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. 2021 Nov 16:24:100874.
doi: 10.1016/j.conctc.2021.100874. eCollection 2021 Dec.

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

Daniëlle A van Reijn-Baggen  1   2 , Henk W Elzevier  2 , Rob C M Pelger  2 , Ingrid J M Han-Geurts  1
Affiliations

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

Daniëlle A van Reijn-Baggen et al. Contemp Clin Trials Commun. .

Abstract

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.

Keywords: Anal pain; Biofeedback; Chronic anal fissure; Pelvic floor physical therapy.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Study design flow diagram.
See this image and copyright information in PMC

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