Osteopathic Visceral Manipulation on Functional Constipation in Obese Adults: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Stool consistency
研究概览
简要总结
Functional constipation in obese adults is a prevalent gastrointestinal issue characterized by infrequent bowel movements, difficulty during defecation, or a sensation of incomplete evacuation. Obesity is a significant risk factor for functional constipation due to several physiological and lifestyle-related factors. Excess body weight, particularly in the abdominal region, may exert pressure on the colon, leading to disrupted bowel function. Additionally, dietary habits common among obese individuals, such as low fiber intake and inadequate hydration, can worsen constipation. Sedentary lifestyles further contribute to reduced gastrointestinal motility. Addressing functional constipation in obese adults requires a multifaceted approach, including dietary modifications to increase fiber and fluid intake, regular physical activity, and, in some cases, medical interventions to alleviate symptoms and improve quality of life.
详细描述
Visceral manipulation is a gentle manual therapy that focuses on the internal organs, particularly those within the gastrointestinal tract, to enhance their function and alleviate symptoms associated with various disorders. Practitioners of visceral manipulation use their hands to apply specific, subtle forces to the affected areas, aiming to improve the mobility and motility of the organs. This technique is based on the premise that the body's organs are interconnected by fascia and ligaments, and any restriction or imbalance in these connections can lead to dysfunction and disease. By restoring the natural movement of these organs, visceral manipulation is believed to improve blood circulation, enhance digestive function, and reduce pain and discomfort associated with gastrointestinal disorders.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with functional constipation according to Rome IV criteria
- •Body mass index (BMI) ≥ 30 kg/m²
- •Ability to provide informed consent
排除标准
- •patients with organic gastrointestinal diseases, Pregnancy or lactation
- •Participation in another clinical trial within the last 30 days, Endocrine and metabolic disorders (eg, hypothyroidism, hypercalcemia, diabetes mellitus, diabetes insipidus)
- •Neurologic and psychiatric disorders (spina bifida, cerebral palsy, anorexia nervosa, known autism spectrum disorders)
- •Secondary constipation to drug consumption, History of abdominal surgery
研究组 & 干预措施
control
Group B received standard care only
osteopathic visceral manipulation
Group A received osteopathic visceral manipulation with standard care
干预措施: visceral manipulation (Other)
结局指标
主要结局
Stool consistency
时间窗: at baseline and at three weeks
Patients were asked to describe the consistency of their stools during the previous month, choosing between the terms "hard or very hard," "not too hard, not too soft (normal)," "soft or very soft," "mucous, with undigested food," and "liquid," they also had the opportunity to answer that the stools were "variable" in consistency. In addition, patients were asked to choose the BSS stool type that best represented their stools on a picture chart
Defecation Pain
时间窗: at baseline and at three weeks
Clearly explain to the patient the purpose of assessing their defecation pain using Arabic version of Visual Analogue Scale (VAS) form: A horizontal or vertical line, typically 10 centimeters in length, anchored by two descriptors at each end representing "no pain" and "worst possible pain."
次要结局
- Defecation frequency(at baseline and at three weeks)
- Dose of oral laxative(at baseline and at three weeks)
研究者
Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d
Assisstant professor
MTI University