5 Study protocol for a randomized controlled trial: PAF-study 135 Appendix 1. Items World Health Organization Trial registration Data Set Data category Information Primary registry and trial identifying number The Dutch Trial registry; NTR7581 Date of registration in primary registry 12-01-2018 Secondary identifying numbers Ethical committee, NL65658.058.18 METC-nr. P18.090 Sources of monetary or material support The Dutch Association for Pelvic Physiotherapy (NVFB) Primary sponsor Proctos Clinic, Bilthoven, the Netherlands Secondary sponsor Leiden University Medical Centre, Leiden, the Netherlands Contact for public queries davr@me.com; + 31622141471; Proctos Clinic, Professor Bronkhorstlaan 10, 3723 MB Bilthoven, the Netherlands Contact for scientific queries D.A.van Reijn MSc; davr@me.com; + 31622141471; Proctos Clinic, Professor Bronkhorstlaan 10, 3723 MB Bilthoven, the Netherlands Public title Pelvic floor physical therapy in patients with chronic anal fissure Scientific title Pelvic floor physical therapy in patients with chronic anal fissure: a randomized controlled trial Country of recruitment The Netherlands Health condition or problem studied Chronic anal fissure Intervention(s) Baseline: all patients received information about the pelvic floor and related symptoms; -explanation about relevant anatomy and defecation (patho) physiology; -behavioural modifications and lifestyle advice. Intervention: 5 face-to-face appointments of a mean of 45-minutes in a period of 8 consecutive weeks; -intrarectal myofascial techniques; -pelvic floor - and breathing exercises; -surface electromyography biofeedback with an intra-anal probe (MAPLe®); neuromuscular electrical stimulation intra-anally if applicable Home exercise programme: stretching the puborectalis muscle during the application of ointment; -pelvic floor - and breathing exercises; -thermotherapy Control group: no additional treatment besides the use of ointment and fibres/laxatives. Start same treatment protocol at first follow-up (8 weeks after inclusion) Key inclusion and exclusion criteria Ages eligible for inclusion: >18 years Sexes eligible for study: both Inclusion criteria: Patients presenting chronic anal fissure and pelvic floor dysfunction; -complaints for more than 6 weeks and failed conservative treatment with ointment, fibers and/or laxatives; -sufficient understanding of the Dutch written language (reading and writing); -able to complete online questionnaires; -written informed consent Exclusion criteria: Presenting an abscess or fistula; - Crohn’s disease or ulcerative colitis; - anorectal malignancy; -previous rectal or anal surgery; -previous rectal radiation; -pregnancy
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