Pain Management Injection Therapies For Low Back Pain

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Technology AssessmentPain Management InjectionTherapies for Low Back PainTechnologyAssessment ProgramPrepared for:Agency for HealthcareResearch and Quality540 Gaither RoadRockville, Maryland 20850FinalOriginal Publication: March 20, 2015Revised Publication: July 10, 2015

ErratumIn Table 1 and Appendix E1, patient characteristics, number analyzed, and pain scores were edited toreflect 24 month followup data for one trial publication.1 In Table 1 and Appendix E1, a correction wasmade to note that imaging correlation was required for one trial (with two publications). 2, 3 The qualityrating for this same trial was changed from fair to good in Table 1 to match the rating in Appendix E1.2, 3These edits do not affect the report conclusions.References1.2.3.Manchikanti L, Singh V, Cash KA, Pampati V, Falco FJ. A randomized, double-blind, active-control trialof the effectiveness of lumbar interlaminar epidural injections in disc herniation. Pain Physician.2014;17(1):E61-74. PMID: 24452658.Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment oflumbar radicular pain. Pain Med. 2010 Aug;11(8):1149-68. PMID: 20704666.Ghahreman A, Bogduk N. Predictors of a favorable response to transforaminal injection of steroids inpatients with lumbar radicular pain due to disc herniation. Pain Med. 2011;12(6):871-9. PMID: 21539702.i

Pain Management Injection Therapiesfor Low Back PainTechnology Assessment ReportProject ID: ESIB0813Original Publication: March 20, 2015Revised Publication: July 10, 2015Pacific Northwest Evidence-based Practice CenterRoger Chou, MD, FACPRobin Hashimoto, PhDJanna Friedly, MDRochelle Fu, PhDTracy Dana, MLSSean Sullivan, PhDChristina Bougatsos, MPHJeffrey Jarvik, MD, MPHii

This report is based on research conducted by the Pacific Northwest Evidence-basedPractice Center (EPC) under contract to the Agency for Healthcare Research and Quality(AHRQ), Rockville, MD (Contract No. HHSA 290-2012-00014-I). The findings andconclusions in this document are those of the author(s) who are responsible for itscontents; the findings and conclusions do not necessarily represent the views of AHRQ.No statement in this article should be construed as an official position of the Agency forHealthcare Research and Quality or of the U.S. Department of Health and HumanServices.The information in this report is intended to help health care decision-makers; patientsand clinicians, health system leaders, and policymakers, make well-informed decisionsand thereby improve the quality of health care services. This report is not intended to be asubstitute for the application of clinical judgment. Decisions concerning the provision ofclinical care should consider this report in the same way as any medical reference and inconjunction with all other pertinent information, i.e., in the context of available resourcesand circumstances presented by individual patients.AHRQ or U.S. Department of Health and Human Services endorsement of any derivativeproducts that may be developed from this report, such as clinical practice guidelines,other quality enhancement tools, or reimbursement or coverage policies may not be statedor implied.This document is in the public domain and may be used and reprinted without specialpermission. Citation of the source is appreciated.Persons using assistive technology may not be able to fully access information in this report. Forassistance contact TAP@ahrq.hhs.govNone of the investigators have any affiliations or financial involvement that conflicts withthe material presented in this report.Suggested citation. Chou R, Hashimoto R, Friedly J, Fu Rochelle, Dana T, Sullivan S,Bougatsos C, Jarvik J. Pain Management Injection Therapies for Low Back Pain. TechnologyAssessment Report ESIB0813. (Prepared by the Pacific Northwest Evidence-based PracticeCenter under Contract No. HHSA 290-2012-00014-I.) Rockville, MD: Agency for HealthcareResearch and Quality; July 2015.iii

AcknowledgmentsWe thank Rebecca Holmes, M.D., Ian Blazina M.P.H., and Alex Ginsburg, M.A., M.C.R.P.for assistance with data abstraction; Sara Grusing, B.A., for assistance with the EndNote library;and Leah Williams, B.S., for editorial support; Oregon Health and Science University.Key InformantsIn designing the study questions, the Evidence-based Practice Center (EPC) consulted severalKey Informants who represent the end-users of research. The EPC sought the Key Informantinput on the priority areas for research and synthesis. Key Informants are not involved in theanalysis of the evidence or the writing of the report. Therefore, in the end, study questions,design, methodological approaches, and/or conclusions do not necessarily represent the views ofindividual Key Informants.Key Informants must disclose any financial conflicts of interest greater than 10,000 and anyother relevant business or professional conflicts of interest. Because of their role as end-users,individuals with potential conflicts may be retained. The Task Order Officer and the EPC workto balance, manage, or mitigate any conflicts of interest.The list of Key Informants who participated in developing this report follows:Charles Argoff, M.D.Professor of Neurology, Albany MedicalCollegeDirector, Comprehensive Pain Center,Albany Medical CenterAlbany, NYSteven Cohen, M.D.Professor, Departments of Anesthesiology &Critical Care Medicine & Physical Medicine& RehabilitationDirector, Blaustein Pain Treatment CenterJohns Hopkins School of MedicineBaltimore, MDProfessor, Department of Anesthesiology &Physical Medicine & RehabilitationUniformed Services University of the HealthSciencesBethesda, MDJohn Carrino, M.D., M.P.H.Associate Professor, Russell H. MorganDepartment of Radiology and RadiologicalScience ; Associate Professor, Departmentof Orthopaedic Surgery, Johns HopkinsUniversity School of MedicineSection Chief, Musculoskeletal Radiology,Johns Hopkins HospitalBaltimore, M.D.Penney CowanExecutive Director, American Chronic PainAssociationRocklin, CAiv

Richard Deyo, M.D., M.P.H.Professor, Family Medicine, Department ofMedicine, Department of Public Health andPreventive Medicine, Center for Research inOccupational and EnvironmentalToxicology/School of Medicine, OregonHealth and Science UniversityPortland, ORMary Scott, B.A.Patient RepresentativeThorp, WASteven Stanos, D.O.Associate Professor, Department of PhysicalMedicine and Rehabilitation; AssistantProgram Director, Multidisciplinary PainFellowshipNorthwestern University Medical School,Feinberg School of MedicineChicago, ILGary Franklin, M.D., M.P.H.Medical Director, Washington StateDepartment of Labor and IndustriesChair, Washington Agency MedicalDirector’s GroupResearch Professor, Departments ofEnvironmental and Occupational HealthSciences,Neurology, and Health Services, Universityof WashingtonSeattle, WashingtonTechnical Expert PanelIn place of a Technical Expert Panel, CMS provided input to the Key Questions and scope ofthe report.Peer ReviewersPrior to publication of the final evidence report, the EPC sought input from independent PeerReviewers without financial conflicts of interest. However, the conclusions and synthesis of thescientific literature presented in this report does not necessarily represent the views of individualreviewers.Peer Reviewers must disclose any financial conflicts of interest greater than 10,000 and anyother relevant business or professional conflicts of interest. Because of their unique clinical orcontent expertise, individuals with potential non-financial conflicts may be retained. The TaskOrder Officer and the EPC work to balance, manage, or mitigate any potential non-financialconflicts of interest identified.The list of Peer Reviewers follows:v

Gary Franklin, M.D., M.P.H.Medical Director, Washington StateDepartment of Labor and IndustriesChair, Washington Agency MedicalDirector’s GroupResearch Professor, Departments ofEnvironmental and Occupational HealthSciences,Neurology, and Health Services, Universityof WashingtonSeattle, WashingtonCharles Argoff, M.D.Professor of Neurology, Albany MedicalCollegeDirector, Comprehensive Pain Center,Albany Medical CenterAlbany, NYSteven Cohen, M.D.Professor, Departments of Anesthesiology &Critical Care Medicine & Physical Medicine& RehabilitationDirector, Blaustein Pain Treatment CenterJohns Hopkins School of MedicineBaltimore, MDProfessor, Department of Anesthesiology &Physical Medicine & RehabilitationUniformed Services University of the HealthSciencesBethesda, MDMartin Grabois, M.D.Professor for Physical Medicine andRehabilitationBaylor College Medical CenterHouston, TXErin E. Krebs, M.D., M.P.H.Women's Health Medical Director,Minneapolis VA Health Care System;Associate Professor, Department ofMedicine, University of Minnesota,Minneapolis, MNGilbert Fanciullo, M.D., M.S.Director, Section of Pain MedicineDartmouth Hitchcock Medical CenterProfessor, Geisel School of Medicine atDartmouthHanover, NHTimothy Maus, M.D.Associate Professor of RadiologyMayo ClinicRochester, Minnesota, USAMark Wallace, M.D.Chair, Division of Pain Medicine; Professorof Clinical AnesthesiologyUniversity of California, San DiegoSan Diego, CAvi

Pain Management Injection Therapies for Low BackPainStructured AbstractObjectives. Low back pain is common and injections with corticosteroids are a frequently usedtreatment option. This report reviews the current evidence on effectiveness and harms ofepidural, facet joint, and sacroiliac corticosteroid injections for low back pain conditions.Data Sources. A prior systematic review (searches through July 2008), electronic databases(Ovid MEDLINE, Scopus, and the Cochrane Libraries from January 2008 through October2014), reference lists, and clinical trials registries.Review Methods. Using predefined criteria, we selected randomized trials of patients withlumbosacral radiculopathy, spinal stenosis, nonradicular back pain, or chronic postsurgical backpain that compared effectiveness or harms of epidural, facet joint, or sacroiliac corticosteroidinjections versus placebo or other interventions. We also included randomized trials thatcompared different injection techniques and large (sample sizes 1000) observational studies ofback injections that reported harms. The quality of included studies was assessed, data wereextracted, and results were summarized qualitatively and using meta-analysis on outcomesstratified by immediate- (1 week to 2 weeks), short- (2 weeks to 3 months), intermediate- (3months to 1 year), and long-term ( 1 year) followup.Results. Seventy-eight randomized trials of epidural injections, 13 trials of facet joint injections,and one trial of sacroiliac injections were included. For epidural corticosteroid injections versusplacebo interventions for radiculopathy, the only statistically significant effects were on meanimprovement in pain at immediate-term followup (weighted mean difference [WMD] ‒7.55 on a0 to 100 scale, 95% CI ‒11.4 to ‒3.74) (strength of evidence [SOE]: moderate), meanimprovement in function at immediate-term followup when an outlier trial was excluded(standardized mean difference [SMD] ‒0.33, 95% CI ‒0.56 to ‒0.09) (SOE: low), and risk ofsurgery at short-term followup (relative risk [RR] 0.62, 95% CI 0.41 to 0.92) (SOE: low). Themagnitude of effects on pain and function was small, did not meet predefined thresholds forminimum clinically important differences, and there were no differences on outcomes at longerterm followup. Evidence on effects of different injection techniques, patient characteristics, orcomparator interventions estimates was limited and did not show clear effects. Trials of epiduralcorticosteroid injections for radiculopathy versus nonplacebo interventions did not clearlydemonstrate effectiveness (SOE: insufficient to low).Evidence was limited for epidural corticosteroid injections versus placebo interventions forspinal stenosis (SOE: low to moderate) or nonradicular back pain (SOE: low), but showed nodifferences in pain, function, or likelihood of surgery.Studies found no clear differences between various facet joint corticosteroid injections (intraarticular, extra-articular [peri-capsular], or medial branch) and placebo interventions (SOE: lowto moderate). There was insufficient evidence from one very small trial to determine effects ofperi-articular sacroiliac joint corticosteroid injections injection (SOE: insufficient).vii

Serious harms from injections were rare in randomized trials and observational studies, butharms reporting was suboptimal (SOE: low).Conclusions: Epidural corticosteroid injections for radiculopathy were associated withimmediate improvements in pain and might be associated with immediate improvements infunction, but benefits were small and not sustained, and there was no effect on long-term risk ofsurgery. Evidence did not suggest that effectiveness varies based on injection technique,corticosteroid, dose, or comparator. Limited evidence suggested that epidural corticosteroidinjections are not effective for spinal stenosis or nonradicular back pain and that facet jointcorticosteroid injections are not effective for presumed facet joint pain. There was insufficientevidence to evaluate effectiveness of sacroiliac joint corticosteroid injections.viii

ContentsExecutive Summary . ES-1Introduction. 1Background . 1Scope of Review and Key Questions. 2Methods. 4Input From Stakeholders. 4Literature Search Strategy. 4Study Selection . 5Data Extraction . 6Assessing Quality. 6Assessing Research Applicability. 7Evidence Synthesis and Rating the Body of Evidence . 7Peer Review and Public Commentary . 9Results . 10Key Question 1. In patients with low back pain, what is the effectiveness of epiduralcorticosteroid injections, facet joint corticosteroid injections, medial branch blocks, andsacroiliac joint corticosteroid injections versus epidural nonsteroid injection, nonepiduralinjection, no injection, surgery or nonsurgical therapies on outcomes related to pain, functionand quality of life? . 14Key Points. 14Detailed Synthesis. 18Epidural Injections . 18Facet Joint Injections . 24Sacroiliac Joint Injections . 26Key Question 1a. How does effectiveness vary according to the medication used(corticosteroid, local anesthetic, or both), the dose or frequency of injections, the number oflevels treated, or degree of provider experience? . 27Key Points. 27Detailed Synthesis. 27Epidural Injections For Radiculopathy . 27Epidural Injections For Spinal Stenosis. 29Facet Joint Injections . 30Key Question 1b. How does effectiveness vary according to use of imaging guidance or routeof administration (interlaminar, transforaminal, caudal for epidural injections or intra-articular,extra-articular [peri-capsular], or medial branch for facet injections)? . 30Key Points. 30Detailed Synthesis. 32Epidural Injections for Radiculopathy. 32Epidural Injections For Spinal Stenosis. 35Epidural Injections For Nonradicular Low Back Pain. 35One trial compared transforaminal versus interlaminar epidural corticosteroid injection inpatients with nonradicular low back pain, but only reported results in subgroups stratifiedby presence of imaging findings of herniated disc or spinal stenosis (see KQ 2).128 . 35Facet Joint Injections . 36ix

Key Question 2. In patients with low back pain, what characteristics predict responsiveness toinjection therapies on outcomes related to pain, function, and quality of life? . 37Key Points. 37Detailed Synthesis. 37Epidural Injections . 37Facet Joint Injections . 39Key Question 3. In randomized trials of low back pain injection therapies, how doeseffectiveness vary according to the comparator used (e.g., epidural nonsteroid injection,nonepidural injection, no injection, surgery, or nonsurgical therapies)?. 39Key Points. 39Detailed Synthesis. 40Key Question 3a. How do response rates vary according to the specific comparator evaluated(e.g.

Pain Management Injection Therapies for Low Back Pain Structured Abstract Objectives. Low back pain is common and injections with corticosteroids are a frequently used treatment option. This report reviews the current evidence on effectiveness and harms of epidural, facet joint, and sacroiliac corticosteroid injections for low back pain conditions.File Size: 1MB

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