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                                          • Image-guided spinal injections in treatment of chronic spinal pain: an overview of evidence-based guideline recommendations and specific focus on guidance techniques

                                          Image-guided spinal injections in treatment of chronic spinal pain: an overview of evidence-based guideline recommendations and specific focus on guidance techniques

                                          Adobestock-456376994-von-crystal-light
                                          Research area: High tech medicine

                                          Project leaders: Gregor Goetz

                                          Project team: Mirjana Huic (first author, HTA/EBM Center, Croatia), Gregor Götz (second author, AIHTA, Austria)
                                          Duration: April 2023 – October 2023
                                          Language: English (with German summary)
                                          Publication: HTA Project Report No. 156: https://eprints.aihta.at/1477/

                                           

                                           

                                           

                                          Background: Chronic spinal pain is the most prevalent chronic disease across the globe: the pain is most present in the low back with 43%, followed by the neck at around 32%, and the thoracic spine at 13%. Intervertebral discs, facet joints, sacroiliac joints, ligaments, fascia, muscles, and nerve root dura are proven pain generators in the spine [1]. According to the 2019 Austrian Health Survey, 1.9 million people reported having been affected by chronic low back pain or another chronic back condition in the past twelve months. Women are slightly more likely than men to be affected by chronic low back pain (27.3% and 24.5%, respectively). Chronic low back pain is second only to allergies among the most frequently mentioned chronic conditions among those under 45 years of age. In the 45-59 age group, chronic low back pain is the most frequently reported of all chronic conditions. In the 60-plus age group, chronic low back pain was surpassed only by hypertension. Chronic neck pain affected 19.5% of the population, and women also more often than men (24.8% and 14.0%, respectively). The Austrian Health Survey surveyed the health status of 15,461 people between October 2018 and September 2019. The results are representative of the Austrian population aged 15 years and older [2]. For those affected by back pain, a high burden arises from the chronic pain condition and from functional impairments. This leads to an impairment of the quality of life, inability to work as well as psychological and social consequences [3]. Years of poor posture and wear and tear often lead to disc damage, which is not immediately associated with pain. However, the typical shooting pain can be triggered at any time by a jerky twist of the spine or an awkward movement. Depending on the degree of damage, three forms of disc damage are distinguished; the disc protrusion (protrusion), the disc herniation (prolapse) and sequestered disc herniation (disc tissue enters the spinal canal). If the disc damage leads to nerve irritation, irritation or compression, this leads to more or less severe pain, which is referred to as radiculopathy or root irritation syndrome  [3]. Spinal canal stenosis (narrowing of the spinal canal) is usually caused by degenerative changes and can also lead to this radicular symptomatology [3]. Regarding the facet joints as one of the proven causes of chronic spinal pain, the prevalence of facet joint pain is 27% to 41% in the low back, 36% to 67% in the cervical spine; and 34% to 48% in the thoracic spine [7].

                                          Multiple treatment modalities are currently available for chronic spinal pain, e.g., image-guided spinal epidural injections, nerve root injections, facet joint injections, medial branch block injections with local anaesthetic and/or steroids [1, 4, 5][7].

                                          Image-guided epidural injections are one of the most performed procedures in managing chronic spinal pain with or without extremity pain. Epidural injections can be used in pain treatment and disability secondary to herniated discs, spinal stenosis, axial discogenic pain, and in post-surgery syndrome [1].  Epidural injections are provided through caudal, interlaminar, and transforaminal approaches. An interlaminar or transforaminal approach are used in the lumbar, cervical, or thoracic spine. Caudal procedures are performed for lumbosacral disorders. Caudal and interlaminar epidurals have been the common procedures, but more recently, transforaminal epidural injections, specifically in the lumbosacral spine, are used [1, 6].

                                          Different facet joint interventions are used for the management of chronic axial spinal pain when facet joints are the proven causes of pain, e.g., radiofrequency ablation, therapeutic facet joint medial branch nerve blocks, or intraarticular facet joint injections [7].

                                          Percutaneous adhesiolysis is another treatment modality provided through caudal, interlaminar and transforaminal approaches in the lumbar spine, in patients with the post-lumbar surgery syndrome and spinal stenosis which failed to respond to or poorly responded to noninterventional and nonsurgical conservative management and fluoroscopically directed epidural injections [1].

                                          Spinal injections, like epidural injections, nerve root injections for nerve-root blocks, facet joint injections and facet joint medial branch nerve injections, are image guided interventions, using fluoroscopy or computed tomography (CT), in reaching the correct anatomical target, documenting the needle placement and contrast distribution, to allow the identification of inadvertent punctures and the subsequent correction of the needle position [1, 8-10]. Other image-guided technologies like ultrasound or magnetic resonance imaging (MRI) have been used for needle guidance in spinal injections, but less frequently [9]. The indications, frequency, and total number of interventions are important issues to considered.

                                          According to an AWMF S2K guideline [11], computer tomography (CT) or fluoroscopy can be used as guidance techniques. The preferences with regard to training experience, resource availability as well as institutional policy often guides the choice whether CT or fluoroscopy is used as a guidance technique [12].

                                          Currently, it is not completely clear in which therapeutic indications the image-guided spinal injections (with local anaesthetic and/or steroids) should be used in treatment of chronic spinal pain according to (evidence-based) clinical guidelines.

                                          Project Objective and Research Questions: The goal of this project is to identify the therapeutic indications for use of image-guided spinal injections (with local anaesthetic and/or steroids) in treatment of chronic spinal pain based on clinical guidelines, and to perform a synopsis of evidence-based recommendations for each indication. The report will also address potential organisational and social aspects to support evidence-based decision-making process in Austria.

                                          The following research questions (RQ) will be answered:

                                          • RQ1: What recommendations for or against image-guided spinal injections (with local anaesthetic and/or steroids) are offered for specific indications by evidence-based guidelines in the treatment of chronic spinal pain?
                                          • RQ2: What role is attributed to CT-guided spinal injections in relation to the different imaging modalities?
                                          • RQ3: What are the potential organisational and social aspects on image-guided spinal injections (with local anaesthetic and/or steroids) in treatment of chronic spinal pain?

                                          Inclusion criteria for guideline synopsis and other domains

                                          Population

                                          Patients with chronic spinal pain (e.g., related to herniated discs, spinal stenosis, axial discogenic pain, and in post-surgery syndrome)

                                          Spinal areas: cervical, thoracic, lumbar, sacral

                                          Intervention

                                          Image-guided spinal injections (e.g., Epidural injections - access transforaminal, interlaminar, caudal, nerve root injections, facet joint injections and facet joint medial branch nerve injections) with local anaesthetic and/or steroids using different image technologies (e.g., CT, fluoroscopy, ultrasound, MRI).

                                          Control

                                          -

                                          Outcome

                                          (Evidence-based) clinical practice guideline recommendations: Indications, Level of Evidence (LoE) and Grade of Recommendation (GoR)

                                          Other Domains: Organisational and Social (according to the EUnetHTA Core HTA Model® 3.0) [13]

                                          i.e., on

                                          Organisational:

                                          • Implementation considerations (Facilities at different healthcare level, Specialists who perform the procedure, Accessibility, Resources availability, Training, Institutional policy, Quality assurance and monitoring system)

                                          Social:

                                          • Values and preferences of patients and physicians (i.e., on different image-guided technologies)

                                           

                                          Setting

                                          Countries of the Global North

                                          Study Design

                                          (Evidence-based) clinical guidelines

                                          Other Domains: Clinical guidelines and Systematic reviews (SRs)

                                          Publication period

                                          2018-2023

                                          Language

                                          English, German

                                           

                                          Potential organisational and social aspects will be assessed as well.

                                          Methods:

                                          Search for relevant recommendations in (evidence-based) clinical guidelines:

                                          • A systematic literature search of several databases (MEDLINE via Ovid, Embase, Centre for Research and Dissemination (CRD), Cochrane (CENTRAL) is performed first.
                                          • ·A targeted hand search in the GIN database and the National Guideline Clearinghouse complements the systematic search.

                                          Selection, evaluation and synopsis of the identified clinical guidelines (recommendations for specific treatment indications):

                                          • Clinical guideline selection by 2 researchers
                                          • Quality assessment [14]using AGREE-II (Appraisal of Guidelines for Research & Evaluation) by one person, control by second person
                                          • Extraction of recommendations for specific treatment indications in relation to different imaging-guided technologies (in addition to explicit recommendations, any statements about CT-guided injections will be also extracted)
                                          • Qualitative synthesis and comparison of recommendations

                                          Other Domains: Organisational and Social

                                          The selection of assessment elements for potential organisational and social aspects will be based on the EUnetHTA Core Model® Version 3.0 [13]. 

                                          Literature search (see above) for other domains - clinical guidelines and SRs, from January 2018 – June 2023.

                                          For other domain no quality assessment tool will be used. Descriptive analyses of information will be performed from the various sources explored.

                                          Timeplan

                                          Period

                                          Deliverable

                                          April/May 2023

                                          Scoping, project protocol, systematic literature search and targeted hand search for (evidence-based) clinical guidelines and systematic reviews

                                          Literature search for other domain elements (clinical guidelines and SRs)

                                          June/July 2023

                                          Guideline selection and sourcing, assessment of quality of guidelines using AGREE-II

                                          Data extracting for other domains

                                          August 2023

                                          Drafting the report

                                          September 2023

                                          Internal and external review

                                          October 2023

                                          Finalisation of the report, layout and publication of the report

                                          References:

                                          [1]          L. Manchikanti, N. N. Knezevic, A. Navani, P. J. Christo, G. Limerick, A. K. Calodney, et al. Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines. Pain Physician. 2021;24(S1):S27-s208.

                                          [2]          Statistics Austria. Österreichische Gesundheitsbefragung 2019. Hauptergebnisse des Austrian Health Interview Survey (ATHIS) und methodische Dokumentation 2020. 2020. Available from: https://www.statistik.at/fileadmin/publications/Oesterreichische-Gesundheitsbefragung2019_Hauptergebnisse.pdf.

                                          [3]          Öffentliches Gesundheitsportal Österreichs. Rückenschmerzen. 2021. Available from: https://www.gesundheit.gv.at/krankheiten/koerper/wirbelsaeule/bandscheibenvorfall.html.

                                          [4]          L. Manchikanti, E. Knezevic, R. E. Latchaw, N. N. Knezevic, S. Abdi, M. R. Sanapati, et al. Comparative Systematic Review and Meta-Analysis of Cochrane Review of Epidural Injections for Lumbar Radiculopathy or Sciatica. Pain Physician. 2022;25(7):E889-e916.

                                          [5]          D. Sayed, J. Grider, N. Strand, J. M. Hagedorn, S. Falowski, C. M. Lam, et al. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain. J Pain Res. 2022;15:3729-3832. Epub 20221206. DOI: 10.2147/jpr.S386879.

                                          [6]          L. Manchikanti, E. Knezevic, N. N. Knezevic, B. P. Vangala, M. R. Sanapati, S. Thota, et al. A Comparative Systematic Review and Meta-Analysis of 3 Routes of Administration of Epidural Injections in Lumbar Disc Herniation. Pain Physician. 2021;24(6):425-440.

                                          [7]          L. Manchikanti, A. D. Kaye, A. Soin, S. L. Albers, D. Beall, R. Latchaw, et al. Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines Facet Joint Interventions 2020 Guidelines. Pain Physician. 2020;23(3s):S1-s127.

                                          [8]          National Insitute for Health Care Excellence (NICE). Low back pain and sciatica in over 16s: assessment and management. 2016 [cited 20.04.2023]. Available from: https://www.nice.org.uk/guidance/ng59.

                                          [9]          S. Bogdanovic, R. Sutter and V. Zubler. Spine injections: the rationale for CT guidance. Skeletal Radiol. 2022. Epub 20220923. DOI: 10.1007/s00256-022-04188-1.

                                          [10]        D. Wang. Image Guidance Technologies for Interventional Pain Procedures: Ultrasound, Fluoroscopy, and CT. Curr Pain Headache Rep. 2018;22(1):6. Epub 20180126. DOI: 10.1007/s11916-018-0660-1.

                                          [11]        Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Leitlinie zur konservativen, operativen und rehabilitativen Versorgung bei Bandscheibenvorfällen mit radikulärer Symptomatik. 2021. Available from: https://register.awmf.org/de/start.

                                          [12]        W. E. Palmer. Spinal Injections for Pain Management. Radiology. 2016;281(3):669-688. DOI: 10.1148/radiol.2016152055.

                                          [13]        European network for Health Technology Assessment (EUnetHTA). HTA Core Model. Version 3.0. 2016. Available from: https://www.eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf.

                                          [14]        M. C. Brouwers, K. Kerkvliet and K. Spithoff. The AGREE Reporting Checklist: a tool to improve reporting of clinical practice guidelines. Bmj. 2016;352:i1152. Epub 20160308. DOI: 10.1136/bmj.i1152. 

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