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IRCT20140811018760N6 IRCT 2020-03-06 Tabriz University of Medical Sciences Effect of biofeedback in chronic constipation The comparison between the effects of biofeedback with pelvic floor muscle training and biofeedback alone on chronic constipation in adult females: a randomized controlled trial 2020-02-19 anticipated 66 Complete https://irct.ir/trial/44221 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Adult women with chronic constipation, if appropriate, were randomly assigned in the two intervention and control groups using blocks of size 6 and 9 blocks with 1: 1 allocation ratio. For the allocation concealment, the type of intervention received is written on a piece of paper and placed inside the opaque envelopes and the back of the envelope will be numbered. The envelopes will be opened according to the entry of the participants and the type of group for each patient will be specified accordingly, Blinding description: This study will be single blinded. Because of exercise nature in one group , participants in this study cannot be blind in which group they are. So only the investigator (data assessor) will be blind. The statistician will also be blind. N/A Chronic constipation. Intervention 1: Intervention group 1: Individuals in this group will receive Visual Therapy with Enraf (632x Myomed) biofeedback device, two 30- minute sessions per week, for 3 months. Step 1, Patient education and awareness;The paradoxical state of sphincter voluntary contraction or inability to relax the anal muscles during excretion is explained to the patient. Pushing during excretion (like stool excretion): At this stage, superficial electrodes are placed on the abdominal muscles to determine how they are operated during excretion. Stage III; Pelvic floor relaxation technique: At this stage the patient is flanked and the rectal probe is placed by the therapist then the patient will be taught how to facilitate the rectal canal and the rectum using a biofeedback monitor. Last step; the patient is asked to relax the anal canal while exerting pressure on the abdomen (abdominal rectus muscle and diaphragm). In the first stage, the breathing technique must be corrected when attempting to defecate. Bearing down maneuvers are taught to the patient. Intervention 2: Intervention group 2: In this group, the biofeedback intervention will be performed as in the previous group and the graded supervised pelvic floor muscle exercises will be conducted by physiotherapist for each patient. The patient will perform one session per week of exercise under the supervision of a physiotherapist and will be given progressive exercise weekly. 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 Fariba Ghaderi
Rehabilitation Faculty, Daneshgah avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5167631444 +98 41 3334 5121 ghaderif@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Fariba Ghaderi
Rehabilitation Faculty, Daneshgah avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5167631444 +98 41 3334 5121 ghaderif@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Symptoms of chronic constipation for 6 month No drug use in intervention groups during last two weeks Age range of 18-54 years 18 years 54 years Female Presence of systemic diseases Irritable bowel syndrome Secondary constipation anatomical, endocrine, metabolic, neurological, surgical factors Blood diseases or taking anticoagulants drug such as Heparin and Warfarin Abdominal aneurysm Pregnant and lactating women Presence Pacemaker Psychological and psychiatric disorders Addiction and Alcohol abuse Understanding problems K59.0 Constipation Treatment - Other Treatment - Other Intervention group 1: Individuals in this group will receive Visual Therapy with Enraf (632x Myomed) biofeedback device, two 30- minute sessions per week, for 3 months. Step 1, Patient education and awareness;The paradoxical state of sphincter voluntary contraction or inability to relax the anal muscles during excretion is explained to the patient. Pushing during excretion (like stool excretion): At this stage, superficial electrodes are placed on the abdominal muscles to determine how they are operated during excretion. Stage III; Pelvic floor relaxation technique: At this stage the patient is flanked and the rectal probe is placed by the therapist then the patient will be taught how to facilitate the rectal canal and the rectum using a biofeedback monitor. Last step; the patient is asked to relax the anal canal while exerting pressure on the abdomen (abdominal rectus muscle and diaphragm). In the first stage, the breathing technique must be corrected when attempting to defecate. Bearing down maneuvers are taught to the patient. Intervention group 2: In this group, the biofeedback intervention will be performed as in the previous group and the graded supervised pelvic floor muscle exercises will be conducted by physiotherapist for each patient. The patient will perform one session per week of exercise under the supervision of a physiotherapist and will be given progressive exercise weekly. Constipation severity. Timepoint: Before intervention and at the end of the intervention. Method of measurement: Comprehensive constipation questionnaire. Evaluation of the intensity of anal sphincter muscle activity. Timepoint: Before intervention and at the end of the intervention. Method of measurement: The intensity of sphincter muscle activity will be measured using an electromyograph (EMG). Evaluation intensity of abdominal muscle activity. Timepoint: Before intervention and at the end of the intervention. Method of measurement: The intensity of abdominal muscles activity will be measured using an electromyograph (EMG). Evaluation anal resting pressure. Timepoint: Before intervention and at the end of the intervention. Method of measurement: The anal resting pressure will be measured using the anorectal manometery. Evaluation anal squeeze pressure. Timepoint: Before intervention and at the end of the intervention. Method of measurement: The anal squeeze pressure will be measured using the anorectal manometery. Tabriz University of Medical Sciences Approved 2019-12-08 Ethics committee of Tabriz University of Medical Sciences Rehabilitation faculty, Daneshgah avenue, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)