Comparison of the Efficacy Between Intradiscal Gelified Ethanol (Discogel) Injection and Intradiscal Combination of Pulsed Radiofrequency and Gelified Ethanol (Discogel) Injection for Chronic Discogenic Low Back Pain Treatment. A Randomized Double-Blind Clinical Study

Abstract Objective The aim of the present study was to compare two new techniques, intradiscal gelified ethanol injection (Discogel) and the combination of intradiscal pulsed radiofrequency and gelified ethanol injection (PRF+Discogel), regarding their efficacy in discogenic low back pain treatment....

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Veröffentlicht in:Pain medicine (Malden, Mass.) Mass.), 2020-11, Vol.21 (11), p.2713-2718
Hauptverfasser: Papadopoulos, Dimitrios, Batistaki, Chrysanthi, Kostopanagiotou, Georgia
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Batistaki, Chrysanthi
Kostopanagiotou, Georgia
description Abstract Objective The aim of the present study was to compare two new techniques, intradiscal gelified ethanol injection (Discogel) and the combination of intradiscal pulsed radiofrequency and gelified ethanol injection (PRF+Discogel), regarding their efficacy in discogenic low back pain treatment. Design Randomized, double-blind, clinical study. Methods The final sample was randomized into group A (N = 18, D) and group B (N = 18, PRF+D). During the procedure, four patients from group B were excluded from the study. Groups A and B were assessed regarding the pain score (VAS 0–10), before the interventional procedures, and one, three, six, and 12 months after. Secondary objectives of the study were to compare the two groups regarding the results of the Roland Morris Disability Questionnaire, Lanss score, and quality of life score (EQ-5D). Results There was no significant evidence for an overall difference in pain score between the two groups (analysis of variance, F = 3.24, df = 1, P = 0.084), except for the sixth and 12th months, when group B presented a statistically important difference compared with group A (Wilcoxon test). Group B appeared to be more effective, with a statistically significant difference, compared with group A regarding the secondary objectives of the study. Conclusions After rigorous and comprehensive assessment by an independent observer, both Discogel alone and Discogel in combination with pulsed radiofrequency produced tangible improvements in pain, function, quality of life, and consumption of analgesics, which were sustained at 12 months.
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A Randomized Double-Blind Clinical Study</title><source>MEDLINE</source><source>Oxford University Press Journals All Titles (1996-Current)</source><source>Web of Science - Science Citation Index Expanded - 2020&lt;img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" /&gt;</source><source>Alma/SFX Local Collection</source><creator>Papadopoulos, Dimitrios ; Batistaki, Chrysanthi ; Kostopanagiotou, Georgia</creator><creatorcontrib>Papadopoulos, Dimitrios ; Batistaki, Chrysanthi ; Kostopanagiotou, Georgia</creatorcontrib><description>Abstract Objective The aim of the present study was to compare two new techniques, intradiscal gelified ethanol injection (Discogel) and the combination of intradiscal pulsed radiofrequency and gelified ethanol injection (PRF+Discogel), regarding their efficacy in discogenic low back pain treatment. Design Randomized, double-blind, clinical study. Methods The final sample was randomized into group A (N = 18, D) and group B (N = 18, PRF+D). During the procedure, four patients from group B were excluded from the study. Groups A and B were assessed regarding the pain score (VAS 0–10), before the interventional procedures, and one, three, six, and 12 months after. Secondary objectives of the study were to compare the two groups regarding the results of the Roland Morris Disability Questionnaire, Lanss score, and quality of life score (EQ-5D). Results There was no significant evidence for an overall difference in pain score between the two groups (analysis of variance, F = 3.24, df = 1, P = 0.084), except for the sixth and 12th months, when group B presented a statistically important difference compared with group A (Wilcoxon test). Group B appeared to be more effective, with a statistically significant difference, compared with group A regarding the secondary objectives of the study. Conclusions After rigorous and comprehensive assessment by an independent observer, both Discogel alone and Discogel in combination with pulsed radiofrequency produced tangible improvements in pain, function, quality of life, and consumption of analgesics, which were sustained at 12 months.</description><identifier>ISSN: 1526-2375</identifier><identifier>EISSN: 1526-4637</identifier><identifier>DOI: 10.1093/pm/pnaa025</identifier><identifier>PMID: 32196110</identifier><language>eng</language><publisher>OXFORD: Oxford University Press</publisher><subject>Analgesics ; Anesthesiology ; Back pain ; Clinical trials ; Double-blind studies ; Electric stimulation therapy ; Ethanol ; General &amp; Internal Medicine ; Humans ; Injection ; Intervertebral Disc Displacement ; Life Sciences &amp; Biomedicine ; Low back pain ; Low Back Pain - drug therapy ; Medicine, General &amp; Internal ; Pulsed Radiofrequency Treatment ; Quality of Life ; Science &amp; Technology ; Statistical analysis ; Treatment Outcome</subject><ispartof>Pain medicine (Malden, Mass.), 2020-11, Vol.21 (11), p.2713-2718</ispartof><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2020</rights><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.All rights reserved. For permissions, please e-mail: journals.permissions@oup.com</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>7</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000611088500058</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c345t-c13ab1645dacf401c93c34def7e3d999a687eeb86077be73d1961d3833e452b3</citedby><cites>FETCH-LOGICAL-c345t-c13ab1645dacf401c93c34def7e3d999a687eeb86077be73d1961d3833e452b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,1586,27931,27932,28255</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32196110$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Papadopoulos, Dimitrios</creatorcontrib><creatorcontrib>Batistaki, Chrysanthi</creatorcontrib><creatorcontrib>Kostopanagiotou, Georgia</creatorcontrib><title>Comparison of the Efficacy Between Intradiscal Gelified Ethanol (Discogel) Injection and Intradiscal Combination of Pulsed Radiofrequency and Gelified Ethanol (Discogel) Injection for Chronic Discogenic Low Back Pain Treatment. A Randomized Double-Blind Clinical Study</title><title>Pain medicine (Malden, Mass.)</title><addtitle>PAIN MED</addtitle><addtitle>Pain Med</addtitle><description>Abstract Objective The aim of the present study was to compare two new techniques, intradiscal gelified ethanol injection (Discogel) and the combination of intradiscal pulsed radiofrequency and gelified ethanol injection (PRF+Discogel), regarding their efficacy in discogenic low back pain treatment. Design Randomized, double-blind, clinical study. Methods The final sample was randomized into group A (N = 18, D) and group B (N = 18, PRF+D). During the procedure, four patients from group B were excluded from the study. Groups A and B were assessed regarding the pain score (VAS 0–10), before the interventional procedures, and one, three, six, and 12 months after. Secondary objectives of the study were to compare the two groups regarding the results of the Roland Morris Disability Questionnaire, Lanss score, and quality of life score (EQ-5D). Results There was no significant evidence for an overall difference in pain score between the two groups (analysis of variance, F = 3.24, df = 1, P = 0.084), except for the sixth and 12th months, when group B presented a statistically important difference compared with group A (Wilcoxon test). Group B appeared to be more effective, with a statistically significant difference, compared with group A regarding the secondary objectives of the study. Conclusions After rigorous and comprehensive assessment by an independent observer, both Discogel alone and Discogel in combination with pulsed radiofrequency produced tangible improvements in pain, function, quality of life, and consumption of analgesics, which were sustained at 12 months.</description><subject>Analgesics</subject><subject>Anesthesiology</subject><subject>Back pain</subject><subject>Clinical trials</subject><subject>Double-blind studies</subject><subject>Electric stimulation therapy</subject><subject>Ethanol</subject><subject>General &amp; Internal Medicine</subject><subject>Humans</subject><subject>Injection</subject><subject>Intervertebral Disc Displacement</subject><subject>Life Sciences &amp; Biomedicine</subject><subject>Low back pain</subject><subject>Low Back Pain - drug therapy</subject><subject>Medicine, General &amp; Internal</subject><subject>Pulsed Radiofrequency Treatment</subject><subject>Quality of Life</subject><subject>Science &amp; Technology</subject><subject>Statistical analysis</subject><subject>Treatment Outcome</subject><issn>1526-2375</issn><issn>1526-4637</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>AOWDO</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkk9v1DAQxQMC0dJy4QMgSwipBW1rx_l77KZLqbQSFew9cuwx6yWxg-NotXz6TrpLJTigXuKR3m_eGzsTRW8ZvWC05Jd9d9lbIWicPo-OWRpnsyTj-YtDHfM8PYpeD8OGUpYlBX8VHfGYlRlj9PjZaeW6XngzOEucJmENZKG1kULuyBzCFsCSWxu8UGaQoiU30BptQJFFWAvrWnJ2jYL7Ae05chuQwaCTsOqvLgxpjBUPGqbcje2AFt9QdtrDrxEsxk1NT7PXzpNq7Z01khz0qVy6LZkL-ZPcCWPJyoMIHdhwQa4wyirXmd_ofO3GpoXZvDWYV-HXTBN-D6PanUYvtcDR3hzOk2j1ebGqvsyWX29uq6vlTPIkDTPJuGjwKVMlpE4okyVHQYHOgauyLEVW5ABNkdE8byDnanpsxQvOIUnjhp9EZ3vb3ju8-xDqDi8BbSssuHGoY16wLE6yhCP6_h9040Zvcbg6TnJMYBlPkfq4p6R3w-BB1703nfC7mtF6WpG67-rDiiD87mA5Nh2oR_TPTiDwaQ9soXF6kAb_DjxilNKJKooUq7RAung6XZnwsASVG23A1g_7Vjf2_5v4HnEA6EY</recordid><startdate>20201101</startdate><enddate>20201101</enddate><creator>Papadopoulos, Dimitrios</creator><creator>Batistaki, Chrysanthi</creator><creator>Kostopanagiotou, Georgia</creator><general>Oxford University Press</general><general>Oxford Univ Press</general><scope>AOWDO</scope><scope>BLEPL</scope><scope>DTL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20201101</creationdate><title>Comparison of the Efficacy Between Intradiscal Gelified Ethanol (Discogel) Injection and Intradiscal Combination of Pulsed Radiofrequency and Gelified Ethanol (Discogel) Injection for Chronic Discogenic Low Back Pain Treatment. 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A Randomized Double-Blind Clinical Study</atitle><jtitle>Pain medicine (Malden, Mass.)</jtitle><stitle>PAIN MED</stitle><addtitle>Pain Med</addtitle><date>2020-11-01</date><risdate>2020</risdate><volume>21</volume><issue>11</issue><spage>2713</spage><epage>2718</epage><pages>2713-2718</pages><issn>1526-2375</issn><eissn>1526-4637</eissn><abstract>Abstract Objective The aim of the present study was to compare two new techniques, intradiscal gelified ethanol injection (Discogel) and the combination of intradiscal pulsed radiofrequency and gelified ethanol injection (PRF+Discogel), regarding their efficacy in discogenic low back pain treatment. Design Randomized, double-blind, clinical study. Methods The final sample was randomized into group A (N = 18, D) and group B (N = 18, PRF+D). During the procedure, four patients from group B were excluded from the study. Groups A and B were assessed regarding the pain score (VAS 0–10), before the interventional procedures, and one, three, six, and 12 months after. Secondary objectives of the study were to compare the two groups regarding the results of the Roland Morris Disability Questionnaire, Lanss score, and quality of life score (EQ-5D). Results There was no significant evidence for an overall difference in pain score between the two groups (analysis of variance, F = 3.24, df = 1, P = 0.084), except for the sixth and 12th months, when group B presented a statistically important difference compared with group A (Wilcoxon test). Group B appeared to be more effective, with a statistically significant difference, compared with group A regarding the secondary objectives of the study. Conclusions After rigorous and comprehensive assessment by an independent observer, both Discogel alone and Discogel in combination with pulsed radiofrequency produced tangible improvements in pain, function, quality of life, and consumption of analgesics, which were sustained at 12 months.</abstract><cop>OXFORD</cop><pub>Oxford University Press</pub><pmid>32196110</pmid><doi>10.1093/pm/pnaa025</doi><tpages>6</tpages></addata></record>
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subjects Analgesics
Anesthesiology
Back pain
Clinical trials
Double-blind studies
Electric stimulation therapy
Ethanol
General & Internal Medicine
Humans
Injection
Intervertebral Disc Displacement
Life Sciences & Biomedicine
Low back pain
Low Back Pain - drug therapy
Medicine, General & Internal
Pulsed Radiofrequency Treatment
Quality of Life
Science & Technology
Statistical analysis
Treatment Outcome
title Comparison of the Efficacy Between Intradiscal Gelified Ethanol (Discogel) Injection and Intradiscal Combination of Pulsed Radiofrequency and Gelified Ethanol (Discogel) Injection for Chronic Discogenic Low Back Pain Treatment. A Randomized Double-Blind Clinical Study
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