Effect of Abdominal Massage Versus Visceral Manipulation on Constipation Status and Quality of Life in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Bowel Function Index
研究概览
简要总结
The study compares the effect of abdominal massage vs. visceral manipulation on constipation status and quality of life in adults.
Chronic idiopathic constipation (CIC) is considered a common functional bowel disorder characterized by difficult, infrequent, and/or incomplete defecation. It has a great impact on the quality of life and on the healthcare system and represents an important financial strain .
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sex with age ranges (20-40) years old.
- •having a diagnosis of functional constipation according to Rome IV criteria onset of constipation symptoms from 6-12 months .
- •having body mass index 18.5-29.9 kg/m2 , waist height ratio </=0.5
- •Subjects bothered by their constipation
排除标准
- •Pregnancy.
- •Having comorbidities (chronic pelvic pain, neurological (Parkinson's, multiple sclerosis, spinal cord lesion, etc.), metabolic / endocrine (diabetes mellitus, hypercalcemia, hypothyroid, etc.), cardiorespiratory diseases
- •Health problems which may prevent standing from sitting, walking (orthopedic, neurological, cardiorespiratory, etc.)
- •Malignancy, acute inflammation, intestinal tumor
- •History of gastrointestinal and pelvic surgery or spinal surgery other than cholecystectomy, appendectomy, or hysterectomy
- •Visual, auditory or cognitive problems which may prevent participation to the study.
- •Tumor, presence of skin problems in the application area
- •Presence of laxative use for functional constipation in the last four weeks or patients on laxative therapy.
- •Alarm symptoms (unexplained, more than 10% weight loss in 3 months, hemorrhoids and anal fissures, rectal bleeding, family history of colon cancer)
结局指标
主要结局
Bowel Function Index
时间窗: 6 weeks
(Scale 0 - 100), will be calculated as the mean of three variables (ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation) was developed to evaluate bowel function.
Patient Assessment of Constipation- Quality of Life (PAC-QOL) Questionnaire
时间窗: 6 weeks
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. PAC-QOL consists a total of 28 items in four subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life.
Constipation Severity Instrument (CSI)
时间窗: 6 weeks
Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. The Constipation Severity Instrument is a 16-item patient-reported outcome measure that investigates symptoms of constipation based on frequency, severity, and bother of symptoms. CSI consists of three subscales: obstructive defecation, colonic inertia, and pain. Higher scores of CSI indicate more severe constipation.
Constipation Assessment Scale
时间窗: 6 weeks
Constipation assessment scale will be used to evaluate the severity of the constipation. The constipation assessment scale is a eight-item scale that assess the presence and severity of constipation. The patient rates each constipation item on a three-point scale (no problem to severe problem). Total scores range from 0 (no constipation) to 16 (worst possible constipation).
次要结局
未报告次要终点
研究者
Mennat Allah Mohamed Ali Ahmed
head of department of physical therapy AboKhalefa hospital
Cairo University