5 Study protocol for a randomized controlled trial: PAF-study 137 Appendix 2. TIDieR checklist Pelvic floor physical therapy in Chronic Anal Fissure (PAF-study) Brief name Pelvic floor physical therapy in patients with chronic anal fissure: a randomized controlled trial 1. Intervention PFPT including biofeedback vs postponed PFPT 2. Why 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. 3. What Baseline information by pelvic floor physical therapist/PI for all patients: Information about the pelvic floor and related symptoms, defecation physiology, behavioural modifications, and lifestyle advice (s.e toilet advice, stress reduction). Patients continue fibers and/or laxatives. Patients use ointment 2-3 times a day, before and after defecation and before sleep. Baseline diagnostics by PI for all patients: Digital rectal examination: the patient placed in left lateral position hip flexed at 700 and knees flexed at 90.0 After inspection of the anus, the inserted finger is carefully and slowly advanced into the rectum. The resting sphincter tone is assessed in rest and scored as normal, decreased, or increased. Pelvic floor muscle tone is scored as; normal, decreased, or increased. The patient is asked to squeeze as strong and fast as possible for 10 times, and to squeeze and hold as long as possible (up to 30 seconds). In addition to the finger in the rectum, a hand is placed over the patient’s abdomen to assess the push effort. The patient is asked to push and bear down as if to defecate. Push effort of the anal-and pelvic floor muscles is scored as relaxation, indifferent or paradoxal contraction. S-EMG measurement: S-EMG is performed with an anal probe (MAPLe®). This is a probe with a matrix of 24 electrodes enabling measuring EMG-signals from the different sides and layers of the PF muscle. The probe is placed intra-anal, the grounding electrode placed on the spina iliaca anterior superior. The patient is asked to perform four consecutive tasks according to a standardized protocol: 1) one-minute rest where participants are instructed to relax and breathe normally; 2) ten maximum voluntary contractions (MVC) where the patient is verbally instructed to perform a short controlled (maximum) contraction for one second without contracting the muscles surrounding the pelvic floor and relax the pelvic floor muscles between the MVC contractions for 3 seconds; 3) one endurance contraction where the patient is instructed to contract the pelvic floor muscles at such a level that they could hold for 30 seconds, without contracting the muscles surrounding the pelvic floor; 4) one push effort where the patient is asked to push and bear down. The investigator is holding the probe to keep it in place. During these examinations, no instructions were given on how to perform a correct pelvic floor muscle contraction. From these s-EMG measurements, mean EMG amplitudes per electrode are calculated. The EMG mean values are presented as absolute values (µV).
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