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 |
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creator | Papadopoulos, Dimitrios 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. |
doi_str_mv | 10.1093/pm/pnaa025 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_2381624643</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/pm/pnaa025</oup_id><sourcerecordid>2381624643</sourcerecordid><originalsourceid>FETCH-LOGICAL-c345t-c13ab1645dacf401c93c34def7e3d999a687eeb86077be73d1961d3833e452b3</originalsourceid><addsrcrecordid>eNqNkk9v1DAQxQMC0dJy4QMgSwipBW1rx_l77KZLqbQSFew9cuwx6yWxg-NotXz6TrpLJTigXuKR3m_eGzsTRW8ZvWC05Jd9d9lbIWicPo-OWRpnsyTj-YtDHfM8PYpeD8OGUpYlBX8VHfGYlRlj9PjZaeW6XngzOEucJmENZKG1kULuyBzCFsCSWxu8UGaQoiU30BptQJFFWAvrWnJ2jYL7Ae05chuQwaCTsOqvLgxpjBUPGqbcje2AFt9QdtrDrxEsxk1NT7PXzpNq7Z01khz0qVy6LZkL-ZPcCWPJyoMIHdhwQa4wyirXmd_ofO3GpoXZvDWYV-HXTBN-D6PanUYvtcDR3hzOk2j1ebGqvsyWX29uq6vlTPIkDTPJuGjwKVMlpE4okyVHQYHOgauyLEVW5ABNkdE8byDnanpsxQvOIUnjhp9EZ3vb3ju8-xDqDi8BbSssuHGoY16wLE6yhCP6_h9040Zvcbg6TnJMYBlPkfq4p6R3w-BB1703nfC7mtF6WpG67-rDiiD87mA5Nh2oR_TPTiDwaQ9soXF6kAb_DjxilNKJKooUq7RAung6XZnwsASVG23A1g_7Vjf2_5v4HnEA6EY</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2478601635</pqid></control><display><type>article</type><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><source>MEDLINE</source><source>Oxford University Press Journals All Titles (1996-Current)</source><source>Web of Science - Science Citation Index Expanded - 2020<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" /></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 & 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</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 & Internal Medicine</subject><subject>Humans</subject><subject>Injection</subject><subject>Intervertebral Disc Displacement</subject><subject>Life Sciences & Biomedicine</subject><subject>Low back pain</subject><subject>Low Back Pain - drug therapy</subject><subject>Medicine, General & Internal</subject><subject>Pulsed Radiofrequency Treatment</subject><subject>Quality of Life</subject><subject>Science & 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. A Randomized Double-Blind Clinical Study</title><author>Papadopoulos, Dimitrios ; Batistaki, Chrysanthi ; Kostopanagiotou, Georgia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c345t-c13ab1645dacf401c93c34def7e3d999a687eeb86077be73d1961d3833e452b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Analgesics</topic><topic>Anesthesiology</topic><topic>Back pain</topic><topic>Clinical trials</topic><topic>Double-blind studies</topic><topic>Electric stimulation therapy</topic><topic>Ethanol</topic><topic>General & Internal Medicine</topic><topic>Humans</topic><topic>Injection</topic><topic>Intervertebral Disc Displacement</topic><topic>Life Sciences & Biomedicine</topic><topic>Low back pain</topic><topic>Low Back Pain - drug therapy</topic><topic>Medicine, General & Internal</topic><topic>Pulsed Radiofrequency Treatment</topic><topic>Quality of Life</topic><topic>Science & Technology</topic><topic>Statistical analysis</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Papadopoulos, Dimitrios</creatorcontrib><creatorcontrib>Batistaki, Chrysanthi</creatorcontrib><creatorcontrib>Kostopanagiotou, Georgia</creatorcontrib><collection>Web of Science - Science Citation Index Expanded - 2020</collection><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Pain medicine (Malden, Mass.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Papadopoulos, Dimitrios</au><au>Batistaki, Chrysanthi</au><au>Kostopanagiotou, Georgia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</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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