Back to resultsEffect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation
Primary Purpose
Constipation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices
Sponsored by
About this trial
This is an interventional treatment trial for Constipation
Eligibility Criteria
Inclusion Criteria:•Postpartum women, delivered by caesarean section suffering from constipation after delivery.
- 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
-
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
bilateral transcutaneous tibial nerve stimulation,exercise and advices
Exercises and advices
Arm Description
•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.
They will perform abdominal muscle training and breathing exercise three times per week, for 4 weeks in addition to bowel care advices.
Outcomes
Primary Outcome Measures
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 .
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 .
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 .
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05455853
Brief Title
Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation
Official Title
Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bilateral transcutaneous tibial nerve stimulation,exercise and advices
Arm Type
Experimental
Arm Description
•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.
Arm Title
Exercises and advices
Arm Type
Experimental
Arm Description
They will perform abdominal muscle training and breathing exercise three times per week, for 4 weeks in addition to bowel care advices.
Intervention Type
Other
Intervention Name(s)
Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices
Other Intervention Name(s)
Exercises and advices
Intervention Description
• 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.
Primary Outcome Measure Information:
Title
The Bristol Stool Form Scale (BSFS)
Description
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 .
Time Frame
up to 4 weeks
Title
Patient Assessment of Constipation -Symptom Questionnaire (PAC-SYM)
Description
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 .
Time Frame
up to 4 weeks
Title
Patient Assessment of constipation quality of life questionnaire (PAC-QOL)
Description
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 .
Time Frame
up to 4 weeks
Title
Rome III criteria: Rome III criteria: Rome III criteria
Description
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.
Time Frame
up to 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:•Postpartum women, delivered by caesarean section suffering from constipation after delivery.
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
-
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manal Ahmed El-Shafei, Lecturer
Phone
01220664518
Email
manalpt1989@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation
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