Osteopathic Visceral Manipulation on Functional Constipation in Obese Adults

Not Applicable

Completed

• Conditions: Constipation - Functional

• Registration Number: NCT06925802
• Lead Sponsor: MTI University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-03-25
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-11
• Study First Posted: 2025-04-13
• Primary Completion: 2025-04-25
• Study Completion: 2025-04-25
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• patients diagnosed with functional constipation according to Rome IV criteria
• Body mass index (BMI) ≥ 30 kg/m²
• Ability to provide informed consent

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stool consistency	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	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."

Secondary Outcome Measures

Name	Time	Method
Defecation frequency	at baseline and at three weeks	Utilize a standardized stool diary where participants record each defecation event, including the date
Dose of oral laxative	at baseline and at three weeks	dose of oral laxative and time. Ensure the diary is easy to use to promote accurate self-reporting. Supplement diary entries with qualitative interviews to understand lifestyle, dietary habits, and stress levels, which may influence bowel movement

Trial Locations

Locations (1)

faculty of physical therapy ,Cairo University; 🇪🇬 Cairo, Egypt