Osteopathic Visceral Manipulation on Functional Constipation in Obese Adults

NCT06925802 | Completed

• 1 other identifier: IRB # 22 /3 / 2024-2025
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (2)

• Stool consistency

  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

  at baseline and at three weeks

• Defecation Pain

  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."

  at baseline and at three weeks

Secondary Outcomes (2)

• Defecation frequency

  at baseline and at three weeks

• Dose of oral laxative

  at baseline and at three weeks

Study Arms (2)

osteopathic visceral manipulation

EXPERIMENTAL

Group A received osteopathic visceral manipulation with standard care

Other: visceral manipulation

control

NO INTERVENTION

Group B received standard care only

Interventions

visceral manipulation OTHER

The procedure begins with the patient lying in a comfortable supine position to ensure relaxation and access to the abdominal region. Gentle palpation is used to assess tissue mobility and identify any restrictions or tension points. The practitioner applies light, rhythmic pressure to the gastroduodenal junction to stimulate movement and improve coordination between the stomach and duodenum. Attention is then given to the sphincter of Oddi, where soft, sustained pressure is employed to facilitate the release of bile and pancreatic juices, aiding digestive processes. Moving to the duodenojejunal flexure, the therapist uses gentle stretching and mobilization techniques to alleviate any obstructions, promoting smoother passage of intestinal contents. Finally, the sigmoid colon is manipulated with circular and oscillatory pressures to enhance peristalsis and relieve constipation.

Also known as: standard care only

osteopathic visceral manipulation

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

faculty of physical therapy ,Cairo University

Cairo, 4450113, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor

Model Details: RCT

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: March 25, 2025
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)