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IRCT20250812066839N1 IRCT 2025-08-26 Iran University of Medical Sciences Tibial Nerve Stimulation in Chronic Functional Constipation The Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Symptoms of Chronic Functional Constipation by Evaluation of Parasympathetic System through Hemodynamic Monitoring and Salivary Acetylcholinesterase Biomarker 2025-09-11 anticipated 30 Complete https://irct.ir/trial/85513 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: The randomization method will be based on simple random allocation rule through lottery-based method. Specifically, 15 balls labeled “A” (control group) and 15 balls labeled “B” (intervention group) will be placed in a container and then drawn one at a time without replacement. The sequence of drawn balls will be recorded, creating a random allocation sequence, Blinding description: Participants will be randomly assigned, without their knowledge, to either the control or intervention group. Accordingly, none of the participants will be aware of the existence of two treatment arms. Additionally, data analysts will remain blinded to group allocation (control vs. intervention) throughout the analysis process. N/A Functional Constipation. Intervention 1: Control group: Participants will receive conventional pelvic floor physiotherapy, which includes biofeedback using a rectal electrode for retraining and strengthening the anorectal muscles, prescription of pelvic floor muscle stretching and strengthening exercises, diaphragmatic breathing instruction, and bowel behavioral therapy. Treatment sessions will be conducted three times per week over a six-week period. Intervention 2: Intervention group: The intervention will consist of two components initiated concurrently: conventional pelvic floor physiotherapy and tibial nerve electrical stimulation. Conventional pelvic floor physiotherapy includes biofeedback using a rectal electrode for retraining and strengthening the anorectal muscles, prescription of pelvic floor muscle stretching and strengthening exercises, diaphragmatic breathing instruction, and bowel behavioral therapy. Treatment sessions will be conducted three times per week over a six-week period. Tibial nerve electrical stimulation will be administered via a home-use electrical stimulation device for 30 minutes each morning upon waking, continued daily for six weeks. 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 No further information is provided at this stage
public Parnian Mirbehresi
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari Street, Mirdamad, Madar Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 pbehresi@gmail.com Iran University of Medical Sciences scientific Parnian Mirbehresi
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari Street, Mirdamad, Madar Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 2059 pbehresi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Female participants aged 20 to 60 years who meet the Rome III criteria for chronic functional constipation 20 years 60 years Female Currently receiving any other treatment for chronic functional constipation Previous treatment for chronic functional constipation within the past month Presence of any organic disorder known to cause constipation Diagnosis of neurological disorders (multiple sclerosis, Parkinson’s disease, or spinal cord injury) Presence of diabetic neuropathy Presence of congenital anomalies of the anorectal region Presence of anatomical disorders requiring surgical intervention (mucosal prolapse, rectocele, cystocele) as determined by a specialist Suffering from major depression (Beck Depression Inventory score > 30) Use of medications known to induce constipation (e.g., antidepressants, antihistamines, antiepileptic drugs) Previous anorectal surgery Current pregnancy or intention to become pregnant Prescence of periodontal disease K59.0 Constipation Rehabilitation Rehabilitation Control group: Participants will receive conventional pelvic floor physiotherapy, which includes biofeedback using a rectal electrode for retraining and strengthening the anorectal muscles, prescription of pelvic floor muscle stretching and strengthening exercises, diaphragmatic breathing instruction, and bowel behavioral therapy. Treatment sessions will be conducted three times per week over a six-week period. Intervention group: The intervention will consist of two components initiated concurrently: conventional pelvic floor physiotherapy and tibial nerve electrical stimulation. Conventional pelvic floor physiotherapy includes biofeedback using a rectal electrode for retraining and strengthening the anorectal muscles, prescription of pelvic floor muscle stretching and strengthening exercises, diaphragmatic breathing instruction, and bowel behavioral therapy. Treatment sessions will be conducted three times per week over a six-week period. Tibial nerve electrical stimulation will be administered via a home-use electrical stimulation device for 30 minutes each morning upon waking, continued daily for six weeks. Salivary acetylcholine esterase. Timepoint: Baseline (prior to intervention), midpoint, and end of study. Method of measurement: Collection of unstimulated saliva sample and analysis using an acetylcholinesterase assay kit. Hear Rate Variability. Timepoint: Baseline (prior to intervention), midpoint, and end of study. Method of measurement: Electrocardiography. Clinical symptoms of chronic functional constipation. Timepoint: Baseline (prior to intervention), midpoint, and end of study. Method of measurement: Wexner constipation scoring system questionnaire. Quality of life. Timepoint: Baseline (prior to intervention), midpoint, and end of study. Method of measurement: Patient Assessment of Constipation-Quality of Life questionnaire. Iran University of Medical Sciences Approved 2024-09-03 Research Ethics Committees of Iran University of Medical Sciences School of Rehabilitation Science, Nezam Ave, Mirdamad Ave, Tehran, Tehran Tehran Iran (Islamic Republic of)