5 Study protocol for a randomized controlled trial: PAF-study 139 Brief name Pelvic floor physical therapy in patients with chronic anal fissure: a randomized controlled trial 5. Who provided PFPT is provided by pelvic floor physical therapists in the Netherlands. They are registered at the Dutch Association for Pelvic Physiotherapy (NVFB). They are all trained and educated in the performance of invasive techniques, as is used during digital rectal examination, rectal techniques, and biofeedback in men and women. All therapists had training in the use of biofeedback with the MAPLe®. The pelvic floor physical therapist of the Proctos Clinic and principal investigator of the study was responsible for the first diagnostic evaluation of the pelvic floor including EMG-measurement, baseline information and follow-up appointments at 8 - and 20 weeks and 1 year. 6. How Face-to face 7. Where First meeting and follow-up appointments at 8 -and 20 weeks and 1-year follow-up at the Proctos Clinic in the Netherlands Treatment with pelvic floor physical therapist in a private practice, near patients’ residence. 8. When, and how much Baseline and follow- up: at 8, 20 weeks and one year: 4 appointments of 45 minutes PFPT: 5 sessions in a period of 8-10 weeks (30-45 minutes) Postponed PFPT: at first follow-up, at 8 weeks after inclusion start treatment with the same treatment protocol 9. Tailoring The interventions are tailored to the patient based on results and findings of the diagnostic evaluation of the pelvic floor at every visit. 10. Modifications No modification was made 11.How well Appointments at the private practices are monitored by clinicians delivering the intervention. Monitoring at fixed time points (followup) includes an appointment with the surgeon and pelvic floor physical therapist/PI at the Proctos Clinic. PAF-study= Pelvic floor Anal Fissure- study; PFPT= Pelvic Floor Physical Therapy; CAF= chronic anal fissure; PI= principal investigator; s-EMG= surface electromyography Appendix 2. Continued
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