2005;30(20):231220. Risk of bias will be assessed using the modified version of the Quality in Prognostic Studies (QUIPs) tool, originally developed by Hayden et al. Health service organisations and Primary HealthNetworks to implement evidence-based pathwaysfor the management of low back painconsistentwith the care described in the Low Back PainClinical Care Standard (planned for publicationin late 2021). Pekkanen et al. Ann Intern Med. Therefore, the main objective is to systematically review and meta-analyse the natural course of pain and disability in patients with degenerative disorders of the lumbar spine such as spinal stenosis, spondylolisthesis, disc herniation, or discogenic low back pain after first-time LSF surgery. 8600 Rockville Pike Hayden JA, et al. For the purpose of Table 4, the term 'includes' means that a person who uses a wheelchair or certain walking aids may be considered under the criteria for these impairment rating levels and may meet the required descriptor for either 10 or 20 points. Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5.1. Where possible, data will be pooled and analysed within the same surgical procedure. Fritzell P, et al. In this systematic review and meta-analysis, it is necessary to anticipate on a few challenges. JBS is leading the protocol development and dissemination. Ostelo RW, et al. The mean Oswestry disability index changed favourably from 46.5 to 34 in the surgical group and from 44.8 to 36.1 in the . Introduction Aging of the population has been accompanied by an increase in adult spinal deformity (ASD) linked to de novo degenerative lumbar scoliosis (DLS). Cost effectiveness analysis of graft options in spinal fusion surgery using a Markov model. This systematic review and meta-analysis will provide an overview of the natural course of pain and disability in patients with degenerative disorders of the lumbar spine after first-time LSF surgery. 2005;5:13. PubMed Central In particular, there is lack of understanding of long-term outcomes after LSF [8]. Pain and disability outcome measures are primary outcomes and will be measured with, for example, Visual Analogue Scale (VAS), Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), Roland Disability Questionnaire (RDQ), or Quebec Back Pain Disability Questionnaire (QBPDQ). [. Cost-effectiveness of lumbar fusion and nonsurgical treatment for chronic low back pain in the Swedish Lumbar Spine Study: a multicenter, randomized, controlled trial from the Swedish Lumbar Spine Study Group. However, one of several descriptors may be sufficient for that rating when the word 'or' links the descriptors, such as that outlined at the 5-point impairment rating level on Table 4 where (1)(a), (b) or (c) must be met for a rating to be assigned. Some Tables also represent an increase in frequency of symptoms, which is reflective of the impairment rating level. Find out if you qualify for SSDI benefits. Important protocol changes will be submitted as amendments to the journal and registered in PROSPERO. Download the lumbar spinal fusion section of the Atlas to read more about context, data, key findings, interpretation and addressing variation: Why revisit the variation in lumbar spinal fusion? Pre-qualify in 60 seconds for up to $3,345 per month and 12 months back pay. First, there could be a high heterogeneity in used surgical procedures (e.g. 4d. We aimed to assess the effect of lumbar spine fusion (LSF) on disability, health-related quality of life and mortality in a 5-year follow-up, and to compare these results with the general population. Data provided by the US Department of Health and Human Services shows a substantial increase in hospitalizations for spinal fusion in the USA from 61,000 in 1993 to 296,211 in 2002 and over 451,000 in 2012 [4]. Results considering pain or disability will be reported for the entire population and per patient category (spinal stenosis, spondylolisthesis, disc herniation, discogenic low back pain). Percentages could improve the ability to interpret change between outcome measures [36]. Studies will be assessed based on the domains of representation of sample, definition of study sample, study attrition, outcome measurement, confounding, statistical analysis, provision of data, and blinding of outcomes (modified version: Additional file 4). Under the 10-point descriptor on Table 4 the person would meet (1)(c). HHS Vulnerability Disclosure, Help In determining whether the required descriptors for a specific impairment level are met or not, ALL the descriptors for that level must be considered and applied as set out in the descriptor. Where a person uses a wheelchair or certain walking aids (for example, a quad stick, crutches or walking frame), the correct impairment rating depends, among other factors, upon the extent to which they are independent or dependent on another persons assistance to mobilise while using a wheelchair or walking aids, and to transfer to and from a wheelchair. Orthopedics. 0 [updated March 2011]. 2014;27(5):297304. Clinical trials are difficult to conduct, so the Australian Spine Registry should collect data on patient outcomes to support audit and peer review. 2003;28(12):12909. In general, if there is any doubt about exclusion of the study, the study will proceed to the full-text screening stage to reduce the likelihood of excluding a relevant study. http://creativecommons.org/licenses/by/4.0/, http://creativecommons.org/publicdomain/zero/1.0/, Preferred Reporting Items for Systematic Reviews and Meta-Analyses. DRE category V is not to be used following spinal fusion where there is a persisting radiculopathy. Received 2016 Jan 6; Accepted 2016 Apr 25. This person is unable to bend forward to pick up a light object, such as a cup of coffee, placed at knee height without experiencing pain in their lower back. Acute low back pain: systematic review of its prognosis. (DOCX 27kb)Additional file 2: Table S1. Measuring inconsistency in meta-analyses. Ostelo RW et al. If you want to learn how to implement these strategies to get the VA benefits you deserve, click here to speak with a VA claim expert for free. Measuring inconsistency in meta-analyses. Unspecified dorsalgia (lumbar and lumbosacral) and other dorsalgia (lumbar and lumbosacral), 1%. Fu C et al. The data shows a completed copy of the PRISMA checklist to guide readers in assessment of the quality of the current review protocol article. This systematic review and meta-analysis will provide an overview of the natural course of pain and disability in patients with degenerative disorders of the lumbar spine after first-time LSF surgery. The data shows a completed copy of the PRISMA checklist to guide readers in assessment of the quality of the current review protocol article. Bydon M et al. 1) will be constructed to assess for possible publication bias. a report from the persons treating doctor, a report from a medical specialist confirming diagnosis of conditions commonly associated with spinal function impairment (such as, spinal cord injury, spinal stenosis, cervical spondylosis, lumbar radiculopathy, herniated or ruptured disc, spinal cord tumours, arthritis or osteoporosis involving the spine, or chronic pain affecting the spine). Neurosurg Focus. The authors declare that they have no competing interests. Functional impairment, disability, and quality of life (QOL . 'Work' is taken to refer to any work that exists in Australia, even if not within the persons locally accessible labour market. The 10-point descriptor requires that the person have a MODERATE functional impact on activities involving spinal function. In some cases, certain claimants may be entitled to disability benefits, both short-term and long-term, following a spinal fusion. Examples of corroborating evidence for the purpose of Table 4 include, but are not limited to: Act reference: Social Security (Tables for the Assessment of Work-related Impairment for Disability Support Pension) Determination 2023 Table 4 - Spinal Function, Policy reference: SS Guide 3.6.3.03 Guidelines to the rules for applying the Impairment Tables - information that must be taken into account in applying the Tables. Percentages could improve the ability to interpret change between outcome measures [36]. NK drafted the protocol and leads search of eligible studies. That is, it is a measure of spinal function, NOT upper limb function. Spine J. 2009;22(10):7556. Spine (Phila Pa 1976). TH will lead the statistical analyses. Example of a modified funnel plot; outcome versus total sample size. Mummaneni PV et al. 4b. Act reference: Social Security (Tables for the Assessment of Work-related Impairment for Disability Support Pension) Determination 2023 section 8(1) The impairment of a person must be assessed , Table 4 Spinal Function. Lumbar fusion versus nonoperative management for treatment of discogenic low back pain: a systematic review and meta-analysis of randomized controlled trials. Pekkanen L et al. This rating also includes a person who would not be able to move independently or move around using walking aids, such as a quad stick, crutches or walking frame without assistance and the person requires assistance from another person to walk on some surfaces, even when using a walking aid. Eur Spine J. Lumbar spinal fusion for degenerative disorders of the lumbar spine is frequently used, despite current research presenting inconclusive evidence. Assistance is defined in the instrument as assistance from another person, rather than any aids, equipment or assistive technology the person may use, unless specified otherwise (3.6.3.05). 5. Given that lumbar spinal fusion may make their backs stiff and make prolonged sitting on the floor difficult, the cultural lifestyle forcing them to sit on the floor for hours might make them feel much more disabled in their daily lives and negatively influence patient satisfaction. Statistical simulation: power method polynomials and other transformations. Table 4 requires that a person have functional impact when performing activities requiring the use of the spine. [36] (VAS 15, NRS 2, ODI 10, RDQ 5, QBPDQ 20) will be used to interpret results and draw conclusions regarding a satisfying or disappointing natural course of pain and disability after LSF. Where no consensus can be reached, a third party (AR) will arbitrate [27]. Similarly, the contribution of spinal fusion to the national bill in the USA increased from $4.3 billion to $33.9 billion between 1998 and 2008 [5]. The 5-point descriptor requires that the person have a MILD functional impact on activities involving spinal function. Analysis by remoteness and socioeconomic status, Analysis by Aboriginal and Torres Strait Islander status, High-quality research and outcome monitoring, Hover or click on maps and graphs for details of data points, Use the dropdown boxes at the bottom of graphs to select states and territories,SA3sor PHNs, Spinal stenosis (lumbar and lumbosacral), 36%, Lumbar and other intervertebral disc disorders with radiculopathy, 21%, Spondylolisthesis (lumbar and lumbosacral), 25%, Radiculopathy (lumbar and lumbosacral), 5%, Other specified intervertebral disc displacement, 5%, Lumbar and other intervertebral disc disorders with myelopathy, 1%. (DOCX 26kb). CAS Instead, use Table 4.2 in the Guidelines; Radiculopathy persisting after surgery is not accounted for by AMA5 Table 15-3, and incompletely by tables 15-4 and 15-5, which only refer to radiculopathy that has improved following surgery. Lumbar spine fusion for chronic low back pain due to degenerative disc disease: a systematic review. It is not possible to estimate rates of staged surgery across separate hospitalisations from these data. In summary, LSF is increasingly used as treatment of degenerative disorders of the lumbar spine while evidence seems to show inconclusive outcomes and questionable cost-effectiveness. Syst Rev 5, 72 (2016). Carragee EJ, Hurwitz EL, Weiner BK. (DOCX 25kb), Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols checklist. The analysis and maps are based on the usual residential address of the patient and not the location of the hospital. Demineralized bone matrix composite grafting for posterolateral spinal fusion. Dimar 2nd JR et al. Titles and abstracts (stage 1) followed by full-texts of potentially relevant studies (stage 2) will be independently screened by two reviewers (NK and TH). . Hospitalisations resulting from infection, tumours, injury and spinal deformities such as scoliosis are excluded from this analysis. Spinal function involves bending or turning the back, trunk or neck. sharing sensitive information, make sure youre on a federal The language of publication will not be restricted. Low back pain is common in older people. 2 Common indications for fusion are degenerative and isthmic spondylolisthesis and deformity corrections. Moreover, LSF is not without any risks given the incidence of graft-specific complications (5.410.0% [1416]) and revisions (2.06.9% [1721]). Important protocol changes will be submitted as amendments to the journal and registered in PROSPERO. (DOCX 26kb), Search strategy example. Risk of bias for each included study will be independently assessed by the same initial reviewers (NK and TH); the third reviewer (AR) will mediate in situations of disagreement. [36] (VAS 15, NRS 2, ODI 10, RDQ 5, QBPDQ 20) will be used to interpret results and draw conclusions regarding a satisfying or disappointing natural course of pain and disability after LSF. Therefore, a patient who was hospitalised for spinal fusion without decompression may have had a hospitalisation for decompression in the same data collection period. 2014;36(6):E5. The diagnosis of the condition causing the impairment must be made by an appropriately qualified medical practitioner and supported by corroborating medical evidence. Workforce issues there may not be enough clinicians who provide alternatives to surgery in some areas. In some 39(9): p. 780-781. Minimal important change values as provided by Ostelo et al. Data extracted for each study will include the following summary data: participants (setting and area), patient characteristics, duration of symptoms, outcomes (including scale and name of the questionnaire/instrument), surgical procedure, clinical care pathway, design, sample size, inclusion and exclusion criteria, and follow-up dates. Rajaee SS, et al. Consideration must also be given to whether the person can undertake the activity on a repetitive or habitual basis. NK, TH, and AR will perform the study selection, data extraction, and assessment of bias. The literature suggests 25% as low heterogeneity, 50% as moderate, and 75% as high [33]. The Fourth Atlas 2021 shows trends over time. Lumbar spinal fusion surgery has a role in treating a small number of people who have degenerative spinal disorders with nerve-related problems. The authors are academic staff at Radboud University Medical Centre, University of Birmingham, Bern University Hospital, and Maastricht University Medical Centre. Note 1: Individual descriptors or their parts must not be applied in isolation from one another. 4a. This does not necessarily mean all descriptors must be met, but all must be considered to determine which descriptors apply to the persons impairment. This is further clarified through the use of an example stating a person has severe difficulty standing after being seated in a dining chair. After decades, the disks under the fusion eventually degenerate, preventing the person from standing upright. Vaccaro AR, Stubbs HA, Block JE. Find out about variation in lumbar spinal fusion rates in the Fourth Australian Atlas of Healthcare Variation 2021. 2015;24(5):101730. Evidence for the effectiveness of lumbar spinal fusion to treat chronic low back pain is low quality and uncertain. PubMed Therefore, a patient who was hospitalised for spinal fusion without decompression may have had a hospitalisation for decompression in the same data collection period. Spine; The Spine Journal; European Spine Journal; Journal of Neurosurgery: Spine; International Journal of Spine Surgery; Global Spine Journal) and reference lists of included studies will be searched for further relevant studies. Moher D et al. It is not possible to estimate rates of staged surgery across separate hospitalisations from these data. A completed copy of the PRISMA checklist will be provided in the additional files (Additional file 5) (PROSPERO CRD42015026922). We conducted a random-effect meta-analysis on the basis of a systematic review with research quality grading according to Grading of . Rihn JA, et al. This includes a GP, an orthopaedic surgeon, a rheumatologist, a rehabilitation physician, or other relevant specialist. Note 3: If the person's impairment does not meet all required descriptors for a certain impairment level, the person's impairment cannot be rated at that level or at any higher level. Part of 2008;8(5):74755. Determination of the descriptor that best fits the person's impairment level must be based on the available medical evidence including the person's medical history, investigation results and clinical findings. a report from an allied health practitioner (such as, a physiotherapist, or occupational therapist), confirming loss of range of movement in the spine or other effects of spinal disease or injury. In addition, several studies analysing cost-effectiveness report questionable outcomes of LSF in patients with degenerative spondylolisthesis [1113]. Outcomes for single-level lumbar fusion: the role of bone morphogenetic protein. Carreon LY, Glassman SD, Howard J. Fusion and nonsurgical treatment for symptomatic lumbar degenerative disease: a systematic review of Oswestry Disability Index and MOS Short Form-36 outcomes. Secondly, it is possible that the continuous outcome data on the same construct needs to be converted to a 0 to 100 scale or percentage to increase comparability of data between studies [36]. Develop and implement scope of clinicalpractice models for surgeons undertakingspinal surgery, ii. Furthermore, Atlas et al. Report key performance indicators, trendsand adverse events in spinal surgery totheir governing body, consistent with theNSQHS Standards. Variance-weighted pooled estimates of outcomes will be calculated for the continuous data [29]. Surgical treatment of spinal stenosis with and without degenerative spondylolisthesis: cost-effectiveness after 2years. Rates are standardised to remove age and sex differences between populations. The secondary goal was to . While every descriptor requires consideration, in order to compare and contrast the descriptors to determine which impairment rating best reflects the level of functional impact resulting from a persons condition. Spine (Phila Pa 1976). 5). The results of this systematic review and meta-analysis may improve understanding of recovery after lumbar spinal fusion and improve lumbar spinal fusion management. There were 14,608hospitalisations for lumbar spinal fusion (with or without decompression), representing 24hospitalisations per 100,000people aged 18years and over (the Australian rate), The number of hospitalisations for lumbar spinal fusion (with or without decompression) across 307 local areas ranged from 7 to 87 per 100,000people, The rate of hospitalisation was 12.4 times as high in the area with the highest rate compared with the area with the lowest rate, 83% of lumbar spinal fusion hospitalisations were for privately funded patients. 2013;35(16):136470. FOIA In particular, there is lack of understanding of long-term outcomes after LSF [8]. Used to connect two more spinal vertebrae to limit motion, the procedure can lead to complications that can keep once-healthy workers sidelined for weeks on end. Vaccaro AR, Stubbs HA, Block JE. Virk S, Sandhu HS, Khan SN. Kalakoti P, et al. There was no funding for development of this review protocol and there will be no funding for performing the systematic review. Ann Intern Med. Traumatic injury or wear and tear on the spine during military service can cause chronic back pain, often leaving veterans with limited mobility, ongoing pain, and an inability to work. Chronic pain can be either a symptom of a condition impacting spinal function or a condition itself. Hospitalisations for the same patient have not been linked. For this rating to be assigned, the person MUST be able to carry out all activities in descriptor (1)(a), (b) and (c). van Tulder M et al. Your privacy choices/Manage cookies we use in the preference centre. It joins (fuses) two or more vertebrae to stop them from moving against each other. Therefore, LSF might not be effective for the entire heterogeneous group of patients [25]. open versus minimally invasive) as a result of lack of evidence regarding safety and efficacy of different procedures [38]. Journal of Statistical Software 43.1: CRC Press; 2009. Ultimately, the results may lead to changes in timing of adequate LSF management and decision making for both patients and surgeons.
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