Osteopathic Visceral Manipulation on Functional Constipation in Obese Adults

Osteopathic Visceral Manipulation on Functional Constipation in Obese Adults: Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Constipation - Functional
• Intervention / Treatment: Other: visceral manipulation

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 4450113
    • faculty of physical therapy ,Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: osteopathic visceral manipulation; Group A received osteopathic visceral manipulation with standard care	Other: visceral manipulation; 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.; Other Names: standard care only
No Intervention: control; Group B received standard care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defecation frequency	Utilize a standardized stool diary where participants record each defecation event, including the date	at baseline and at three weeks
Dose of oral laxative	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	at baseline and at three weeks

Collaborators and Investigators

• Sponsor: MTI University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Actual): April 25, 2025
• Study Completion (Actual): April 25, 2025

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: IRB # 22 /3 / 2024-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No