Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Patient Assessment of constipation quality of life questionnaire (PAC-QOL)
研究概览
简要总结
This study will be conduct to determine the effect of bilateral transcutaneous tibial nerve stimulation on treating postpartum constipation
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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/m
- •All participating women should have at least two criteria of Rome III diagnostic criteria for constipation.
- •They should stop laxatives intake during treatment program
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices (Other)
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.
干预措施: Experimental: bilateral transcutaneous tibial nerve stimulation,exercise and advices (Other)
结局指标
主要结局
Patient Assessment of constipation quality of life questionnaire (PAC-QOL)
时间窗: up to 4 weeks
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 .
The Bristol Stool Form Scale (BSFS)
时间窗: up to 4 weeks
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)
时间窗: up to 4 weeks
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 .
Rome III criteria: Rome III criteria: Rome III criteria
时间窗: up to 4 weeks
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.
次要结局
未报告次要终点
研究者
walaa salah mohammed ahmed
spechalist of physical therapist at qulin hospital ,kafrelshikh,Egypt .
Cairo University