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IRCT20090301001722N18 IRCT 2018-04-22 Tehran University of Medical Sciences Effects of transcutaneous nerve stimulation with biofeedback on physiological and clinical factors in female with constipation To compare the effects of neuromodulation (transcutaneous tibial nerve stimulation(TTNS)) with manometric biofeedback on physiological and clinical factors in female with functional constipation 2018-05-07 anticipated 30 Complete https://irct.ir/trial/1221 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization The name of each group is written on a separate paper and the patient randomly chooses the own intervention group. N/A Constipation. Intervention 1: biofeedback intervention: 5 sessions once a week. Intervention 2: Transcutaneous Tibial Nerve Stimulation intervention : 12 sessions, three times a week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Fatemeh Majidirad
Rehabilitation Faculty, Enghelab street
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 6586 fa.majidirad@gmail.com Rehabilitation Faculty, Tehran University of Medical Scienses scientific Dr. Mohammad Reza Hadian
Rehabilitation Faculty, Enghelab Ave
Tehran Iran (Islamic Republic of) 65111-11489 +98 21 7753 3939 hadianrs@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Female with functional constipation aged between 25 – 55 years Definition of constipation based on Rome III criteria 25 years 60 years Female The patient withdrew cooperation Pregnant or wishing to become pregnant History of neurologic diseases such as multiple sclerosis, stroke, or spinal cord injury Metabolic disorder such as diabetes, hypothyroidism, hypercalcaemia History of Congenital anorectal malformations History of previous large-bowel surgery or cancer History of irritable bowel syndrome Take anticholinergic or other constipating medications Skin eruptions at the site of stimulation History of recent surgery to the lower limb Metal implant in the lower limb Abnormal rectal sensation Failure of Traditional treatment K59.0 Constipation Rehabilitation Rehabilitation biofeedback intervention: 5 sessions once a week Transcutaneous Tibial Nerve Stimulation intervention : 12 sessions, three times a week Anal canal resting pressure. Timepoint: before and after of intervention. Method of measurement: anorectal manometry. Rectoanal inhibitory reflex. Timepoint: before and after of intervention. Method of measurement: anorectal manometry. Urge volume. Timepoint: before and after of intervention. Method of measurement: anorectal manometry. Max tolerable volume. Timepoint: before and after of intervention. Method of measurement: anorectal manometry. Max rectal pressure during sraining. Timepoint: before and after of intervention. Method of measurement: anorectal manometry. Balloon expulsion test. Timepoint: before and after of intervention. Method of measurement: stopwatch. Bowel movement. Timepoint: before and after of intervention. Method of measurement: wexner questionnaire. Total score of wexner questionnaire. Timepoint: before and after of intervention. Method of measurement: wexner questionnaire. Scores of 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and physical and mental component summary of SF36. Timepoint: Before and after of intervention. Method of measurement: SF36 questionnaire. Score of total and 4 scales (physical discomfort, psychosocial discomfort, worries and discomfort and treatment satisfaction) of Patient Assessment Constipation Quality Of Life (PAC-QOL) questionnaire. Timepoint: Before and after of intervention. Method of measurement: PAC-QOL questionnaire. Tehran University of Medical Sciences Approved 2017-08-30 Ethics committee of Rehabilitation Faculty of Tehran University of Medical Sciense Piche shemiran, Enghelab Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)