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Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain - a randomized, placebo-controlled trial
Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC) of nonivamide (a capsaicinoid) and nicoboxil (a nicotinic acid ester) cream...
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| Published in: | Journal of pain research 2016-01, Vol.9, p.1221-1230 |
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| container_title | Journal of pain research |
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| creator | Blahova, Zuzana Holm, Janina Claudia Weiser, Thomas Richter, Erika Trampisch, Matthias Akarachkova, Elena |
| description | Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC) of nonivamide (a capsaicinoid) and nicoboxil (a nicotinic acid ester) cream in the treatment of acute nonspecific low back pain.
This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1.08%/nonivamide 0.17% (Finalgon
cream) in treatment of acute nonspecific low back pain with the endpoints: pain intensity (PI) difference between pre-dose baseline and 8 hours after first application and the end of treatment, mobility score, and efficacy score.
Patients (n=138), 21-65 years of age, were treated for up to 4 days with FDC or placebo cream. Mean baseline PI was 6.8 on a 0-10 point numerical rating scale. After 8 hours, pain was more reduced with the FDC than with placebo (adjusted means: 2.824 vs. 0.975 points; |
| doi_str_mv | 10.2147/JPR.S118329 |
| format | article |
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This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1.08%/nonivamide 0.17% (Finalgon
cream) in treatment of acute nonspecific low back pain with the endpoints: pain intensity (PI) difference between pre-dose baseline and 8 hours after first application and the end of treatment, mobility score, and efficacy score.
Patients (n=138), 21-65 years of age, were treated for up to 4 days with FDC or placebo cream. Mean baseline PI was 6.8 on a 0-10 point numerical rating scale. After 8 hours, pain was more reduced with the FDC than with placebo (adjusted means: 2.824 vs. 0.975 points;
<0.0001). On the last treatment day, mean pain reduction by the FDC was stronger than with placebo (adjusted means: 5.132 vs. 2.174 points;
<0.0001). Mobility on Day 1 was in favor of the FDC when compared to placebo (odds ratio [95% confidence interval {CI}]: 7.200 [3.609, 14.363],
<0.0001). At the end of treatment, patients treated with the FDC rated efficacy significantly higher than placebo (odds ratio [95% CI]: 11.370 [5.342, 24.199],
<0.0001). Both treatments were tolerated well. No serious adverse events were reported.
Nicoboxil/nonivamide cream is an effective and safe treatment for acute nonspecific low back pain, adding a promising treatment option.</description><identifier>ISSN: 1178-7090</identifier><identifier>EISSN: 1178-7090</identifier><identifier>DOI: 10.2147/JPR.S118329</identifier><identifier>PMID: 28008281</identifier><language>eng</language><publisher>New Zealand: Dove Medical Press Limited</publisher><subject>acute low back pain ; Analgesics ; Back pain ; Backache ; Care and treatment ; Clinical trials ; Drug dosages ; mobility score ; Narcotics ; nicoboxil ; nonivamide ; Nonsteroidal anti-inflammatory drugs ; Original Research ; Pain ; pain intensity reduction ; Patients ; Systematic review ; topical cream</subject><ispartof>Journal of pain research, 2016-01, Vol.9, p.1221-1230</ispartof><rights>COPYRIGHT 2016 Dove Medical Press Limited</rights><rights>2016. This work is licensed under https://creativecommons.org/licenses/by-nc/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2016 Blahova et al. This work is published and licensed by Dove Medical Press Limited 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c536t-1d85bbbe9778a28f645d5d5c1e04f13f868927b3c11e73419439096362833f493</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2229799690/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2229799690?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28008281$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Blahova, Zuzana</creatorcontrib><creatorcontrib>Holm, Janina Claudia</creatorcontrib><creatorcontrib>Weiser, Thomas</creatorcontrib><creatorcontrib>Richter, Erika</creatorcontrib><creatorcontrib>Trampisch, Matthias</creatorcontrib><creatorcontrib>Akarachkova, Elena</creatorcontrib><title>Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain - a randomized, placebo-controlled trial</title><title>Journal of pain research</title><addtitle>J Pain Res</addtitle><description>Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC) of nonivamide (a capsaicinoid) and nicoboxil (a nicotinic acid ester) cream in the treatment of acute nonspecific low back pain.
This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1.08%/nonivamide 0.17% (Finalgon
cream) in treatment of acute nonspecific low back pain with the endpoints: pain intensity (PI) difference between pre-dose baseline and 8 hours after first application and the end of treatment, mobility score, and efficacy score.
Patients (n=138), 21-65 years of age, were treated for up to 4 days with FDC or placebo cream. Mean baseline PI was 6.8 on a 0-10 point numerical rating scale. After 8 hours, pain was more reduced with the FDC than with placebo (adjusted means: 2.824 vs. 0.975 points;
<0.0001). On the last treatment day, mean pain reduction by the FDC was stronger than with placebo (adjusted means: 5.132 vs. 2.174 points;
<0.0001). Mobility on Day 1 was in favor of the FDC when compared to placebo (odds ratio [95% confidence interval {CI}]: 7.200 [3.609, 14.363],
<0.0001). At the end of treatment, patients treated with the FDC rated efficacy significantly higher than placebo (odds ratio [95% CI]: 11.370 [5.342, 24.199],
<0.0001). Both treatments were tolerated well. No serious adverse events were reported.
Nicoboxil/nonivamide cream is an effective and safe treatment for acute nonspecific low back pain, adding a promising treatment option.</description><subject>acute low back pain</subject><subject>Analgesics</subject><subject>Back pain</subject><subject>Backache</subject><subject>Care and treatment</subject><subject>Clinical trials</subject><subject>Drug dosages</subject><subject>mobility score</subject><subject>Narcotics</subject><subject>nicoboxil</subject><subject>nonivamide</subject><subject>Nonsteroidal anti-inflammatory drugs</subject><subject>Original Research</subject><subject>Pain</subject><subject>pain intensity reduction</subject><subject>Patients</subject><subject>Systematic review</subject><subject>topical cream</subject><issn>1178-7090</issn><issn>1178-7090</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNptUl1rFDEUHUSxtfrkuwQEEXS2-ZjJx4tQih-VouLHc8hkbnazZibbzMxqffSXm-2uZVfkPuRyc84J9-QUxWOCZ5RU4vT9p8-zL4RIRtWd4pgQIUuBFb671x8VD4ZhiTGXVJH7xRGVGEsqyXHx-4O3sYk_fTjtY-_XpvMtIJvAdAicAzv6NYRrZPoWDcZt2gTtZGFAxk4joMwaVmC98xaF-AM1xn5HK-N7VCKDUubFzv-C9iVaBWOhiaWN_ZhiCNCiMXkTHhb3nAkDPNqdJ8W3N6-_nr8rLz--vTg_uyxtzfhYklbWTdOAEkIaKh2v6jaXJYArR5iTXCoqGmYJAcEqoiqmsOKMU8mYqxQ7KS62um00S71KvjPpWkfj9c0gprk2afQ2gCYV4xyckQ13FResUcBq4RilTjGBbdZ6tdVaTU0HrYW8kgkHooc3vV_oeVzrmnBRKZwFnu8EUryaYBh15wcLIZge4jRoImsqJCW1yNCn_0CXcUp9tkpTSpVQit8I7lBzkxfwvYv5XbsR1Wc1ztngvN54MPsPKlcLXQ5CD87n-QHh2R5hASaMiyGGafT53w-BL7ZAm-IwJHC3ZhCsNznVOad6l9OMfrLv3y32bzDZH8Ip4R0</recordid><startdate>20160101</startdate><enddate>20160101</enddate><creator>Blahova, Zuzana</creator><creator>Holm, Janina Claudia</creator><creator>Weiser, Thomas</creator><creator>Richter, Erika</creator><creator>Trampisch, Matthias</creator><creator>Akarachkova, Elena</creator><general>Dove Medical Press Limited</general><general>Taylor & Francis Ltd</general><general>Dove Medical Press</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7XB</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20160101</creationdate><title>Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain - a randomized, placebo-controlled trial</title><author>Blahova, Zuzana ; Holm, Janina Claudia ; Weiser, Thomas ; Richter, Erika ; Trampisch, Matthias ; Akarachkova, Elena</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c536t-1d85bbbe9778a28f645d5d5c1e04f13f868927b3c11e73419439096362833f493</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>acute low back pain</topic><topic>Analgesics</topic><topic>Back pain</topic><topic>Backache</topic><topic>Care and treatment</topic><topic>Clinical trials</topic><topic>Drug dosages</topic><topic>mobility score</topic><topic>Narcotics</topic><topic>nicoboxil</topic><topic>nonivamide</topic><topic>Nonsteroidal anti-inflammatory drugs</topic><topic>Original Research</topic><topic>Pain</topic><topic>pain intensity reduction</topic><topic>Patients</topic><topic>Systematic review</topic><topic>topical cream</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Blahova, Zuzana</creatorcontrib><creatorcontrib>Holm, Janina Claudia</creatorcontrib><creatorcontrib>Weiser, Thomas</creatorcontrib><creatorcontrib>Richter, Erika</creatorcontrib><creatorcontrib>Trampisch, Matthias</creatorcontrib><creatorcontrib>Akarachkova, Elena</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Publicly Available Content Database</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 Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>Directory of Open Access Journals</collection><jtitle>Journal of pain research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Blahova, Zuzana</au><au>Holm, Janina Claudia</au><au>Weiser, Thomas</au><au>Richter, Erika</au><au>Trampisch, Matthias</au><au>Akarachkova, Elena</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain - a randomized, placebo-controlled trial</atitle><jtitle>Journal of pain research</jtitle><addtitle>J Pain Res</addtitle><date>2016-01-01</date><risdate>2016</risdate><volume>9</volume><spage>1221</spage><epage>1230</epage><pages>1221-1230</pages><issn>1178-7090</issn><eissn>1178-7090</eissn><abstract>Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC) of nonivamide (a capsaicinoid) and nicoboxil (a nicotinic acid ester) cream in the treatment of acute nonspecific low back pain.
This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1.08%/nonivamide 0.17% (Finalgon
cream) in treatment of acute nonspecific low back pain with the endpoints: pain intensity (PI) difference between pre-dose baseline and 8 hours after first application and the end of treatment, mobility score, and efficacy score.
Patients (n=138), 21-65 years of age, were treated for up to 4 days with FDC or placebo cream. Mean baseline PI was 6.8 on a 0-10 point numerical rating scale. After 8 hours, pain was more reduced with the FDC than with placebo (adjusted means: 2.824 vs. 0.975 points;
<0.0001). On the last treatment day, mean pain reduction by the FDC was stronger than with placebo (adjusted means: 5.132 vs. 2.174 points;
<0.0001). Mobility on Day 1 was in favor of the FDC when compared to placebo (odds ratio [95% confidence interval {CI}]: 7.200 [3.609, 14.363],
<0.0001). At the end of treatment, patients treated with the FDC rated efficacy significantly higher than placebo (odds ratio [95% CI]: 11.370 [5.342, 24.199],
<0.0001). Both treatments were tolerated well. No serious adverse events were reported.
Nicoboxil/nonivamide cream is an effective and safe treatment for acute nonspecific low back pain, adding a promising treatment option.</abstract><cop>New Zealand</cop><pub>Dove Medical Press Limited</pub><pmid>28008281</pmid><doi>10.2147/JPR.S118329</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| source | Publicly Available Content Database; Taylor & Francis Open Access Journals; IngentaConnect Journals; PubMed Central |
| subjects | acute low back pain Analgesics Back pain Backache Care and treatment Clinical trials Drug dosages mobility score Narcotics nicoboxil nonivamide Nonsteroidal anti-inflammatory drugs Original Research Pain pain intensity reduction Patients Systematic review topical cream |
| title | Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain - a randomized, placebo-controlled trial |
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