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Transcutaneous posterior tibial nerve stimulation in children and adolescents with functional constipation: A protocol for an interventional study
A vast majority of children with functional constipation respond to the standard medical treatment. However, a subset of patients may present with an unsatisfactory response and only minor improvement of symptoms. Transcutaneous posterior tibial nerve stimulation (PTNS) involves electrical stimulati...
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Published in: | Medicine (Baltimore) 2019-11, Vol.98 (45), p.e17755-e17755 |
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description | A vast majority of children with functional constipation respond to the standard medical treatment. However, a subset of patients may present with an unsatisfactory response and only minor improvement of symptoms. Transcutaneous posterior tibial nerve stimulation (PTNS) involves electrical stimulation of the posterior tibial nerve at the level of the ankle, transcutaneously through electrodes fixated on the overlying skin. Stimulation of the tibial nerve can modulate urinary and defecatory function through the stimulation of sacral nerves. Thus, transcutaneous PTNS can be considered a very promising, noninvasive, and safe method to be used in the pediatric age group. However, there is still no published study that has investigated its use in children for the treatment of intestinal constipation. This is a single-center, prospective, longitudinal, and interventional study designed to assess the applicability and clinical outcomes of transcutaneous PTNS in children with functional intestinal constipation. Children will be submitted to daily sessions of transcutaneous PTNS for a period of 4 weeks. All children will also be invited to participate in semistructured interviews, 1 in each of the 3 assessments: 1 week before the start of the intervention; immediately after the 4 weeks of intervention; and 4 weeks after the end of the intervention period. In these interviews, the aspects related to bowel habits and quality of life will be assessed. This project aims to evaluate the clinical outcomes of transcutaneous PTNS in children with functional intestinal constipation and the applicability of this kind of treatment.
This protocol intended to demonstrate the efficacy of this promising method to increase the number of bowel movements and the stool consistency, to reduce the number of episodes of retentive fecal incontinence, and to indirectly improve the overall quality of life. |
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This protocol intended to demonstrate the efficacy of this promising method to increase the number of bowel movements and the stool consistency, to reduce the number of episodes of retentive fecal incontinence, and to indirectly improve the overall quality of life.</description><identifier>ISSN: 0025-7974</identifier><identifier>EISSN: 1536-5964</identifier><identifier>DOI: 10.1097/MD.0000000000017755</identifier><identifier>PMID: 31702626</identifier><language>eng</language><publisher>United States: the Author(s). Published by Wolters Kluwer Health, Inc</publisher><subject>Adolescent ; Child ; Clinical Trials as Topic ; Constipation - therapy ; Fecal Incontinence - therapy ; Humans ; Longitudinal Studies ; Male ; Prospective Studies ; Quality of Life ; Study Protocol Clinical Trial ; Tibial Nerve - physiology ; Transcutaneous Electric Nerve Stimulation - adverse effects ; Transcutaneous Electric Nerve Stimulation - methods ; Treatment Outcome</subject><ispartof>Medicine (Baltimore), 2019-11, Vol.98 (45), p.e17755-e17755</ispartof><rights>the Author(s). Published by Wolters Kluwer Health, Inc.</rights><rights>Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc. 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3550-10e19a76b51b7e6eed08a4be4a49629e579cb3aaf6c22f9a30f692b4e19ce21c3</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/PMC6855522/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6855522/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31702626$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rego, Rebeca Mayara Padilha</creatorcontrib><creatorcontrib>Machado, Nilton Carlos</creatorcontrib><creatorcontrib>Carvalho, Mary de Assis</creatorcontrib><creatorcontrib>Graffunder, Johann Souza</creatorcontrib><creatorcontrib>Ortolan, Erika Veruska Paiva</creatorcontrib><creatorcontrib>Lourenção, Pedro Luiz Toledo de Arruda</creatorcontrib><title>Transcutaneous posterior tibial nerve stimulation in children and adolescents with functional constipation: A protocol for an interventional study</title><title>Medicine (Baltimore)</title><addtitle>Medicine (Baltimore)</addtitle><description>A vast majority of children with functional constipation respond to the standard medical treatment. However, a subset of patients may present with an unsatisfactory response and only minor improvement of symptoms. Transcutaneous posterior tibial nerve stimulation (PTNS) involves electrical stimulation of the posterior tibial nerve at the level of the ankle, transcutaneously through electrodes fixated on the overlying skin. Stimulation of the tibial nerve can modulate urinary and defecatory function through the stimulation of sacral nerves. Thus, transcutaneous PTNS can be considered a very promising, noninvasive, and safe method to be used in the pediatric age group. However, there is still no published study that has investigated its use in children for the treatment of intestinal constipation. This is a single-center, prospective, longitudinal, and interventional study designed to assess the applicability and clinical outcomes of transcutaneous PTNS in children with functional intestinal constipation. Children will be submitted to daily sessions of transcutaneous PTNS for a period of 4 weeks. All children will also be invited to participate in semistructured interviews, 1 in each of the 3 assessments: 1 week before the start of the intervention; immediately after the 4 weeks of intervention; and 4 weeks after the end of the intervention period. In these interviews, the aspects related to bowel habits and quality of life will be assessed. This project aims to evaluate the clinical outcomes of transcutaneous PTNS in children with functional intestinal constipation and the applicability of this kind of treatment.
This protocol intended to demonstrate the efficacy of this promising method to increase the number of bowel movements and the stool consistency, to reduce the number of episodes of retentive fecal incontinence, and to indirectly improve the overall quality of life.</description><subject>Adolescent</subject><subject>Child</subject><subject>Clinical Trials as Topic</subject><subject>Constipation - therapy</subject><subject>Fecal Incontinence - therapy</subject><subject>Humans</subject><subject>Longitudinal Studies</subject><subject>Male</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Study Protocol Clinical Trial</subject><subject>Tibial Nerve - physiology</subject><subject>Transcutaneous Electric Nerve Stimulation - adverse effects</subject><subject>Transcutaneous Electric Nerve Stimulation - methods</subject><subject>Treatment Outcome</subject><issn>0025-7974</issn><issn>1536-5964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNpdkV1vFCEYhYnR2LX6C0wMl95M5WNgFi9MmrZakzbe1GvCMO84KAsrMN30b_QXy3TX-sENCTznvHAOQq8pOaFEde-uz0_In0W7TognaEUFl41Qsn2KVoQw0XSqa4_Qi5y_V4h3rH2OjjjtCJNMrtD9TTIh27mYAHHOeBtzgeRiwsX1zngcIN0CzsVtZm-KiwG7gO3k_JAgYBMGbIboIVsIJeOdKxMe52AXsqptDFW6fRC-x6d4m2KJNno81glm8SqLfzjguczD3Uv0bDQ-w6vDfoy-fry4Obtsrr58-nx2etVYLgRpKAGqTCd7QfsOJMBA1qbtoTWtkkyB6JTtuTGjtIyNynAySsX6tqosMGr5Mfqw993O_QaG5QPJeL1NbmPSnY7G6X9vgpv0t3ir5VoIwVg1eHswSPHnDLnojas5eL_PUjNOOZdsrURF-R61KeacYHwcQ4le2tTX5_r_Nqvqzd8vfNT8rq8C7R7YRV-DzD_8vIOkJzC-TA9-NQXWMEIVpWRNmnrCCP8FbM6wKg</recordid><startdate>20191101</startdate><enddate>20191101</enddate><creator>Rego, Rebeca Mayara Padilha</creator><creator>Machado, Nilton Carlos</creator><creator>Carvalho, Mary de Assis</creator><creator>Graffunder, Johann Souza</creator><creator>Ortolan, Erika Veruska Paiva</creator><creator>Lourenção, Pedro Luiz Toledo de Arruda</creator><general>the Author(s). Published by Wolters Kluwer Health, Inc</general><general>Wolters Kluwer Health</general><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>7X8</scope><scope>5PM</scope></search><sort><creationdate>20191101</creationdate><title>Transcutaneous posterior tibial nerve stimulation in children and adolescents with functional constipation: A protocol for an interventional study</title><author>Rego, Rebeca Mayara Padilha ; Machado, Nilton Carlos ; Carvalho, Mary de Assis ; Graffunder, Johann Souza ; Ortolan, Erika Veruska Paiva ; Lourenção, Pedro Luiz Toledo de Arruda</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3550-10e19a76b51b7e6eed08a4be4a49629e579cb3aaf6c22f9a30f692b4e19ce21c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adolescent</topic><topic>Child</topic><topic>Clinical Trials as Topic</topic><topic>Constipation - therapy</topic><topic>Fecal Incontinence - therapy</topic><topic>Humans</topic><topic>Longitudinal Studies</topic><topic>Male</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Study Protocol Clinical Trial</topic><topic>Tibial Nerve - physiology</topic><topic>Transcutaneous Electric Nerve Stimulation - adverse effects</topic><topic>Transcutaneous Electric Nerve Stimulation - methods</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rego, Rebeca Mayara Padilha</creatorcontrib><creatorcontrib>Machado, Nilton Carlos</creatorcontrib><creatorcontrib>Carvalho, Mary de Assis</creatorcontrib><creatorcontrib>Graffunder, Johann Souza</creatorcontrib><creatorcontrib>Ortolan, Erika Veruska Paiva</creatorcontrib><creatorcontrib>Lourenção, Pedro Luiz Toledo de Arruda</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Medicine (Baltimore)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rego, Rebeca Mayara Padilha</au><au>Machado, Nilton Carlos</au><au>Carvalho, Mary de Assis</au><au>Graffunder, Johann Souza</au><au>Ortolan, Erika Veruska Paiva</au><au>Lourenção, Pedro Luiz Toledo de Arruda</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transcutaneous posterior tibial nerve stimulation in children and adolescents with functional constipation: A protocol for an interventional study</atitle><jtitle>Medicine (Baltimore)</jtitle><addtitle>Medicine (Baltimore)</addtitle><date>2019-11-01</date><risdate>2019</risdate><volume>98</volume><issue>45</issue><spage>e17755</spage><epage>e17755</epage><pages>e17755-e17755</pages><issn>0025-7974</issn><eissn>1536-5964</eissn><abstract>A vast majority of children with functional constipation respond to the standard medical treatment. However, a subset of patients may present with an unsatisfactory response and only minor improvement of symptoms. Transcutaneous posterior tibial nerve stimulation (PTNS) involves electrical stimulation of the posterior tibial nerve at the level of the ankle, transcutaneously through electrodes fixated on the overlying skin. Stimulation of the tibial nerve can modulate urinary and defecatory function through the stimulation of sacral nerves. Thus, transcutaneous PTNS can be considered a very promising, noninvasive, and safe method to be used in the pediatric age group. However, there is still no published study that has investigated its use in children for the treatment of intestinal constipation. This is a single-center, prospective, longitudinal, and interventional study designed to assess the applicability and clinical outcomes of transcutaneous PTNS in children with functional intestinal constipation. Children will be submitted to daily sessions of transcutaneous PTNS for a period of 4 weeks. All children will also be invited to participate in semistructured interviews, 1 in each of the 3 assessments: 1 week before the start of the intervention; immediately after the 4 weeks of intervention; and 4 weeks after the end of the intervention period. In these interviews, the aspects related to bowel habits and quality of life will be assessed. This project aims to evaluate the clinical outcomes of transcutaneous PTNS in children with functional intestinal constipation and the applicability of this kind of treatment.
This protocol intended to demonstrate the efficacy of this promising method to increase the number of bowel movements and the stool consistency, to reduce the number of episodes of retentive fecal incontinence, and to indirectly improve the overall quality of life.</abstract><cop>United States</cop><pub>the Author(s). Published by Wolters Kluwer Health, Inc</pub><pmid>31702626</pmid><doi>10.1097/MD.0000000000017755</doi><oa>free_for_read</oa></addata></record> |
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subjects | Adolescent Child Clinical Trials as Topic Constipation - therapy Fecal Incontinence - therapy Humans Longitudinal Studies Male Prospective Studies Quality of Life Study Protocol Clinical Trial Tibial Nerve - physiology Transcutaneous Electric Nerve Stimulation - adverse effects Transcutaneous Electric Nerve Stimulation - methods Treatment Outcome |
title | Transcutaneous posterior tibial nerve stimulation in children and adolescents with functional constipation: A protocol for an interventional study |
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