{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T15:55:24Z","timestamp":1790610924970,"version":"4.1.0"},"reference-count":33,"publisher":"BMJ","license":[{"start":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T00:00:00Z","timestamp":1773360000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100032805","name":"Avanos Medical Inc","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100032805","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Reg Anesth Pain Med"],"accepted":{"date-parts":[[2026,2,17]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Low back pain is a leading cause of disability. Up to 45% of lumbar spine pain may be facetogenic. Both standard radiofrequency ablation (SRFA) and cooled radiofrequency ablation (CRFA) have been deployed to treat facetogenic pain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients with lumbar facetogenic back pain, identified by two positive medial branch blocks (MBBs), were randomized to treatment with CRFA or SRFA. The primary endpoint was the proportion of subjects whose back pain decreased by \u226550% on the Numeric Rating Scale (NRS (usual): patient\u2019s level of pain over the past 7 days) at 6 months, with subjects followed through 12 months. Secondary endpoints included changes in SF-36 (36-Item Short Form Health Survey) Physical Functioning (PF), Oswestry Disability Index (ODI), Global Perceived Effect scale (GPE), and EQ-5D-5L index (EuroQol's Health-Related Quality of Life Score using 5 levels over 5 dimensions).<\/jats:p>\n                    <jats:p>Enrollment (target 188) ended early after 18 months due to funding reallocation and strict Medicare criterion requiring \u226580% pain relief from dual MBBs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>74 patients (37 CRFA, 37 SRFA) were randomized, treated, and included in the intention-to-treat analysis. 61 patients (27 CRFA, 34 SRFA) completed the 6-month primary endpoint visit. Both CRFA and SRFA provided robust, statistically significant and clinically relevant reductions in NRS pain scores from baseline at every time point (p\u22640.0001). CRFA met the predefined non-inferiority criterion relative to SRFA (p=0.0069), with a high proportion of both groups achieving \u226550% pain relief at the primary endpoint\u201474.1% with CRFA and 64.7% with SRFA. Although CRFA showed numerically greater reductions in NRS pain scores from baseline (\u20134.3 vs \u20133.4), both treatments exceeded the minimal clinically important difference threshold. No statistically significant differences in NRS scores were observed between groups at any time point, likely due to the premature termination of the study (only 52% enrolled). Both groups also showed significant and comparable improvements in NRS, EQ-5D-5L, ODI, SF-36 (PF), and GPE at 6 and 12 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Despite the smaller than intended sample size, due to early termination by the sponsor, this study demonstrated that with appropriate patient selection and proper procedural technique, both CRFA and SRFA can relieve chronic facetogenic low back pain, improve disability, function, and quality of life for 6\u201312 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04803149\">NCT04803149<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/rapm-2025-107299","type":"journal-article","created":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T14:55:14Z","timestamp":1773413714000},"page":"rapm-2025-107299","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Prospective, non-inferiority, multicenter, randomized, single-blind clinical trial comparing cooled radiofrequency ablation to standard radiofrequency ablation to manage chronic facetogenic lumbar back pain"],"prefix":"10.1136","clinical-trial-number":[{"clinical-trial-number":"nct04803149","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2147-3523","authenticated-orcid":false,"given":"David A","family":"Provenzano","sequence":"first","affiliation":[{"name":"Pain Diagnostics and Interventional Care, Sewickley, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Li","sequence":"additional","affiliation":[{"name":"Premier Pain Centers, Shrewsbury, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8907-7730","authenticated-orcid":false,"given":"Timothy A","family":"Deer","sequence":"additional","affiliation":[{"name":"The Spine and Nerve Center of the Virginias, Charleston, West Virginia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2718-5837","authenticated-orcid":false,"given":"Leonardo","family":"Kapural","sequence":"additional","affiliation":[{"name":"The Center for Clinical Research, Winston-Salem, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fred K","family":"Khalouf","sequence":"additional","affiliation":[{"name":"University Orthopedics Center, Altoona, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Vetri","sequence":"additional","affiliation":[{"name":"Millennium Pain Center, Bloomington, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith M","family":"Zora","sequence":"additional","affiliation":[{"name":"University Orthopedics Center, State College, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maged N","family":"Guirguis","sequence":"additional","affiliation":[{"name":"Oschner Health System, New Orleans, Louisiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zachary L","family":"McCormick","sequence":"additional","affiliation":[{"name":"University Orthopaedic Center, Salt Lake City, Utah, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,3,13]]},"reference":[{"key":"2026031307550516000_rapm-2025-107299v1.1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.0158"},{"key":"2026031307550516000_rapm-2025-107299v1.2","doi-asserted-by":"crossref","first-page":"902","DOI":"10.1093\/pm\/pnz248","article-title":"The Effectiveness of Radiofrequency Ablation of Medial Branch Nerves for Chronic Lumbar Facet Joint Syndrome in Patients Selected by Guideline-Concordant Dual Comparative Medial Branch Blocks","volume":"21","author":"Conger","year":"2020","journal-title":"Pain Med"},{"key":"2026031307550516000_rapm-2025-107299v1.3","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S323362"},{"key":"2026031307550516000_rapm-2025-107299v1.4","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1177\/204946370800200103","article-title":"Lumbar Zygapophyseal (Facet) Joint Pain","volume":"2","author":"Saravanakumar","year":"2008","journal-title":"Rev Pain"},{"key":"2026031307550516000_rapm-2025-107299v1.5","doi-asserted-by":"crossref","first-page":"1122","DOI":"10.1093\/pm\/pnz349","article-title":"Systematic Review of the Effectiveness of Lumbar Medial Branch Thermal Radiofrequency Neurotomy, Stratified for Diagnostic Methods and Procedural Technique","volume":"21","author":"Schneider","year":"2020","journal-title":"Pain Med"},{"key":"2026031307550516000_rapm-2025-107299v1.6","doi-asserted-by":"crossref","first-page":"1318","DOI":"10.1093\/pm\/pnad107","article-title":"A pragmatic randomized prospective trial of cooled radiofrequency ablation of the medial branch nerves versus facet joint injection of corticosteroid for the treatment of lumbar facet syndrome: 12 month outcomes","volume":"24","author":"McCormick","year":"2023","journal-title":"Pain Med"},{"key":"2026031307550516000_rapm-2025-107299v1.7","doi-asserted-by":"crossref","first-page":"699","DOI":"10.1007\/s11916-024-01241-7","article-title":"Comparison of the Efficacy of Different Radiofrequency Techniques for the Treatment of Lumbar Facet Joint Pain: Combined with Anatomy","volume":"28","author":"Qi","year":"2024","journal-title":"Curr Pain Headache Rep"},{"key":"2026031307550516000_rapm-2025-107299v1.8","article-title":"Assessment of real-world, prospective outcomes in patients treated with cervical radiofrequency ablation for chronic pain (RAPID)","volume":"4","author":"Provenzano","year":"2025","journal-title":"Interv Pain Med"},{"key":"2026031307550516000_rapm-2025-107299v1.9","doi-asserted-by":"publisher","DOI":"10.3344\/kjp.2016.29.1.3"},{"key":"2026031307550516000_rapm-2025-107299v1.10","doi-asserted-by":"crossref","first-page":"E915","DOI":"10.36076\/ppj.20.5.E915","article-title":"Comparisons of Lesion Volumes and Shapes Produced by a Radiofrequency System with a Cooled, a Protruding, or a Monopolar Probe","volume":"20","author":"Cedeno","year":"2017","journal-title":"Pain Physician"},{"key":"2026031307550516000_rapm-2025-107299v1.11","doi-asserted-by":"publisher","DOI":"10.1136\/rapm-2020-101361"},{"key":"2026031307550516000_rapm-2025-107299v1.12","doi-asserted-by":"publisher","DOI":"10.1136\/rapm-2023-104554"},{"key":"2026031307550516000_rapm-2025-107299v1.13","doi-asserted-by":"publisher","DOI":"10.1136\/rapm-2018-000035"},{"key":"2026031307550516000_rapm-2025-107299v1.14","doi-asserted-by":"publisher","DOI":"10.1136\/rapm-2019-101243"},{"key":"2026031307550516000_rapm-2025-107299v1.15","doi-asserted-by":"crossref","first-page":"e5","DOI":"10.1097\/PHM.0000000000000549","article-title":"Water-Cooled Radiofrequency Provides Pain Relief, Decreases Disability, and Improves Quality of Life in Chronic Knee Osteoarthritis","volume":"96","author":"Rojhani","year":"2017","journal-title":"Am J Phys Med Rehabil"},{"key":"2026031307550516000_rapm-2025-107299v1.16","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.7918"},{"key":"2026031307550516000_rapm-2025-107299v1.17","doi-asserted-by":"publisher","DOI":"10.36076\/ppj.2020\/23\/S1"},{"key":"2026031307550516000_rapm-2025-107299v1.18","unstructured":"North American Spine Society . Evidence-based clinical guidelines for multidisciplinary spine care: diagnosis & treatment of low back pain. 2020. Available: https:\/\/www.spine.org\/Portals\/0\/assets\/downloads\/ResearchClinicalCare\/Guidelines\/LowBackPain.pdf [Accessed 4 Jan 2024]."},{"key":"2026031307550516000_rapm-2025-107299v1.19","unstructured":"Centers for Medicare & Medicaid Services . Local coverage determination (LCD): facet joint interventions for pain management (L38841). Available: https:\/\/www.cms.gov\/medicare-coverage-database\/view\/lcd.aspx?LCDId=38841 [Accessed 25 Aug 2025]."},{"key":"2026031307550516000_rapm-2025-107299v1.20","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2007.09.005"},{"key":"2026031307550516000_rapm-2025-107299v1.21","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-004-7713-0"},{"key":"2026031307550516000_rapm-2025-107299v1.22","doi-asserted-by":"crossref","first-page":"90","DOI":"10.1097\/BRS.0b013e31815e3a10","article-title":"Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change","volume":"33","author":"Ostelo","year":"1976","journal-title":"Spine (Phila Pa 1986)"},{"key":"2026031307550516000_rapm-2025-107299v1.23","doi-asserted-by":"publisher","DOI":"10.1016\/j.spinee.2007.11.006"},{"key":"2026031307550516000_rapm-2025-107299v1.24","doi-asserted-by":"crossref","first-page":"1722","DOI":"10.1097\/BRS.0b013e3181a8faf2","article-title":"Patient-level minimal clinically important difference based on clinical judgment and minimally detectable measurement difference: a rationale for the SF-36 physical function scale in the SPORT intervertebral disc herniation cohort","volume":"34","author":"Spratt","year":"1976","journal-title":"Spine (Phila Pa 1986)"},{"key":"2026031307550516000_rapm-2025-107299v1.25","doi-asserted-by":"publisher","DOI":"10.1136\/rapm-2021-103247"},{"key":"2026031307550516000_rapm-2025-107299v1.26","unstructured":"American Academy of Pain Medicine, American Academy of Physical Medicine and Rehabilitation, American College of Radiology . Multisociety statement on effect of radiofrequency denervation on pain intensity among patients with chronic low back pain: the mint randomized clinical trials by juch et al. 2017. Available: https:\/\/cdn.ymaws.com\/www.ipsismed.org\/resource\/resmgr\/advocacy\/2017_11_21_Multisociety_Stat.pdf [Accessed 8 Jan 2024]."},{"key":"2026031307550516000_rapm-2025-107299v1.27","doi-asserted-by":"publisher","DOI":"10.1097\/AAP.0000000000000699"},{"key":"2026031307550516000_rapm-2025-107299v1.28","unstructured":"Bogduk N . Practice guidelines for spinal diagnostic and treatment procedures. International Spine Intervention Society; 2013."},{"key":"2026031307550516000_rapm-2025-107299v1.29","doi-asserted-by":"crossref","first-page":"183","DOI":"10.2147\/JPR.S121897","article-title":"Influence of BMI, gender, and sports on pain decrease and medication usage after facet-medial branch neurotomy or SI joint lateral branch cooled RF-neurotomy in case of low back pain: original research in the Austrian population","volume":"10","author":"Stelzer","year":"2017","journal-title":"J Pain Res"},{"key":"2026031307550516000_rapm-2025-107299v1.30","doi-asserted-by":"publisher","DOI":"10.1016\/jclineuro.2020.105854."},{"key":"2026031307550516000_rapm-2025-107299v1.31","doi-asserted-by":"crossref","first-page":"133","DOI":"10.2217\/pmt-2019-0066","article-title":"A technological overview of cooled radiofrequency ablation and its effectiveness in the management of chronic knee pain","volume":"10","author":"Kapural","year":"2020","journal-title":"Pain Manag"},{"key":"2026031307550516000_rapm-2025-107299v1.32","doi-asserted-by":"crossref","first-page":"2254","DOI":"10.1001\/jama.2017.16386","article-title":"Radiofrequency Denervation for Chronic Low Back Pain","volume":"318","author":"Vorobeychik","year":"2017","journal-title":"JAMA"},{"key":"2026031307550516000_rapm-2025-107299v1.33","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1177\/2049463719840053","article-title":"Best practice in radiofrequency denervation of the lumbar facet joints: a consensus technique","volume":"14","author":"Eldabe","year":"2020","journal-title":"Br J Pain"}],"container-title":["Regional Anesthesia &amp; Pain Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/rapm-2025-107299","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T14:55:19Z","timestamp":1773413719000},"score":1,"resource":{"primary":{"URL":"https:\/\/rapm.bmj.com\/lookup\/doi\/10.1136\/rapm-2025-107299"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,13]]},"references-count":33,"alternative-id":["10.1136\/rapm-2025-107299"],"URL":"https:\/\/doi.org\/10.1136\/rapm-2025-107299","relation":{},"ISSN":["1098-7339","1532-8651"],"issn-type":[{"value":"1098-7339","type":"print"},{"value":"1532-8651","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,13]]}}}