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Lumbosacral radicular painDescriptionStrength of recommendationLevel of evidenceEpidural corticosteroid administration could be used for the treatment of sub-acute lumbosacral radicular pain. Weak moderateDescriptionStrength of recommendationLevel of evidenceEpidural Tumor Necrosis Factor alpha (TNF – α) inhibitors administration could not be used for the management of lumbosacral radicular painWeak againstLowDescriptionStrength of recommendationLevel of evidenceRadiofrequency treatment adjacent to the lumbar ganglion spinale (dorsal root ganglion (DRG)) should not be used for the management of lumbosacral radicular pain.moderate againstmoderateDescriptionStrength of recommendationLevel of evidencePulsed radiofrequency could be considered in patients with chronic lumbosacral radicular pain. ModerateModerateClinical questionWhat is the place of interventional treatments in the management algorithm of lumbosacral radicular pain.Researched treatment optionsFor patients with lumbosacral radicular pain we studied the following treatments:Epidural corticosteroid administrationEpidural transforaminal anti TNF alpha administrationRadiofrequency treatment of the lumbar ggl spinale (DRG)Pulsed radiofrequency treatment of the lumbar ggl spinale (DRG)Any comparators including sham, no treatment or other active treatment techniques were eligible. Inclusion was not restricted based on outcome.Methods For the search strategy we refer to the special section on methods of these guidelines.Interlaminar and transforaminal epidural corticosteroid administration Literature overview:Since the previous guideline, ADDIN EN.CITE <EndNote><Cite><Author>Van Boxem</Author><Year>2010</Year><RecNum>5517</RecNum><DisplayText><style face="superscript">1</style></DisplayText><record><rec-number>5517</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="0">5517</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Van Boxem, K.</author><author>Cheng, J.</author><author>Patijn, J.</author><author>van Kleef, M.</author><author>Lataster, A.</author><author>Mekhail, N.</author><author>Van Zundert, J.</author></authors></contributors><auth-address>Department of Anesthesiology and Pain Management, Maastricht University Medical Centre, Maastricht, The Netherlands.</auth-address><titles><title>11. Lumbosacral radicular pain</title><secondary-title>Pain Pract</secondary-title></titles><periodical><full-title>Pain Pract</full-title></periodical><pages>339-58</pages><volume>10</volume><number>4</number><edition>2010/05/25</edition><dates><year>2010</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1533-2500 (Electronic)&#xD;1530-7085 (Linking)</isbn><accession-num>20492580</accession-num><urls><related-urls><url> [pii]&#xD;10.1111/j.1533-2500.2010.00370.x</electronic-resource-num><language>eng</language></record></Cite></EndNote>1 a number of systematic reviews have been published in relation to epidural injections for lumbosacral radicular pain. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MZXdpczwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+PFJl

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ADDIN EN.CITE.DATA 18. This is a systematic review of guidelines, systematic reviews, RCT’s and large observational cohort studies that report safety. This review found that, overall, epidural steroid injections provide short term but not long-term (over 12 weeks) relief of leg pain and improvement in function when compared with placebo but the clinical benefit is small. Transforaminal corticosteroids are better than placebo in reducing leg pain at long-term follow-up with no improvement in disability, based on very low quality evidence. No single specific injection technique improved back pain. The effect of a corticosteroid injection is not better than local anesthetic alone. There is insufficient evidence to link short-term effectiveness of steroid injections and differing patient characteristicsPinto et al. ADDIN EN.CITE <EndNote><Cite><Author>Pinto</Author><Year>2012</Year><RecNum>10258</RecNum><DisplayText><style face="superscript">4</style></DisplayText><record><rec-number>10258</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1378807164">10258</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pinto, R. Z.</author><author>Maher, C. G.</author><author>Ferreira, M. L.</author><author>Hancock, M.</author><author>Oliveira, V. C.</author><author>McLachlan, A. J.</author><author>Koes, B.</author><author>Ferreira, P. H.</author></authors></contributors><auth-address>The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, Australia. rafaelzambelli@</auth-address><titles><title>Epidural corticosteroid injections in the management of sciatica: a systematic review and meta-analysis</title><secondary-title>Ann Intern Med</secondary-title></titles><periodical><full-title>Ann Intern Med</full-title></periodical><pages>865-77</pages><volume>157</volume><number>12</number><keywords><keyword>Adrenal Cortex Hormones/*administration &amp; dosage/therapeutic use</keyword><keyword>Humans</keyword><keyword>Injections, Epidural</keyword><keyword>Randomized Controlled Trials as Topic</keyword><keyword>Research Design</keyword><keyword>Sciatica/*drug therapy</keyword><keyword>Time Factors</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2012</year><pub-dates><date>Dec 18</date></pub-dates></dates><accession-num>23362516</accession-num><urls><related-urls><url> reviewed only RCTs on the epidural administration of corticosteroids. They included 25 publications on 23 trials. The results were comparable to the results of Shamliyan PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGFtbGl5YW48L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFy

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ADDIN EN.CITE.DATA 18 although the Pinto group rated the quality of the evidence to be high. Conclusion: Short-term effectQuality of the evidence DescriptionModerateThere is evidence of moderate quality that epidural corticosteroid with or without local anesthetic administration reduces modestly leg pain better than placebo during 3 months after the intervention in the treatment of lumbosacral radicular pain refractory to conservative treatment Pinto RZ et al. 2012; Shamliyan et al. 2014Long-term effectQuality of the evidence DescriptionModerate There is evidence of moderate quality that epidural corticosteroid with or without local anesthetic administration does not reduce leg pain better than placebo/ local anesthetic during 12 months after the intervention in the treatment of lumbosacral radicular pain refractory to conservative treatment Shamliyan et al. 2014. Quality of the evidence DescriptionLow There is evidence of moderate quality that epidural corticosteroid with or without local anesthetic administration does not reduce disability better than placebo/ local anesthetic during 12 months after the intervention in the treatment of lumbosacral radicular pain refractory to conservative treatmentShamliyan et al. 2014ConsiderationsEvidence of alternative strategies for lumbosacral radicular painThe initial management of radicular pain is conservative because of the positive spontaneous pain reduction within 3 months in 75% of the patients. ADDIN EN.CITE <EndNote><Cite><Author>Peul</Author><Year>2008</Year><RecNum>4016</RecNum><DisplayText><style face="superscript">19</style></DisplayText><record><rec-number>4016</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="0">4016</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Peul, W. C.</author><author>Brand, R.</author><author>Thomeer, R. T.</author><author>Koes, B. W.</author></authors></contributors><auth-address>Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands. w.c.peul@lumc.nl</auth-address><titles><title>Influence of gender and other prognostic factors on outcome of sciatica</title><secondary-title>Pain</secondary-title></titles><periodical><full-title>Pain</full-title></periodical><pages>180-91</pages><volume>138</volume><number>1</number><edition>2008/02/05</edition><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Netherlands/epidemiology</keyword><keyword>Outcome Assessment (Health Care)/*methods</keyword><keyword>Prevalence</keyword><keyword>Prognosis</keyword><keyword>Risk Assessment/*methods</keyword><keyword>Risk Factors</keyword><keyword>Sciatica/*diagnosis/*epidemiology</keyword><keyword>Sex Factors</keyword></keywords><dates><year>2008</year><pub-dates><date>Aug 15</date></pub-dates></dates><isbn>1872-6623 (Electronic)</isbn><accession-num>18241991</accession-num><urls><related-urls><url>(07)00747-6 [pii]&#xD;10.1016/j.pain.2007.12.014</electronic-resource-num><language>eng</language></record></Cite></EndNote>19 The evidence of bedrest, activation, physical therapy, exercises or medication (acetaminophen/paracetamol, NSAID, systemic glucocorticoids, anti epileptics, antidepressants, muscle relaxants, opioids) is limited or insufficient. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Hb2xkYmVyZzwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+

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ADDIN EN.CITE.DATA 20-22 Position of epidural corticosteroids in treatment algorithmIf after several weeks of conservative treatment patients still report high pain scores, two strategies are valid : immediately proceed to surgery, or try to “bridge” the first 3 months until the chance of spontaneous resolution of symptoms becomes very small. The main indications for epidural corticosteroids are therefore : persistent pain despite conservative management during the first weeks to months, when there is no surgical indication or patient refusal of surgery. The administration of epidural corticosteroids is cost-effectivePEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TcGlqa2VyLUh1aWdlczwvQXV0aG9yPjxZZWFyPjIwMTQ8

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ADDIN EN.CITE.DATA 23 , making a “stepped-up approach” with epidural steroid injections before proceeding to surgery the most cost-effective in a health economic model.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GaXR6c2ltbW9uczwvQXV0aG9yPjxZZWFyPjIwMTQ8L1ll

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ADDIN EN.CITE.DATA 24 The majority of the studies and reviews make no difference between (sub)-acute and chronic lumbosacral radicular pain, therefore the restriction to reserve epidural injection for sub-acute lumbosacral radicular pain cannot be supported by evidence from clinical trials. The short duration of action and limited clinical relevant improvement, allows patients in the sub-acute phase to exercise and thus stimulates the natural recovery.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj52YW4gSGVsdm9pcnQ8L0F1dGhvcj48WWVhcj4yMDE0PC9Z

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ADDIN EN.CITE.DATA 25 For patients with chronic lumbosacral radicular pain the treatment would have to be frequently repeated, thus increasing the risk for side effects and complication. Therefore other treatment options are preferred in the chronic phase.In clinical trials corticosteroids are often mixed with local anesthetic, making it difficult to judge the clinical relevance of adding local anesthetic to the injectate. Risk of contamination and serious infectionsThe “Division of Pharmacovigilance II” of the FDA evaluated the incidence of serious neurological complications after the administration of epidural corticosteroids, through the “FDA Adverse Event Reporting System” (FAERS) database. A search included articles from 1 January 1965 until 04/23/2014 regarding arachnoiditis, and from 11/1/1997 tot 04/23/2014 for serious complications of the nervous system “nervous system disorder”. This resulted in 131 cases in total (18 published case reports included), of which 41 cases of arachnoiditis and 90 serious cases of “nervous system disorder”. ADDIN EN.CITE <EndNote><Cite><Author>FDA</Author><Year>2014</Year><RecNum>11544</RecNum><DisplayText><style face="superscript">26</style></DisplayText><record><rec-number>11544</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1442409418">11544</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>FDA ,</author></authors><secondary-authors><author>Anesthetic and Analgesic Drug Products Advisory Committee,</author></secondary-authors></contributors><titles><title>Epidural Steroid Injections (ESI) and the Risk of Serious Neurologic Adverse Reactions</title><secondary-title>Anesthetic and Analgesic Drug Products Advisory Committee: Briefing document</secondary-title></titles><dates><year>2014</year><pub-dates><date>November 24-25</date></pub-dates></dates><urls><related-urls><url>AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ AnastheticAndAnalegicDrugProductsAdvisory Committee/ucm422691.htm </url></related-urls></urls></record></Cite></EndNote>26 Cases of fungal contamination were not included. An exact incidence can not be determined, for this demands an extensive population based study PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SYWNvb3NpbjwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+

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ADDIN EN.CITE.DATA 27, but only in the U.S. there are estimations that up to 9 miljons epidural corticosteroid infiltrations are done on a yearly base. It is clearly stated that major complications are rare , making it impossible to determine the exact incidence of complications. ADDIN EN.CITE <EndNote><Cite><Author>FDA</Author><Year>2014</Year><RecNum>11544</RecNum><DisplayText><style face="superscript">26</style></DisplayText><record><rec-number>11544</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1442409418">11544</key></foreign-keys><ref-type name="Report">27</ref-type><contributors><authors><author>FDA ,</author></authors><secondary-authors><author>Anesthetic and Analgesic Drug Products Advisory Committee,</author></secondary-authors></contributors><titles><title>Epidural Steroid Injections (ESI) and the Risk of Serious Neurologic Adverse Reactions</title><secondary-title>Anesthetic and Analgesic Drug Products Advisory Committee: Briefing document</secondary-title></titles><dates><year>2014</year><pub-dates><date>November 24-25</date></pub-dates></dates><urls><related-urls><url>AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ AnastheticAndAnalegicDrugProductsAdvisory Committee/ucm422691.htm </url></related-urls></urls></record></Cite></EndNote>26 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SYWNvb3NpbjwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+

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ADDIN EN.CITE.DATA 27 ADDIN EN.CITE <EndNote><Cite><Author>McGrath</Author><Year>2011</Year><RecNum>11450</RecNum><DisplayText><style face="superscript">28</style></DisplayText><record><rec-number>11450</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1436793130">11450</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>McGrath, J. M.</author><author>Schaefer, M. P.</author><author>Malkamaki, D. M.</author></authors></contributors><auth-address>MetroHealth Campus of Case Western Reserve University School of Medicine, Cleveland Heights, Ohio , USA.</auth-address><titles><title>Incidence and characteristics of complications from epidural steroid injections</title><secondary-title>Pain Med</secondary-title></titles><periodical><full-title>Pain Med</full-title></periodical><pages>726-31</pages><volume>12</volume><number>5</number><keywords><keyword>Back Pain/drug therapy</keyword><keyword>Cervical Vertebrae</keyword><keyword>Humans</keyword><keyword>Injections, Epidural/*adverse effects</keyword><keyword>Lumbar Vertebrae</keyword><keyword>Radiculopathy/drug therapy</keyword><keyword>Retrospective Studies</keyword><keyword>Steroids/*administration &amp; dosage/*adverse effects/therapeutic use</keyword></keywords><dates><year>2011</year><pub-dates><date>May</date></pub-dates></dates><isbn>1526-4637 (Electronic)&#xD;1526-2375 (Linking)</isbn><accession-num>21392252</accession-num><urls><related-urls><url> In summary, there seems to be a limited clinical effect in the short-term for epidural corticosteroid injections for the treatment of (sub)-acute lumbosacral radicular pain. Severe side effects have rarely been reported.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SYWNvb3NpbjwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+

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ADDIN EN.CITE.DATA 27 This treatment is an “off label” use of corticosteroids, therefore written informed consent is mandatory. The use of image guidance is obligatory for safety reasons. Epidural corticosteroid administration is a low cost treatment. The three administration routes have been compared by Cohen. ADDIN EN.CITE <EndNote><Cite><Author>Cohen</Author><Year>2013</Year><RecNum>10400</RecNum><DisplayText><style face="superscript">29</style></DisplayText><record><rec-number>10400</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1387205059">10400</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Cohen, S. P.</author><author>Bicket, M. C.</author><author>Jamison, D.</author><author>Wilkinson, I.</author><author>Rathmell, J. P.</author></authors></contributors><auth-address>Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA. scohen40@jhmi.edu</auth-address><titles><title>Epidural steroids: a comprehensive, evidence-based review</title><secondary-title>Reg Anesth Pain Med</secondary-title></titles><periodical><full-title>Reg Anesth Pain Med</full-title></periodical><pages>175-200</pages><volume>38</volume><number>3</number><keywords><keyword>Adrenal Cortex Hormones/*administration &amp; dosage/adverse effects</keyword><keyword>Clinical Trials as Topic</keyword><keyword>Cost-Benefit Analysis</keyword><keyword>Health Services/utilization</keyword><keyword>Humans</keyword><keyword>Injections, Epidural/adverse effects</keyword><keyword>Low Back Pain/drug therapy</keyword><keyword>Neck Pain/drug therapy</keyword><keyword>Pain/*drug therapy</keyword></keywords><dates><year>2013</year><pub-dates><date>May-Jun</date></pub-dates></dates><accession-num>23598728</accession-num><urls><related-urls><url> The transforaminal route was shown to be better than the caudal route, which in turn was better than the interlaminar route. Therefore the transforaminal route is preferred. The limited clinical effect justifies downgrading the recommendation.RecommendationsDescriptionStrength of recommendationLevel of evidenceEpidural corticosteroid administration could be used for the treatment of sub-acute lumbosacral radicular pain.Weak moderateTransforaminal epidural tumor necrosis factor alpha (TNF- α) inhibitors administrationLiterature overview: The epidural administration of tumour necrosis factor alpha (TNF-α) inhibitors was not discussed in the previous guideline.A systematic review PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYW5nPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA 30 including randomised and cross-over controlled trials, non-randomised concurrent trials, before-after controlled trials, and case-control studies was found.In total 11 studies were assessed in this review.TNF-α inhibitors did not relieve lower back and leg pain significantly, at short term, medium-term and long-term follow-up (p > 0.05), in comparison to the control condition (placebo or steroid).TNF-α inhibitors did not increase the proportion of patients who felt overall satisfaction (global perceived effect) or were able to return to work at short term, medium-term and long-term follow-up (p > 0.05).TNF- α inhibitors were found to reduce the risk of discectomy or radicular block (combined endpoint; Risk Ratio (RR) = 0.51, 95% CI 0.26 to 1.00, 3 studies) at medium-term follow-up, but no effect was seen at short-term (RR = 0.64, 95% CI 0.17 to 2.40, 4 studies) and long-term follow-ups (RR = 0.64, 95% CI 0.40 to 1.03,4 studies).The review has several weaknesses and a high risk of bias. Conclusions are based on small numbers of patients and diverse studies and should therefore be treated with some caution.ConclusionsQuality of the evidence DescriptionLow There is evidence of low quality that epidural injection of Tumor Necrosis Factor alpha (TNF- α) inhibitors does not reduce low back pain better than placebo/corticosteroids in patients with lumbosacral radicular painWang YF et al. 2014Quality of the evidence DescriptionLow There is evidence of low quality that epidural injection of Tumor Necrosis Factor alpha (TNF- α) inhibitors does not reduce leg pain better than placebo/corticosteroids in patients with lumbosacral radicular pain at the short, medium, and long-term follow-up. Wang YF et al. 2014Quality of the evidence DescriptionLow There is evidence of low quality that epidural injection of Tumor Necrosis Factor alpha (TNF- α) inhibitors does not improve disability better than placebo/corticosteroids in patients with lumbosacral radicular pain. at the short, medium, and long-term follow-up. Wang YF et al. 2014Considerations:There seems to be limited clinical relevant effect in the short term for epidural administration of TNF- α inhibitors in patients with lumbosacral radicular pain.Given the limited clinical value, this should be balanced against possible side effects. Serious adverse events have been reported. In a cohort study of 71 patients who were followed over a period of 7 years, 13 serious side effects were reported (respiratory complications and malignancy)PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IZWxkbWFubjwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+

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ADDIN EN.CITE.DATA 32 Recommendations:DescriptionStrength of recommendationLevel of evidenceEpidural Tumor Necrosis Factor alpha (TNF – α) inhibitors administration could not be used for the management of lumbosacral radicular painWeak againstLowRadiofrequency treatment adjacent to the lumbar ganglion spinale (DRG) Literature overview:The negative recommendation formulated in the previous guideline ADDIN EN.CITE <EndNote><Cite><Author>Van Boxem</Author><Year>2010</Year><RecNum>5517</RecNum><DisplayText><style face="superscript">1</style></DisplayText><record><rec-number>5517</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="0">5517</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Van Boxem, K.</author><author>Cheng, J.</author><author>Patijn, J.</author><author>van Kleef, M.</author><author>Lataster, A.</author><author>Mekhail, N.</author><author>Van Zundert, J.</author></authors></contributors><auth-address>Department of Anesthesiology and Pain Management, Maastricht University Medical Centre, Maastricht, The Netherlands.</auth-address><titles><title>11. Lumbosacral radicular pain</title><secondary-title>Pain Pract</secondary-title></titles><periodical><full-title>Pain Pract</full-title></periodical><pages>339-58</pages><volume>10</volume><number>4</number><edition>2010/05/25</edition><dates><year>2010</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1533-2500 (Electronic)&#xD;1530-7085 (Linking)</isbn><accession-num>20492580</accession-num><urls><related-urls><url> [pii]&#xD;10.1111/j.1533-2500.2010.00370.x</electronic-resource-num><language>eng</language></record></Cite></EndNote>1 was based on the RCT on 83 patients comparing RF treatment with a sham intervention. At 3 months follow-up no differences were seen between the two groups. ADDIN EN.CITE <EndNote><Cite><Author>Geurts</Author><Year>2003</Year><RecNum>1661</RecNum><DisplayText><style face="superscript">33</style></DisplayText><record><rec-number>1661</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="0">1661</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Geurts, J. W.</author><author>van Wijk, R. M.</author><author>Wynne, H. J.</author><author>Hammink, E.</author><author>Buskens, E.</author><author>Lousberg, R.</author><author>Knape, J. T.</author><author>Groen, G. J.</author></authors></contributors><auth-address>Division of Perioperative Medicine, Anaesthesiology, and Pain Management, University Medical Centre Utrecht, Utrecht, Netherlands. anesthesiologen.arnhem@planet.nl</auth-address><titles><title>Radiofrequency lesioning of dorsal root ganglia for chronic lumbosacral radicular pain: a randomised, double-blind, controlled trial</title><secondary-title>Lancet</secondary-title></titles><periodical><full-title>Lancet</full-title></periodical><pages>21-6</pages><volume>361</volume><number>9351</number><keywords><keyword>*Catheter Ablation</keyword><keyword>Double-Blind Method</keyword><keyword>Female</keyword><keyword>Ganglia, Spinal/*surgery</keyword><keyword>Humans</keyword><keyword>Lumbosacral Region</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Netherlands</keyword><keyword>Pain/*etiology/therapy</keyword><keyword>Pain Measurement</keyword><keyword>Radiculopathy/*surgery</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2003</year><pub-dates><date>Jan 4</date></pub-dates></dates><accession-num>12517462</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>33Evidence on the effectiveness of conventional radiofrequency was taken from a systematic review, that did not identify additional studies beyond those in the previous guidance. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Qb3BlPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA 34 Our search for randomized trials postdating the review did not identify any further trials. We consider that the evidence has not changed since the publication of the previous guideline. ADDIN EN.CITE <EndNote><Cite><Author>van Zundert</Author><Year>2012</Year><RecNum>24</RecNum><DisplayText><style face="superscript">35</style></DisplayText><record><rec-number>24</rec-number><foreign-keys><key app="EN" db-id="w09dw9et8sfxe4ev094vsttywzet9p5aaxv2" timestamp="1400231138">24</key></foreign-keys><ref-type name="Edited Book">28</ref-type><contributors><authors><author>van Zundert, J.</author><author>Patijn, J.</author><author>Hartrick, C.T.</author><author>Lataster, A.</author><author>Huygen, F.J.P.M.</author><author>Mekhail, N.</author><author>van Kleef, M.</author></authors></contributors><titles><title>Evidence-based interventional pain medicine: according to clinical diagnoses </title></titles><dates><year>2012</year></dates><pub-location>Chichester</pub-location><publisher>Wiley-Blackwell</publisher><urls></urls><custom2>DAF</custom2><custom4>SBD. Added 16.5.14</custom4><custom6> </custom6></record></Cite></EndNote>35 ConclusionQuality of the evidence DescriptionModerateThere is evidence of moderate quality that radiofrequency treatment adjacent to the lumbar ganglion spinale (dorsal root ganglion (DRG)) is not better than sham intervention. RecommendationDescriptionStrength of recommendationLevel of evidenceRadiofrequency treatment adjacent to the lumbar ganglion spinale (dorsal root ganglion (DRG)) should not be used for the management of lumbosacral radicular pain.moderate againstmoderatePulsed radiofrequency treatment adjacent to the lumbar ganglion spinale (DRG)Literature overviewThe recommendations that PRF treatment adjacent to the lumbar ganglion spinale (DRG) can be considered, preferable study related, in the previous guideline were based on two retrospective studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UZWl4ZWlyYTwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+

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ADDIN EN.CITE.DATA 38 A systematic review ADDIN EN.CITE <EndNote><Cite><Author>Pope</Author><Year>2013</Year><RecNum>10748</RecNum><DisplayText><style face="superscript">39</style></DisplayText><record><rec-number>10748</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1393592108">10748</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pope, J. E.</author><author>Deer, T. R.</author><author>Kramer, J.</author></authors></contributors><auth-address>The Center for Pain Relief, Charleston, West Virginia.</auth-address><titles><title>A Systematic Review: Current and Future Directions of Dorsal Root Ganglion Therapeutics to Treat Chronic Pain</title><secondary-title>Pain Med</secondary-title></titles><periodical><full-title>Pain Med</full-title></periodical><dates><year>2013</year><pub-dates><date>Jun 26</date></pub-dates></dates><accession-num>23802747</accession-num><urls><related-urls><url> confirmed that up to December 2012 only observational studies were available to assess the efficacy of pulsed radiofrequency of the dorsal root ganglion for the treatment of lumbosacral radicular pain. It identified two additional retrospective studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WYW4gQm94ZW08L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFy

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ADDIN EN.CITE.DATA 40, 41 to supplement the previous guideline. ADDIN EN.CITE <EndNote><Cite><Author>Van Boxem</Author><Year>2010</Year><RecNum>5517</RecNum><DisplayText><style face="superscript">1</style></DisplayText><record><rec-number>5517</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="0">5517</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Van Boxem, K.</author><author>Cheng, J.</author><author>Patijn, J.</author><author>van Kleef, M.</author><author>Lataster, A.</author><author>Mekhail, N.</author><author>Van Zundert, J.</author></authors></contributors><auth-address>Department of Anesthesiology and Pain Management, Maastricht University Medical Centre, Maastricht, The Netherlands.</auth-address><titles><title>11. Lumbosacral radicular pain</title><secondary-title>Pain Pract</secondary-title></titles><periodical><full-title>Pain Pract</full-title></periodical><pages>339-58</pages><volume>10</volume><number>4</number><edition>2010/05/25</edition><dates><year>2010</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1533-2500 (Electronic)&#xD;1530-7085 (Linking)</isbn><accession-num>20492580</accession-num><urls><related-urls><url> [pii]&#xD;10.1111/j.1533-2500.2010.00370.x</electronic-resource-num><language>eng</language></record></Cite></EndNote>1 An additional search for randomized controlled trials published subsequently revealed two RCTs, one of which was published in Japanese and not available as a full text paper thus preventing to draw conclusions on the effectiveness of PRF from this paper. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GdWppaTwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+PFJl

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ADDIN EN.CITE.DATA 42 The other was a pilot study which main aim was to consider the feasibility of assessing the efficacy of PRF-DRG when compared to placebo. ADDIN EN.CITE <EndNote><Cite><Author>Shanthanna</Author><Year>2014</Year><RecNum>10424</RecNum><DisplayText><style face="superscript">43</style></DisplayText><record><rec-number>10424</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1390302591">10424</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Shanthanna, H</author><author>Chan, P</author><author>McChesney, J</author><author>Thabane, L</author><author>Paul, J</author></authors></contributors><titles><title>Pulsed radiofrequency treatment of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain: a randomized, placebo-controlled pilot study</title><secondary-title>Journal of Pain Research</secondary-title><short-title>lumbar radicular</short-title></titles><periodical><full-title>Journal of Pain Research</full-title></periodical><pages>47-55</pages><volume>7</volume><number>1</number><dates><year>2014</year></dates><orig-pub>RCT</orig-pub><label>RF 2014</label><work-type>PRF</work-type><urls></urls></record></Cite></EndNote>43 This was a well-conducted pilot RCT. However the focus of the trial was on recruitment rate and completeness of follow-up. ADDIN EN.CITE <EndNote><Cite><Author>Shanthanna</Author><Year>2014</Year><RecNum>10424</RecNum><DisplayText><style face="superscript">43</style></DisplayText><record><rec-number>10424</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1390302591">10424</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Shanthanna, H</author><author>Chan, P</author><author>McChesney, J</author><author>Thabane, L</author><author>Paul, J</author></authors></contributors><titles><title>Pulsed radiofrequency treatment of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain: a randomized, placebo-controlled pilot study</title><secondary-title>Journal of Pain Research</secondary-title><short-title>lumbar radicular</short-title></titles><periodical><full-title>Journal of Pain Research</full-title></periodical><pages>47-55</pages><volume>7</volume><number>1</number><dates><year>2014</year></dates><orig-pub>RCT</orig-pub><label>RF 2014</label><work-type>PRF</work-type><urls></urls></record></Cite></EndNote>43 The trial was not powered to detect differences in clinical effectiveness as calculation of power needed for a larger efficacy trial was part of the aim of this pilot trial. ADDIN EN.CITE <EndNote><Cite><Author>Shanthanna</Author><Year>2014</Year><RecNum>10424</RecNum><DisplayText><style face="superscript">43</style></DisplayText><record><rec-number>10424</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1390302591">10424</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Shanthanna, H</author><author>Chan, P</author><author>McChesney, J</author><author>Thabane, L</author><author>Paul, J</author></authors></contributors><titles><title>Pulsed radiofrequency treatment of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain: a randomized, placebo-controlled pilot study</title><secondary-title>Journal of Pain Research</secondary-title><short-title>lumbar radicular</short-title></titles><periodical><full-title>Journal of Pain Research</full-title></periodical><pages>47-55</pages><volume>7</volume><number>1</number><dates><year>2014</year></dates><orig-pub>RCT</orig-pub><label>RF 2014</label><work-type>PRF</work-type><urls></urls></record></Cite></EndNote>43 Neither was the trial designed to assess long-term effectiveness of treatment (participants were followed up to 3 months). ADDIN EN.CITE <EndNote><Cite><Author>Shanthanna</Author><Year>2014</Year><RecNum>10424</RecNum><DisplayText><style face="superscript">43</style></DisplayText><record><rec-number>10424</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1390302591">10424</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Shanthanna, H</author><author>Chan, P</author><author>McChesney, J</author><author>Thabane, L</author><author>Paul, J</author></authors></contributors><titles><title>Pulsed radiofrequency treatment of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain: a randomized, placebo-controlled pilot study</title><secondary-title>Journal of Pain Research</secondary-title><short-title>lumbar radicular</short-title></titles><periodical><full-title>Journal of Pain Research</full-title></periodical><pages>47-55</pages><volume>7</volume><number>1</number><dates><year>2014</year></dates><orig-pub>RCT</orig-pub><label>RF 2014</label><work-type>PRF</work-type><urls></urls></record></Cite></EndNote>43 The conclusions of this pilot trial were that the relative benefit of PRF was small which might create difficulties for the recruitment of a sufficient number of patients for a larger trial. ADDIN EN.CITE <EndNote><Cite><Author>Shanthanna</Author><Year>2014</Year><RecNum>10424</RecNum><DisplayText><style face="superscript">43</style></DisplayText><record><rec-number>10424</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1390302591">10424</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Shanthanna, H</author><author>Chan, P</author><author>McChesney, J</author><author>Thabane, L</author><author>Paul, J</author></authors></contributors><titles><title>Pulsed radiofrequency treatment of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain: a randomized, placebo-controlled pilot study</title><secondary-title>Journal of Pain Research</secondary-title><short-title>lumbar radicular</short-title></titles><periodical><full-title>Journal of Pain Research</full-title></periodical><pages>47-55</pages><volume>7</volume><number>1</number><dates><year>2014</year></dates><orig-pub>RCT</orig-pub><label>RF 2014</label><work-type>PRF</work-type><urls></urls></record></Cite></EndNote>43 The authors of the review advised that, until clear parameters for the application of PRF are established, clinicians may have to rely on individual judgement. ADDIN EN.CITE <EndNote><Cite><Author>Shanthanna</Author><Year>2014</Year><RecNum>10424</RecNum><DisplayText><style face="superscript">43</style></DisplayText><record><rec-number>10424</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1390302591">10424</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Shanthanna, H</author><author>Chan, P</author><author>McChesney, J</author><author>Thabane, L</author><author>Paul, J</author></authors></contributors><titles><title>Pulsed radiofrequency treatment of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain: a randomized, placebo-controlled pilot study</title><secondary-title>Journal of Pain Research</secondary-title><short-title>lumbar radicular</short-title></titles><periodical><full-title>Journal of Pain Research</full-title></periodical><pages>47-55</pages><volume>7</volume><number>1</number><dates><year>2014</year></dates><orig-pub>RCT</orig-pub><label>RF 2014</label><work-type>PRF</work-type><urls></urls></record></Cite></EndNote>43 We agree with this conclusion and would not consider the evidence to have advanced beyond the rating of the previous guideline. ADDIN EN.CITE <EndNote><Cite><Author>Van Boxem</Author><Year>2010</Year><RecNum>5517</RecNum><DisplayText><style face="superscript">1</style></DisplayText><record><rec-number>5517</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="0">5517</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Van Boxem, K.</author><author>Cheng, J.</author><author>Patijn, J.</author><author>van Kleef, M.</author><author>Lataster, A.</author><author>Mekhail, N.</author><author>Van Zundert, J.</author></authors></contributors><auth-address>Department of Anesthesiology and Pain Management, Maastricht University Medical Centre, Maastricht, The Netherlands.</auth-address><titles><title>11. Lumbosacral radicular pain</title><secondary-title>Pain Pract</secondary-title></titles><periodical><full-title>Pain Pract</full-title></periodical><pages>339-58</pages><volume>10</volume><number>4</number><edition>2010/05/25</edition><dates><year>2010</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1533-2500 (Electronic)&#xD;1530-7085 (Linking)</isbn><accession-num>20492580</accession-num><urls><related-urls><url> [pii]&#xD;10.1111/j.1533-2500.2010.00370.x</electronic-resource-num><language>eng</language></record></Cite></EndNote>1 The review of Pope ADDIN EN.CITE <EndNote><Cite><Author>Pope</Author><Year>2013</Year><RecNum>10748</RecNum><DisplayText><style face="superscript">39</style></DisplayText><record><rec-number>10748</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1393592108">10748</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pope, J. E.</author><author>Deer, T. R.</author><author>Kramer, J.</author></authors></contributors><auth-address>The Center for Pain Relief, Charleston, West Virginia.</auth-address><titles><title>A Systematic Review: Current and Future Directions of Dorsal Root Ganglion Therapeutics to Treat Chronic Pain</title><secondary-title>Pain Med</secondary-title></titles><periodical><full-title>Pain Med</full-title></periodical><dates><year>2013</year><pub-dates><date>Jun 26</date></pub-dates></dates><accession-num>23802747</accession-num><urls><related-urls><url> has several methodological weaknesses and a high risk of bias.Conclusion:Quality of the evidence DescriptionModerate There is evidence of moderate quality that pulsed radiofrequency treatment adjacent to the lumbar ganglion spinale (dorsal root ganglion (DRG)) reduces pain in patients with lumbosacral radicular pain for up to 6 months. Van Boxem K et al. 2010; Pope et al. 2013; Van Boxem K et al. 2011; Nagda et al. 2011; Fuji H et al. 2012; Shanthanna H et al. 2014ConsiderationsPRF adjacent to the lumbar DRG may have a clinical relevant effect on lumbosacral radicular painNo complications have been reportedA prospective cohort study to evaluate the effect of PRF adjacent to the lumbar DRG on pain and quality of life included 65 patients with unilateral and monosegmental radiating pain At 6 months follow-up the intention-to-treat analysis showed clinical success in 55.4% of the patients. The reduction in NRS and ODI was statistical significant compared to baseline. Also the DN4 showed a significant improvement, indicating that the neuropathic component of the radicular pain is reduced after PRF treatment . The RAND-36 showed significant improvement in the physical component scale at 3 and 6 months. The information of this study was used to assess the non-psychological parameters that may be predictive for the treatment outcome. A positive diagnostic block of the corresponding nerve root was predictive for treatment success. Clinical success at 6 months is better in patients older than 55 years. High disability is a negative predictor for successful outcome of PRF adjacent to the DRG. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WYW4gQm94ZW08L0F1dGhvcj48WWVhcj4yMDE2PC9ZZWFy

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ADDIN EN.CITE.DATA 46 In another prospective RCT 50 patients with lumbosacral radicular pain refractory to transforaminal epidural steroids received conventional monopolar or bipolar (2 cannulae tips) PRF adjacent to the lumbar ganglion spinale (DRG). In the bipolar group the pretreatment pain intensity (NRS 0-10) was 5.1±0.8. At 1 month, the mean NRS was 2.5±1.5, at 2 months, 2.6±1.6, and at 3 months, 2.6±1.7. In the monopolar PRF group, the mean NRS decreased from 4.6±0.8 pretreatment to 3.0±1.5 at 1 month, 3.0±1.5 at 2 months, and 3.0±1.5 at 3 months. Three months after treatment, 76% in the bipolar versus 48% in the monopolar PRF group reported successful pain relief (≥ 50% pain reduction). ADDIN EN.CITE <EndNote><Cite><Author>Chang</Author><Year>2017</Year><RecNum>12396</RecNum><DisplayText><style face="superscript">47</style></DisplayText><record><rec-number>12396</rec-number><foreign-keys><key app="EN" db-id="ver2pweeyf0df2ervxhv0xs1v2z9x2zx52sr" timestamp="1493878946">12396</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Chang, M. C.</author><author>Cho, Y. W.</author><author>Ahn, S. H.</author></authors></contributors><auth-address>aDepartment of Physical Medicine and Rehabilitation, College of Medicine, Yeungnam University bDr Ahn&apos;s Spine &amp; Pain Clinic, and Dr Ahn&apos;s Spine and Pain Institute, Taegu, Republic of Korea.</auth-address><titles><title>Comparison between bipolar pulsed radiofrequency and monopolar pulsed radiofrequency in chronic lumbosacral radicular pain: A randomized controlled trial</title><secondary-title>Medicine (Baltimore)</secondary-title><short-title>Lumbosacral radicular pain</short-title></titles><periodical><full-title>Medicine (Baltimore)</full-title></periodical><pages>e6236</pages><volume>96</volume><number>9</number><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Chronic Pain/*therapy</keyword><keyword>Female</keyword><keyword>Ganglia, Spinal</keyword><keyword>Humans</keyword><keyword>Low Back Pain/*therapy</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>*Pulsed Radiofrequency Treatment</keyword></keywords><dates><year>2017</year><pub-dates><date>Mar</date></pub-dates></dates><orig-pub>RCT</orig-pub><isbn>1536-5964 (Electronic)&#xD;0025-7974 (Linking)</isbn><accession-num>28248888</accession-num><work-type>PRF</work-type><urls><related-urls><url>. 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