Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation

NCT ID: NCT05455853

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2022-11-01

Brief Summary

This study will be conduct to determine the effect of bilateral transcutaneous tibial nerve stimulation on treating postpartum constipation

Detailed Description

TTNS was effective in treating constipation .It was believed that re-establishment of normal colonic function may be possible with neuromodulation of sacral nerve stimulation (SNS) that may improve constipation symptoms but it is expensive and invasive . Percutaneous tibial nerve stimulation (PTNS) is an alternative method of neuromodulation that has shown efficacy in constipation and it stimulates L4-S3 nerve roots of sacral plexus that supply the pelvic floor and lower gastrointestinal tract, Transcutaneous tibial nerve stimulation (TTNS) targets the tibial nerve in a similar fashion to PTNS but it is cheaper and does not require needle puncture .There were few studies showed that TTNS has been used and shown to be effective for treating constipation, but till now, there is no previous study illustrating it's effect specifically on postpartum constipation. So, this study will be the first one in this issue.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

bilateral transcutaneous tibial nerve stimulation,exercise and advices

•They will receive bilateral transcutaneous tibial nerve stimulation three times per week for 4 weeks, in addition to abdominal muscle training and breathing exercise and bowel care advices.

Group Type: EXPERIMENTAL

Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices

Intervention Type: OTHER

• First group they will receive morning bilateral transcutaneous tibial nerve stimulation, for 30 minutes, three times per week for 4 weeks, in addition to abdominal muscle training and breathing exercise for 15 minutes three times per week, for 4 weeks and bowel care advices.•They will perform abdominal muscle training and breathing exercise, for 15 minutes three times per week, for 4 weeks in addition to bowel care advices.

Second group•They will perform abdominal muscle training and breathing exercise, for 15 minutes three times per week, for 4 weeks in addition to bowel care advices.

Exercises and advices

They will perform abdominal muscle training and breathing exercise three times per week, for 4 weeks in addition to bowel care advices.

Group Type: EXPERIMENTAL

Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices

Intervention Type: OTHER

• First group they will receive morning bilateral transcutaneous tibial nerve stimulation, for 30 minutes, three times per week for 4 weeks, in addition to abdominal muscle training and breathing exercise for 15 minutes three times per week, for 4 weeks and bowel care advices.•They will perform abdominal muscle training and breathing exercise, for 15 minutes three times per week, for 4 weeks in addition to bowel care advices.

Second group•They will perform abdominal muscle training and breathing exercise, for 15 minutes three times per week, for 4 weeks in addition to bowel care advices.

Interventions

Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices

• First group they will receive morning bilateral transcutaneous tibial nerve stimulation, for 30 minutes, three times per week for 4 weeks, in addition to abdominal muscle training and breathing exercise for 15 minutes three times per week, for 4 weeks and bowel care advices.•They will perform abdominal muscle training and breathing exercise, for 15 minutes three times per week, for 4 weeks in addition to bowel care advices.

Second group•They will perform abdominal muscle training and breathing exercise, for 15 minutes three times per week, for 4 weeks in addition to bowel care advices.

Intervention Type: OTHER

Other Intervention Names

Exercises and advices

Eligibility Criteria

Inclusion Criteria

• Their ages will range from 20 to 35 years old.
• Their body mass index (BMI) will range from 25 to 33 kg/m2.
• All participating women should have at least two criteria of Rome III diagnostic criteria for constipation.

They should stop laxatives intake during treatment program

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Exclusion Criteria

Postpartum women will be excluded if they have:

• History of inflammatory bowel disease, and irritable bowel syndrome.
• Endocrine disease or digestive tract disease.
• History of genital prolapse and anal fissure.
• Congental anorectal malformation, stoma in situ.
• Diabtes mellitus and sever distal venous insuffiency.
• Skin eruption at the site of stimulation.
• Implanted pacemaker or defibrillator.
• Metalic implant in lower limb.
• Recent surgery at the lower limb.
• Peripheral neuropathy and neurological disorders. Psychological distress.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

walaa salah mohammed ahmed

spechalist of physical therapist at qulin hospital ,kafrelshikh,Egypt .

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Manal Ahmed El-Shafei, Lecturer

Role: CONTACT

manalpt1989@gmail.com

01220664518

Other Identifiers

P.T.Rec/012/003728

Identifier Type: -

Identifier Source: org_study_id