Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation

NCT05455853 | Unknown

• 1 other identifier: P.T.Rec/012/003728
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Constipation

Outcome Measures

Primary Outcomes (4)

• The Bristol Stool Form Scale (BSFS)

  It is a formal research tool used to assess stool consistency and intestinal transit rate. It is an ordinal scale used to rate and categorize stool into seven classifications, according to stool consistency It is also useful in evaluating the effectiveness of an intervention for gastrointestinal tract disease and clinical assessment. It helps people to report on stool consistency adequately, thus proving a guide in the diagnosis and treatment of gastrointestinal disorders.It classifies stool into seven categories ranging from hard lumps like nuts stool (type 1) to watery without solid pieces, entirely liquid (type 7). Types 1 and 2 are indicative of constipation, types 3 and 4 are considered normal stool consistency that is easy to defecate, while types 6 and 7 are considered abnormal consistency .

  up to 4 weeks

• Patient Assessment of Constipation -Symptom Questionnaire (PAC-SYM)

  It is frequently used in clinical trials of constipation, it has emerged as an important tool for assessing the severity of patient-reported symptoms of constipation. It consists of 12-item questionnaire that divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden. Observational data have shown that PAC-SYM questionnaire has internal consistency, test-retest reliability and concurrent validity, and to be responsive to change over time .

  up to 4 weeks

• Patient Assessment of constipation quality of life questionnaire (PAC-QOL)

  The validated PAC-QOL questionnaire consists of 28 items grouped into 4 subscales ; physical discomfort , psychosocial discomfort, in addition to worries and concerns, and satisfaction, investigating the effects of constipation on the patient's quality of life in the recent 2 weeks. The first three subscale comprise the patient dissatisfaction index (where higher great corresponding to worse quality of life) the satisfaction subscale include 4 items, (where higher great corresponding to improve quality of life .

  up to 4 weeks

• Rome III criteria: Rome III criteria: Rome III criteria

  It will be used to confirm the diagnosis of constipation for all participating women in both groups A and B to ensure that they will meet the eligibility criteria . All women should have at least two of the following criteria: Fewer than three spontaneous bowel movements per week. Straining during at least 25% of defecation attempts. Lumpy or hard stools for at least 25% of defecation attempts. Sensation of anorectal obstruction or blockage for at least 25% of defecation attempts. Sensation of incomplete defecation for at least 25% of defecation attempts. Manual maneuvering required to defecate for at least 25% of defecation attempts (e.g., digital evacuation, support of the pelvic floor). Loose stools are rarely present without the use of laxatives.

  up to 4 weeks

Study Arms (2)

bilateral transcutaneous tibial nerve stimulation,exercise and advices

EXPERIMENTAL

•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.

Other: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices

Exercises and advices

EXPERIMENTAL

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

Other: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices

Interventions

Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices 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.

Also known as: Exercises and advices

Exercises and advices; bilateral transcutaneous tibial nerve stimulation,exercise and advices

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Constipation

Interventions

Exercise; Counseling

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Manal Ahmed El-Shafei, Lecturer

CONTACT

01220664518; manalpt1989@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: spechalist of physical therapist at qulin hospital ,kafrelshikh,Egypt .

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: August 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share