Danielle van Reijn-Baggen

5 Study protocol for a randomized controlled trial: PAF-study 129 the randomization sequence. The PI, who will also be involved in the data analysis is not blinded for allocation. The PI will inform the patient about group allocation and follow-up appointments. The PI will also be responsible for communication with the collaborating pelvic floor physical therapist and inform them by telephone call about allocated intervention and other complementary information of the patient. The letter of referral will be sent by a secure online mail system. Baseline Demographics and physical examination Demographic characteristics will be collected including age, gender, and relevant history. Clinical data will be collected including previous treatment, duration of symptoms and findings on clinical examination regarding fissure and pelvic floor dysfunction. To examine pelvic floor muscle tone, strength, endurance and relaxation of the pelvic floor muscles, a careful functional digital rectal examination will be performed.30-32 Dyssynergia is detected by rectal examination 33 and balloon expulsion test.34,35 Besides that, pelvic floor muscle tone and function is measured with s-EMG30,36 with an intraanal probe (MAPLe®).37 This probe has a matrix of 24 electrodes and is capable of providing electro galvanic stimulation and registering s-EMG-activity nearest to the individual muscles of the pelvic floor during diagnosis and treatment.37 Patients are asked to perform four consecutive tasks: one-minute rest, ten maximum voluntary contractions, one endurance contraction of thirty seconds and one push effort where the patient is asked to bear down. The MAPLe® system is validated for its purpose.37,38 Questionnaires Patients are asked to fill in three validated questionnaires online. To quantify the average intensity of pain during defecation, a visual analog scale (VAS) will be used on a 11-point scale from 0 (no pain) to 10 (most intense pain).39 Quality of life is measured using the RAND-36 Health Status Inventory.40 The RAND36 questionnaire entails nine domains of health-related quality of life pertaining to both physical health (physical functioning, role limitations resulting from physical health, pain, general health perceptions), mental health (emotional well- being, role limitations resulting from emotional problems, social functioning, energy/fatigue) and health change. The score for each scale is obtained by the sum of the scores for

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