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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090301001722N18

Enrollment

Registered

2018-04-22

Start date

2018-05-07

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation. Constipation

Interventions

Intervention 1: biofeedback intervention: 5 sessions once a week. Intervention 2: Transcutaneous Tibial Nerve Stimulation intervention : 12 sessions, three times a week.

Eligibility

Sex/Gender

Female

Age

25 Years to 60 Years

Inclusion criteria

Inclusion criteria: Female with functional constipation aged between 25 – 55 years Definition of constipation based on Rome III criteria

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Majidirad

Rehabilitation Faculty, Tehran University of Medical Scienses

fa.majidirad@gmail.com+98 21 7753 6586

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026