-23, fluoroscopy-14 (P = 0.027)). There was no difference in the number of patients who were referred to surgery (P = 0.18), for further pain management (P = 0.45), or for further TFESI (P = 0.43). The effective radiation dose was significantly higher for CT-guided TFESI (CT-5.73 mSv (3.87 to 7.76); fluoroscopy-0.55 mSv (0.11 to 1.4) (P < 0.01)). The total cost for CT-guided lumbar TFESI was £237.50 (£235 to £337), over £800 less than under fluoroscopic guidance (£1052 (£892.80 to £1298.00), P < 0.01)). Removing cost associated with staff and theatre use (staffing, theatre, medical indemnity and overheads) revealed CT-guided lumbar TFESI to be less expensive than if the procedure was fluoroscopy-guided-CT-guided: £132.6 (130.8 to 197.5); fluoroscopy: £237.4 (£209.2 to £271.9) (P = 0.019). CONCLUSIONS: CT-guided TFESI was associated with a higher discharge rate, a lower cost, but a ten times higher radiation dose when compared with fluoroscopically guided TFESI. Prospective studies are required to compare the efficacy of these procedures and to investigate how the radiation dose of CT-guided TFESI can be reduced without jeopardising efficacy or safety.

Is Kambin's Triangle Safe or Not for Percutaneous Endoscopic Transforaminal Oblique Fixation from the Posterior Corner in the Lumbar Spine: A Neuroimaging Anatomic Assessment.

BACKGROUND: Nerve root injury and dural tears are important complications in endoscopic spine techniques. Whether Kambin's triangle is safe or not is unknown for percutaneous endoscopic transforaminal oblique fixation from the posterior corner (PETOFPC) in lumbar spine. This study aimed to verify neural safety of PETOFPC and to define and evaluate the ideal operating target and actual safe working area in Kambin's triangle for PETOFPC. METHODS: Lumbar magnetic resonance imaging was performed in 60 outpatients. The distances from the working targets to exiting nerve roots and dural sac/traversing nerve roots in the coronal and sagittal planes (c1-c6, s1-s6) and the distances from the exiting roots to the dural sac/traversing nerve roots in the upper and lower endplate planes (d1 and d2) were measured and statistically analyzed. RESULTS: All coronal planes (c1-c6) first increased and then decreased; they gradually increased from L1-2, maximized in L4-5, and decreased slightly in L5-S1. In L1-2 through L5-S1, d1 and d2 gradually increased (F = 249.7, P < 0.0001; F = 511.7, P < 0.0001), d2 > d1 (P < 0.05). Values of d1 and d2 were smallest in L1-2 (6.71 ± 2.10 mm and 11.89 ± 2.55 mm) and largest in L5-S1 (13.37 ± 4.09 mm and 22.05 ± 3.96 mm). With the outward shift of the targets in the sagittal plane, both s1, s3, s5 and s2, s4, s6 gradually decreased (s1 > s3 > s5, s2 > s4 > s6). CONCLUSIONS: We calculated the ideal operating target and actual safe area and further proved that Kambin's triangle is safe enough for PETOFPC. PETOFPC is a promising technology and may have great clinical significance.

Reliability of modified-modified Schober's test for the assessment of lumbar range of motion.

OBJECTIVE: To determine the intra-rater reliability of modified-modified Schober's test for measuring lumbar flexion and extension in patients of lumbar radiculopathy. METHODS: The case-control reliability study was conducted at the University of Lahore Teaching Hospital, Lahore, Pakistan, from March to September 2020, and comprised lumbar radiculopathy patients of either gender aged 35-60 years in group A and healthy controls in group B. Lumbar flexion and extension were measured by the same examiner on three different occasions. A non-stretching measuring tape was used in which the first two measurements were taken using the modified-modified Schober's test on the same day with a difference of 5 minutes, and the third measurement was taken three days later to assess reliability. To assess the test-retest reliability, intraclass correlation coefficient was calculated through two-way random analysis of variance. Standard error of measurement and minimal detectable change were also calculated. Data was analysed using SPSS 25. RESULTS: Of the 40 subjects, 20(50%) were in group A with a mean age of 45.00±6.72 years, and 20(50%) were in group B with a mean age of 49.60±6.65 years. Overall, there were 16(40%) male and 24(60%) female subjects. Within-day lumbar flexion and extension measurements were highly reliable in controls (intraclass correlation coefficient 0.93 for flexion and 0.96 for extension) as well as in patients (intraclass correlation coefficient 0.94 for flexion and 0.95 for extension). The high values of intraclass correlation coefficient 0.91 for flexion and 0.94 for extension in the controls and 0.83 for flexion and 0.92 for extension in the patients showed high reliability also for between-days measurements. CONCLUSIONS: The modified-modified Schober's test appeared to be a highly reliable technique for the measurement of lumbar flexion and extension in patients of lumbar radiculopathy as well as in healthy controls.

Research protocol: Cervical Arthroplasty Cost Effectiveness Study (CACES): economic evaluation of anterior cervical discectomy with arthroplasty (ACDA) versus anterior cervical discectomy with fusion (ACDF) in the surgical treatment of cervical degenerative disc disease - a randomized controlled trial.

INTRODUCTION: To date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multi-level symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). The extent to which kinematics, surgery-induced fusion, natural history, and progression of disease play a role in the development of CASP remains unclear. Anterior cervical discectomy with arthroplasty (ACDA) is another treatment option that is thought to reduce the incidence of CASP by preserving motion in the operated segment. While ACDA is often discouraged, as the implant costs are higher while the clinical outcomes are similar to ACDF, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long term. METHODS AND ANALYSIS: In this randomized controlled trial, patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a healthcare and societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months until 4 years post-surgery. DISCUSSION: High-quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking; to date, there are no prospective trials from a societal perspective. Considering the aging of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question. TRIAL REGISTRATION: ClinicalTrials.gov NCT04623593. Registered on 29 September 2020.

A comparative study of a nerve block therapy with and without a deeply inserted acupotomy applied to hyeopcheok points for lumbosacral radiculopathy: Safety, effectiveness, cost-effectiveness (a randomized controlled, two-arm, parallel study, pilot study, assessor-blind).

INTRODUCTION: The prevalence of lumbosacral radiculopathy is estimated to be approximately 3% to 5% in patient populations. Lumbosacral radiculopathy is largely caused by a complex interaction between biomechanical and biochemical factors. Nerve block therapy (NBT) mainly treats lumbosacral radiculopathy by improving the biochemical factors, whereas acupotomy mainly focuses on improving the biomechanical factors. Therefore, it is thought that synergistic effects may be obtained for the treatment of lumbosacral radiculopathy when both NBT and acupotomy are combined. However, no study in China and Korea, where acupotomy is majorly provided, has reported the effects of such a combination treatment. Therefore, this study aimed to evaluate the safety, effectiveness, and cost-effectiveness of the concurrent use of a deeply inserted acupotomy and NBT for the treatment of lumbosacral radiculopathy. METHODS/DESIGN: This is an open-label, parallel, assessor-blinded, randomized controlled trial, which will include 50 patients with lumbosacral radiculopathy. After patients voluntarily agree to participate in the study, they will be screened, and will undergo necessary examinations and tests according to the protocol. Those who satisfy the selection criteria will be randomly assigned to either the NBT + acupotomy or NBT groups in a 1:1 ratio. Both groups will undergo 2 NBTs once every 2 weeks from 1 week after the screening test. The treatment group will receive additional acupotomy twice a week for 4 weeks. The primary endpoint is the Oswestry Disability Index, whereas the secondary endpoints are the Numeral Rating Scale, European Quality of Life 5-dimension, McGill pain Questionnaire, Roland-Morris Disability Questionnaire, safety assessment, and economic feasibility evaluation. The measurements will be made at 0, 2, 4, and 8 weeks. ETHICS AND DISSEMINATION: This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS20OISE0085). We intend to submit the results of the trial to a peer-reviewed journal and/or conferences.

High-Resolution 3D versus Standard-Resolution 2D T2-Weighted Turbo Spin Echo MRI for the Assessment of Lumbar Nerve Root Compromise.

Radiculopathy can be caused by nerve root irritation and nerve root compression at the level of the lateral recess or at the level of the intervertebral foramen. T2-weighted (T2w) MRI is considered essential to evaluate the nerve root and its course, starting at the lateral recess through the intervertebral foramen to the extraforaminal space. With the introduction of novel MRI acceleration techniques such as compressed SENSE, standard-resolution 2D T2w turbo spin echo (TSE) sequences with a slice-thickness of 3-4 mm can be replaced with high-resolution isotropic 3D T2w TSE sequences with sub-millimeter resolution without prolonging scan time. With high-resolution 3D MRI, the course of the nerve root can be visualized more precisely due to a detailed depiction of the anatomical situation and less partial volume effects, potentially allowing for a better detection of nerve root compromise. In this intra-individual comparison study, 55 patients with symptomatic unilateral singular nerve root radiculopathy underwent MRI with both 2D standard- and 3D high-resolution T2w TSE MRI sequences. Two readers graded the degree of lumbar lateral recess stenosis and lumbar foraminal stenosis twice on both image sets using previously validated grading systems in an effort to quantify the inter-readout and inter-sequence agreement of scores. Inter-readout agreement was high for both grading systems and for 2D and 3D imaging (Kappa = 0.823-0.945). Inter-sequence agreement was moderate for both lumbar lateral recess stenosis (Kappa = 0.55-0.577) and lumbar foraminal stenosis (Kappa = 0.543-0.572). The percentage of high degree stenosis with nerve root deformity increased from 16.4%/9.8% to 41.8-43.6%/34.1% from 2D to 3D images for lateral recess stenosis/foraminal stenosis, respectively. Therefore, we show that while inter-readout agreement of grading systems is high for both standard- and high-resolution imaging, the latter outperforms standard-resolution imaging for the visualization of lumbar nerve root compromise.

Microdiscectomy Is More Cost-effective Than a 6-Month Nonsurgical Care Regimen for Chronic Radiculopathy.

BACKGROUND: A recent randomized controlled trial (RCT), performed by the authors, comparing early surgical microdiscectomy with 6 months of nonoperative care for chronic lumbar radiculopathy showed that early surgery resulted in improved outcomes. However, estimates of the incremental cost-utility ratio (ICUR), which is often expressed as the cost of gaining one quality-adjusted life year (QALY), of microdiscectomy versus nonsurgical management have varied. Radiculopathy lasting more than 4 months is less likely to improve without surgical intervention and may have a more favorable ICUR than previously reported for acute radiculopathy. QUESTION/PURPOSE: In the setting of chronic radiculopathy caused by lumbar disc herniation, defined as symptoms and/or signs of 4 to 12 months duration, is surgical management more cost-effective than 6 months of nonoperative care from the third-party payer perspective based on a willingness to pay of less than CAD 50,000/QALY? METHODS: A decision analysis model served as the vehicle for the cost-utility analysis. A decision tree was parameterized using data from our single-center RCT that was augmented with institutional microcost data from the Ontario Case Costing Initiative. Bottom-up case costing methodology generates more accurate cost estimates, although institutional costs are known to vary. There were no major surgical cost drivers such as implants or bone graft substitutes, and therefore, the jurisdictional variance would be minimal for tertiary care centers. QALYs derived from the EuroQoL-5D were the health outcome and were derived exclusively from the RCT data, given the paucity of studies evaluating the surgical treatment of lumbar radiculopathy lasting 4 to 12 months. Cost-effectiveness was assessed using the ICUR and a threshold of willingness to pay CAD 50,000 (USD 41,220) per QALY in the base case. Sensitivity analyses were performed to account for the uncertainties within the estimate of cost utility, using both a probabilistic sensitivity analysis and two one-way sensitivity analyses with varying crossover rates after the 6-month nonsurgical treatment had concluded. RESULTS: Early surgical treatment of patients with chronic lumbar radiculopathy (defined as symptoms of 4 to 12 months duration) was cost-effective, in that the cost of one QALY was lower than the CAD 50,000 threshold (note: the purchasing power parity conversion factor between the Canadian dollar (CAD) and the US dollar (USD) for 2019 was 1 USD = 1.213 CAD; therefore, our threshold was USD 41,220). Patients in the early surgical treatment group had higher expected costs (CAD 4118 [95% CI 3429 to 4867]) than those with nonsurgical treatment (CAD 2377 [95% CI 1622 to 3518]), but they had better expected health outcomes (1.48 QALYs [95% CI 1.39 to 1.57] versus 1.30 [95% CI 1.22 to 1.37]). The ICUR was CAD 5822 per QALY gained (95% CI 3029 to 30,461). The 2-year probabilistic sensitivity analysis demonstrated that the likelihood that early surgical treatment was cost-effective was 0.99 at the willingness-to-pay threshold, as did the one-way sensitivity analyses. CONCLUSION: Early surgery is cost-effective compared with nonoperative care in patients who have had chronic sciatica for 4 to 12 months. Decision-makers should ensure adequate funding to allow timely access to surgical care given that it is highly likely that early surgical intervention is potentially cost-effective in single-payer systems. Future work should focus on both the clinical effectiveness of the treatment of chronic radiculopathy and the costs of these treatments from a societal perspective to account for occupational absences and lost patient productivity. Parallel cost-utility analyses are critical so that appropriate decisions about resource allocation can be made. LEVEL OF EVIDENCE: Level III, economic and decision analysis.

Diagnostic performance of diffusion-weighted MR neurography as an adjunct to conventional MRI for the assessment of brachial plexus pathology.

OBJECTIVE: To investigate the diagnostic performance of diffusion-weighted (DW) MR neurography as an adjunct to conventional MRI for the assessment of brachial plexus pathology. METHODS: DW MR neurography scans (short tau inversion recovery fat suppression and b-value of 800 s/mm2) of 15 consecutive patients with and 45 randomly selected patients without brachial plexus abnormalities were independently and blindly reviewed by a 5th year radiology resident, a junior neuroradiologist, and a senior neuroradiologist. RESULTS: Median interpretation times ranged between 20 and 30 s. Interobserver agreement was substantial (κ coefficients of 0.715-0.739). For the 5th year radiology resident, sensitivity was 53.3% (95% CI, 30.1-75.2%) and specificity was 100% (95% CI, 92.1-100%). For the junior neuroradiologist, sensitivity was 66.7% (95% CI, 41.7-84.8%) and specificity was 100% (95% CI, 92.1-100%). For the senior neuroradiologist, sensitivity was 73.3% (95% CI, 48.1-89.1%) and specificity was 95.6% (95% CI, 85.2-98.8%). Traumatic injury, metastases, radiation-induced plexopathy, schwannoma, and inflammatory process of unknown cause could be detected by the majority of readers (100% detection rate for each disease entity by at least two readers). Neuralgic amyotrophy, iatrogenic injury after first rib resection, and cervical disc herniation causing root compression were not detected by the majority of readers (0% detection rate for each disease entity by at least two readers). CONCLUSION: DW MR neurography may be a useful adjunct when assessing for brachial plexus abnormalities, because interpretation time is relatively short and the majority of abnormalities can be detected. KEY POINTS: • DW MR neurography interpretation time of the brachial plexus is relatively short (median interpretation times of 20 to 30 s). • Interobserver agreement between three readers with different levels of experience is substantial (κ coefficients of 0.715 to 0.739). • DW MR neurography can detect brachial plexus abnormalities with moderate sensitivity (53.3 to 73.3%) and high specificity (95.6 to 100%).