Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF-study): Study protocol for a randomized controlled trial

Background: Chronic anal fissure (CAF) is a common cause of severe anorectal pain with a high incidence rate. Currently, a wide range of treatment options are available with recurrence rates varying between 7 and 42%. Pelvic floor physical therapy (PFPT) is a treatment option for increased pelvic fl...

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Autores principales:	Daniëlle A. van Reijn-Baggen, Henk W. Elzevier, Rob C.M. Pelger, Ingrid J.M. Han-Geurts
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Chronic anal fissure Anal pain Pelvic floor physical therapy Biofeedback Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/692c5511fd3d45a4a8d13e8dd2caf287
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spelling	oai:doaj.org-article:692c5511fd3d45a4a8d13e8dd2caf2872021-11-20T05:08:09ZPelvic floor physical therapy in the treatment of chronic anal fissure (PAF-study): Study protocol for a randomized controlled trial2451-865410.1016/j.conctc.2021.100874https://doaj.org/article/692c5511fd3d45a4a8d13e8dd2caf2872021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2451865421001745https://doaj.org/toc/2451-8654Background: Chronic anal fissure (CAF) is a common cause of severe anorectal pain with a high incidence rate. Currently, a wide range of treatment options are available with recurrence rates varying between 7 and 42%. Pelvic floor physical therapy (PFPT) is a treatment option for increased pelvic floor muscle tone and dyssynergia which often accompanies CAF. However, literature on this subject is scarce. The Pelvic Floor Anal Fissure (PAF)-study aims to determine the efficacy and effectiveness of PFPT on improvement on pelvic floor muscle tone and function, pain, healing of the fissure, quality of life and complaint reduction in patients with CAF. Methods: The PAF-study is a single-centre, two armed, randomized controlled trial. Patients with CAF and pelvic floor dysfunction are eligible for inclusion. Exclusion criteria include abscess, fistula, Crohn's disease, ulcerative colitis, anorectal malignancy, prior rectal radiation, and pregnancy. A total of 140 patients will be randomized for either PFPT or postponed treatment of PFPT.The primary outcome is tone at rest during electromyographic registration of the pelvic floor before and after therapy. Secondary outcomes consist of healing of the fissure, pain ratings, improvement of pelvic floor function, complaint reduction and quality of life. Primary and secondary endpoints are measured at 8 and 20 weeks and at 1-year follow-up. Discussion: Currently, there is a gap in treatment modalities between conservative management and surgery. This manuscript prescribes the rationale, design, and methodology of a randomized controlled trial investigating PFPT as a treatment option for patients with CAF.Daniëlle A. van Reijn-BaggenHenk W. ElzevierRob C.M. PelgerIngrid J.M. Han-GeurtsElsevierarticleChronic anal fissureAnal painPelvic floor physical therapyBiofeedbackMedicine (General)R5-920ENContemporary Clinical Trials Communications, Vol 24, Iss , Pp 100874- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Chronic anal fissure Anal pain Pelvic floor physical therapy Biofeedback Medicine (General) R5-920
spellingShingle	Chronic anal fissure Anal pain Pelvic floor physical therapy Biofeedback Medicine (General) R5-920 Daniëlle A. van Reijn-Baggen Henk W. Elzevier Rob C.M. Pelger Ingrid J.M. Han-Geurts Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF-study): Study protocol for a randomized controlled trial
description	Background: Chronic anal fissure (CAF) is a common cause of severe anorectal pain with a high incidence rate. Currently, a wide range of treatment options are available with recurrence rates varying between 7 and 42%. Pelvic floor physical therapy (PFPT) is a treatment option for increased pelvic floor muscle tone and dyssynergia which often accompanies CAF. However, literature on this subject is scarce. The Pelvic Floor Anal Fissure (PAF)-study aims to determine the efficacy and effectiveness of PFPT on improvement on pelvic floor muscle tone and function, pain, healing of the fissure, quality of life and complaint reduction in patients with CAF. Methods: The PAF-study is a single-centre, two armed, randomized controlled trial. Patients with CAF and pelvic floor dysfunction are eligible for inclusion. Exclusion criteria include abscess, fistula, Crohn's disease, ulcerative colitis, anorectal malignancy, prior rectal radiation, and pregnancy. A total of 140 patients will be randomized for either PFPT or postponed treatment of PFPT.The primary outcome is tone at rest during electromyographic registration of the pelvic floor before and after therapy. Secondary outcomes consist of healing of the fissure, pain ratings, improvement of pelvic floor function, complaint reduction and quality of life. Primary and secondary endpoints are measured at 8 and 20 weeks and at 1-year follow-up. Discussion: Currently, there is a gap in treatment modalities between conservative management and surgery. This manuscript prescribes the rationale, design, and methodology of a randomized controlled trial investigating PFPT as a treatment option for patients with CAF.
format	article
author	Daniëlle A. van Reijn-Baggen Henk W. Elzevier Rob C.M. Pelger Ingrid J.M. Han-Geurts
author_facet	Daniëlle A. van Reijn-Baggen Henk W. Elzevier Rob C.M. Pelger Ingrid J.M. Han-Geurts
author_sort	Daniëlle A. van Reijn-Baggen
title	Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF-study): Study protocol for a randomized controlled trial
title_short	Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF-study): Study protocol for a randomized controlled trial
title_full	Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF-study): Study protocol for a randomized controlled trial
title_fullStr	Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF-study): Study protocol for a randomized controlled trial
title_full_unstemmed	Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF-study): Study protocol for a randomized controlled trial
title_sort	pelvic floor physical therapy in the treatment of chronic anal fissure (paf-study): study protocol for a randomized controlled trial
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/692c5511fd3d45a4a8d13e8dd2caf287
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Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF-study): Study protocol for a randomized controlled trial

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