A capsaicin (8%) patch in the treatment of severe persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled trial
Persistent pain after inguinal herniorrhaphy is a disabling condition with a lack of evidence-based pharmacological treatment options. This randomized placebo-controlled trial investigated the efficacy of a capsaicin 8% cutaneous patch in the treatment of severe persistent inguinal postherniorrhaphy...
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| Veröffentlicht in: | PloS one 2014-10, Vol.9 (10), p.e109144 |
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| creator | Bischoff, Joakim M Ringsted, Thomas K Petersen, Marian Sommer, Claudia Uçeyler, Nurcan Werner, Mads U |
| description | Persistent pain after inguinal herniorrhaphy is a disabling condition with a lack of evidence-based pharmacological treatment options. This randomized placebo-controlled trial investigated the efficacy of a capsaicin 8% cutaneous patch in the treatment of severe persistent inguinal postherniorrhaphy pain.
Forty-six patients with persistent inguinal postherniorrhaphy pain were randomized to receive either a capsaicin 8% patch or a placebo patch. Pain intensity (Numerical Rating Scale [NRS 0-10]) was evaluated under standardized conditions (at rest, during movement, and during pressure) at baseline and at 1, 2 and 3 months after patch application. Skin punch biopsies for intraepidermal nerve fiber density (IENFD) measurements were taken at baseline and 1 month after patch application. Quantitative sensory testing was performed at baseline and at 1, 2, and 3 months after patch application. The primary outcome was comparisons of summed pain intensity differences (SPIDs) between capsaicin and placebo treatments at 1, 2 and 3 months after patch application (significance level P < 0.01).
The maximum difference in SPID, between capsaicin and placebo treatments, was observed at 1 month after patch application, but the pain reduction was not significant (NRS, mean difference [95% CI]: 5.0 [0.09 to 9.9]; P = 0.046). No differences in SPID between treatments were observed at 2 and 3 months after patch application. Changes in IENFD on the pain side, from baseline to 1 month after patch application, did not differ between capsaicin and placebo treatment: 1.9 [-0.1 to 3.9] and 0.6 [-1.2 to 2.5] fibers/mm, respectively (P = 0.32). No significant changes in sensory function, sleep quality or psychological factors were associated with capsaicin patch treatment.
The study did not demonstrate significant differences in pain relief between capsaicin and placebo treatment, although a trend toward pain improvement in capsaicin treated patients was observed 1 month after patch application.
Clinicaltrialsregister.eu 2012-001540-22 ClinicalTrials.gov NCT01699854. |
| doi_str_mv | 10.1371/journal.pone.0109144 |
| format | Article |
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Forty-six patients with persistent inguinal postherniorrhaphy pain were randomized to receive either a capsaicin 8% patch or a placebo patch. Pain intensity (Numerical Rating Scale [NRS 0-10]) was evaluated under standardized conditions (at rest, during movement, and during pressure) at baseline and at 1, 2 and 3 months after patch application. Skin punch biopsies for intraepidermal nerve fiber density (IENFD) measurements were taken at baseline and 1 month after patch application. Quantitative sensory testing was performed at baseline and at 1, 2, and 3 months after patch application. The primary outcome was comparisons of summed pain intensity differences (SPIDs) between capsaicin and placebo treatments at 1, 2 and 3 months after patch application (significance level P < 0.01).
The maximum difference in SPID, between capsaicin and placebo treatments, was observed at 1 month after patch application, but the pain reduction was not significant (NRS, mean difference [95% CI]: 5.0 [0.09 to 9.9]; P = 0.046). No differences in SPID between treatments were observed at 2 and 3 months after patch application. Changes in IENFD on the pain side, from baseline to 1 month after patch application, did not differ between capsaicin and placebo treatment: 1.9 [-0.1 to 3.9] and 0.6 [-1.2 to 2.5] fibers/mm, respectively (P = 0.32). No significant changes in sensory function, sleep quality or psychological factors were associated with capsaicin patch treatment.
The study did not demonstrate significant differences in pain relief between capsaicin and placebo treatment, although a trend toward pain improvement in capsaicin treated patients was observed 1 month after patch application.
Clinicaltrialsregister.eu 2012-001540-22 ClinicalTrials.gov NCT01699854.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0109144</identifier><identifier>PMID: 25290151</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Aged ; Analgesics ; Anxiety ; Capsaicin ; Capsaicin - administration & dosage ; Capsaicin - adverse effects ; Clinical trials ; Double-blind studies ; Drug therapy ; Evidence-based medicine ; Female ; Hernia, Inguinal - complications ; Hernias ; Hospitals ; Humans ; Male ; Medicine and Health Sciences ; Middle Aged ; Neurosciences ; Pain ; Pain - etiology ; Pain management ; Pain Management - methods ; Pain Measurement ; Patients ; Pharmacology ; Phenols (Class of compounds) ; Psychological factors ; Randomization ; Risk Factors ; Sensory properties ; Sensory testing ; Skin ; Skin - innervation ; Sleep ; Substance abuse treatment ; Surveys and Questionnaires ; Transdermal Patch</subject><ispartof>PloS one, 2014-10, Vol.9 (10), p.e109144</ispartof><rights>COPYRIGHT 2014 Public Library of Science</rights><rights>2014 Bischoff et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2014 Bischoff et al 2014 Bischoff et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c685t-ee10c36b4062def722e5dbbc5b1ffe849683f9d10946b91cb683acc8000d4d213</citedby><cites>FETCH-LOGICAL-c685t-ee10c36b4062def722e5dbbc5b1ffe849683f9d10946b91cb683acc8000d4d213</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4188585/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4188585/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25290151$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Doherty, T. Mark</contributor><creatorcontrib>Bischoff, Joakim M</creatorcontrib><creatorcontrib>Ringsted, Thomas K</creatorcontrib><creatorcontrib>Petersen, Marian</creatorcontrib><creatorcontrib>Sommer, Claudia</creatorcontrib><creatorcontrib>Uçeyler, Nurcan</creatorcontrib><creatorcontrib>Werner, Mads U</creatorcontrib><title>A capsaicin (8%) patch in the treatment of severe persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled trial</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Persistent pain after inguinal herniorrhaphy is a disabling condition with a lack of evidence-based pharmacological treatment options. This randomized placebo-controlled trial investigated the efficacy of a capsaicin 8% cutaneous patch in the treatment of severe persistent inguinal postherniorrhaphy pain.
Forty-six patients with persistent inguinal postherniorrhaphy pain were randomized to receive either a capsaicin 8% patch or a placebo patch. Pain intensity (Numerical Rating Scale [NRS 0-10]) was evaluated under standardized conditions (at rest, during movement, and during pressure) at baseline and at 1, 2 and 3 months after patch application. Skin punch biopsies for intraepidermal nerve fiber density (IENFD) measurements were taken at baseline and 1 month after patch application. Quantitative sensory testing was performed at baseline and at 1, 2, and 3 months after patch application. The primary outcome was comparisons of summed pain intensity differences (SPIDs) between capsaicin and placebo treatments at 1, 2 and 3 months after patch application (significance level P < 0.01).
The maximum difference in SPID, between capsaicin and placebo treatments, was observed at 1 month after patch application, but the pain reduction was not significant (NRS, mean difference [95% CI]: 5.0 [0.09 to 9.9]; P = 0.046). No differences in SPID between treatments were observed at 2 and 3 months after patch application. Changes in IENFD on the pain side, from baseline to 1 month after patch application, did not differ between capsaicin and placebo treatment: 1.9 [-0.1 to 3.9] and 0.6 [-1.2 to 2.5] fibers/mm, respectively (P = 0.32). No significant changes in sensory function, sleep quality or psychological factors were associated with capsaicin patch treatment.
The study did not demonstrate significant differences in pain relief between capsaicin and placebo treatment, although a trend toward pain improvement in capsaicin treated patients was observed 1 month after patch application.
Clinicaltrialsregister.eu 2012-001540-22 ClinicalTrials.gov NCT01699854.</description><subject>Adult</subject><subject>Aged</subject><subject>Analgesics</subject><subject>Anxiety</subject><subject>Capsaicin</subject><subject>Capsaicin - administration & dosage</subject><subject>Capsaicin - adverse effects</subject><subject>Clinical trials</subject><subject>Double-blind studies</subject><subject>Drug therapy</subject><subject>Evidence-based medicine</subject><subject>Female</subject><subject>Hernia, Inguinal - complications</subject><subject>Hernias</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine and Health Sciences</subject><subject>Middle Aged</subject><subject>Neurosciences</subject><subject>Pain</subject><subject>Pain - etiology</subject><subject>Pain management</subject><subject>Pain Management - methods</subject><subject>Pain Measurement</subject><subject>Patients</subject><subject>Pharmacology</subject><subject>Phenols (Class of compounds)</subject><subject>Psychological factors</subject><subject>Randomization</subject><subject>Risk Factors</subject><subject>Sensory properties</subject><subject>Sensory testing</subject><subject>Skin</subject><subject>Skin - 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administration & dosage</topic><topic>Capsaicin - adverse effects</topic><topic>Clinical trials</topic><topic>Double-blind studies</topic><topic>Drug therapy</topic><topic>Evidence-based medicine</topic><topic>Female</topic><topic>Hernia, Inguinal - complications</topic><topic>Hernias</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Male</topic><topic>Medicine and Health Sciences</topic><topic>Middle Aged</topic><topic>Neurosciences</topic><topic>Pain</topic><topic>Pain - etiology</topic><topic>Pain management</topic><topic>Pain Management - methods</topic><topic>Pain Measurement</topic><topic>Patients</topic><topic>Pharmacology</topic><topic>Phenols (Class of compounds)</topic><topic>Psychological factors</topic><topic>Randomization</topic><topic>Risk Factors</topic><topic>Sensory properties</topic><topic>Sensory testing</topic><topic>Skin</topic><topic>Skin - innervation</topic><topic>Sleep</topic><topic>Substance abuse treatment</topic><topic>Surveys and Questionnaires</topic><topic>Transdermal Patch</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bischoff, Joakim M</creatorcontrib><creatorcontrib>Ringsted, Thomas K</creatorcontrib><creatorcontrib>Petersen, Marian</creatorcontrib><creatorcontrib>Sommer, Claudia</creatorcontrib><creatorcontrib>Uçeyler, Nurcan</creatorcontrib><creatorcontrib>Werner, Mads U</creatorcontrib><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>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological & Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - 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Mark</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A capsaicin (8%) patch in the treatment of severe persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled trial</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2014-10-07</date><risdate>2014</risdate><volume>9</volume><issue>10</issue><spage>e109144</spage><pages>e109144-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Persistent pain after inguinal herniorrhaphy is a disabling condition with a lack of evidence-based pharmacological treatment options. This randomized placebo-controlled trial investigated the efficacy of a capsaicin 8% cutaneous patch in the treatment of severe persistent inguinal postherniorrhaphy pain.
Forty-six patients with persistent inguinal postherniorrhaphy pain were randomized to receive either a capsaicin 8% patch or a placebo patch. Pain intensity (Numerical Rating Scale [NRS 0-10]) was evaluated under standardized conditions (at rest, during movement, and during pressure) at baseline and at 1, 2 and 3 months after patch application. Skin punch biopsies for intraepidermal nerve fiber density (IENFD) measurements were taken at baseline and 1 month after patch application. Quantitative sensory testing was performed at baseline and at 1, 2, and 3 months after patch application. The primary outcome was comparisons of summed pain intensity differences (SPIDs) between capsaicin and placebo treatments at 1, 2 and 3 months after patch application (significance level P < 0.01).
The maximum difference in SPID, between capsaicin and placebo treatments, was observed at 1 month after patch application, but the pain reduction was not significant (NRS, mean difference [95% CI]: 5.0 [0.09 to 9.9]; P = 0.046). No differences in SPID between treatments were observed at 2 and 3 months after patch application. Changes in IENFD on the pain side, from baseline to 1 month after patch application, did not differ between capsaicin and placebo treatment: 1.9 [-0.1 to 3.9] and 0.6 [-1.2 to 2.5] fibers/mm, respectively (P = 0.32). No significant changes in sensory function, sleep quality or psychological factors were associated with capsaicin patch treatment.
The study did not demonstrate significant differences in pain relief between capsaicin and placebo treatment, although a trend toward pain improvement in capsaicin treated patients was observed 1 month after patch application.
Clinicaltrialsregister.eu 2012-001540-22 ClinicalTrials.gov NCT01699854.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>25290151</pmid><doi>10.1371/journal.pone.0109144</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | PloS one, 2014-10, Vol.9 (10), p.e109144 |
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| source | Public Library of Science (PLoS) Journals Open Access; Open Access: PubMed Central; MEDLINE; Directory of Open Access Journals; Free Full-Text Journals in Chemistry; EZB Electronic Journals Library |
| subjects | Adult Aged Analgesics Anxiety Capsaicin Capsaicin - administration & dosage Capsaicin - adverse effects Clinical trials Double-blind studies Drug therapy Evidence-based medicine Female Hernia, Inguinal - complications Hernias Hospitals Humans Male Medicine and Health Sciences Middle Aged Neurosciences Pain Pain - etiology Pain management Pain Management - methods Pain Measurement Patients Pharmacology Phenols (Class of compounds) Psychological factors Randomization Risk Factors Sensory properties Sensory testing Skin Skin - innervation Sleep Substance abuse treatment Surveys and Questionnaires Transdermal Patch |
| title | A capsaicin (8%) patch in the treatment of severe persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-28T10%3A10%3A09IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20capsaicin%20(8%25)%20patch%20in%20the%20treatment%20of%20severe%20persistent%20inguinal%20postherniorrhaphy%20pain:%20a%20randomized,%20double-blind,%20placebo-controlled%20trial&rft.jtitle=PloS%20one&rft.au=Bischoff,%20Joakim%20M&rft.date=2014-10-07&rft.volume=9&rft.issue=10&rft.spage=e109144&rft.pages=e109144-&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0109144&rft_dat=%3Cgale_plos_%3EA418708097%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1609103423&rft_id=info:pmid/25290151&rft_galeid=A418708097&rft_doaj_id=oai_doaj_org_article_aa0f6ea4810e455aa2267059121d2c98&rfr_iscdi=true |