Visceral Osteopathy in Functional Constipation

The Effectiveness of Visceral Osteopathy in Functional Constipation: A Randomized Controlled Trial

It is a functional bowel disease characterized by excessive straining during defecation, infrequent defecation, and the feeling of incomplete evacuation. There are very few studies investigating the incidence and prevalence of functional constipation.Non-pharmacological treatment methods, including lifestyle changes, are primarily recommended for the treatment of constipation. The aim of the study is to examine the effects of visceral osteopathic approaches on individuals diagnosed with functional constipation and compare them with conventional methods.

Study Overview

• Status: Completed
• Conditions: Functional Constipation
• Intervention / Treatment: Dietary supplement: conservative treatment; Other: Osteopathic manual therapy

Detailed Description

Non-pharmacological treatment methods, including lifestyle changes, are primarily recommended for the treatment of constipation. In cases where success is not achieved with this method, pharmacological agents, biofeedback and surgical treatment methods can be applied depending on the severity of constipation. Lifestyle changes include increasing fiber and fluid intake and regular physical activity Osteopathic manual therapy (OMT) is the examination and treatment of the function of the neuromusculoskeletal system anatomy using non-invasive, generally safe manual techniques to improve functional body mechanics such as joint range of motion, muscle tone, circulation, body fluid pressures and exchanges, and nerve impulses. OMT is used for autonomic system regulation, balancing pelvic muscle tone, increasing gastrointestinal motility, preventing myofascial limitations and increasing the pump effect of the diaphragm (5,6). The positive effects of OMT on the microbiome are available in the literature.

Alternative treatments are needed because the costs of combating constipation are high. Non-invasive interventions are especially gaining importance.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Pamukkale
    • Denizli, Pamukkale, Turkey (Türkiye), 20000
      • Pamukkale University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Volunteer individuals aged 18 and over
• Clinical diagnosis with functional constipation based on ROMA IV criteria

Exclusion Criteria:

• Clinical diagnosis of a gastrointestinal disease other than constipation,
• Undergone abdominal surgery in the last 6 months,
• Having abdominal aortic aneurysm, acute rectal bleeding, malignant mass in the GIS,
• Pregnancy or suspected of pregnancy,
• Cliniclal diagnosis of neurological disease that may cause constipation,
• Expreinced unexplained fever, Individuals with night sweats and weight loss

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conservative treatment; Nutritional supplements	Dietary supplement: conservative treatment; Nutritional recommendations and necessary nutritional supplements to facilitate digestion and defecation
Experimental: Visceral osteopathy; Osteoaptic manual treatment techniques	Dietary supplement: conservative treatment; Nutritional recommendations and necessary nutritional supplements to facilitate digestion and defecation; Other: Osteopathic manual therapy; Bilateral oscillation therapy to the T10-L2 region for the regulation of sympathetic tone, suboccipital release technique for the regulation of parasympathetic tone, sacrum mobilization, celiac, mesenteric superior and inferior ganglion mobilizations, colon peristalsis and ileocecal valve mobilization for the treatment of functional dysfunctions, ascending colon mobilization, transverse colon mobilization, descending colon fascia mobilization and sigmoid colon mobilization, peritoneal mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constipation severity scale	It is a scale that evaluates individuals' defecation frequency, intensity and difficulty during defecation. The scale includes 16 questions. It has 3 sub-dimensions: fecal obstruction, colon laziness and pain. The score range that can be obtained from the scale is 0-73. high scores indicate symptoms are severe.	5 minutes
Constipation Quality of Life Scale	This scale is a self-rating scale consisting of 28 items and subscales of "anxiety/anxiety" (11 items), "physical discomfort" (4 items), "psychosocial discomfort" (8 items), and "satisfaction" (5 items). Item scores of the five-point Likert-type scale vary between 1 and 5. While patients answered the first and fifth parts of the scale as "Not at all (1)", "Quite a bit (2)", "Somewhat (3)", "Quite a lot (4)" and "A lot (5)", the second, third, In the fourth and sixth sections, he was asked to choose the most suitable one among the options "Never (1)", "Rarely (2)", "Sometimes (3)", "Often (4)", "Always (5)". . The highest score that can be obtained from the scale is 140 and the lowest score is 28. It is thought that as the scores from the scale increase, the quality of life is negatively affected. There should be no unanswered questions for coding to be done.	5 minutes
Bristol Stool Scale	Bristol Stool Scale Bristol Stool Scale classifies human feces into 7 groups. The shape of the stool varies depending on the length of time it stays in the colon. Although not entirely scientific, this chart helps healthcare professionals better perceive stool patterns when making a diagnosis.	5 minutes

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Erhan Kızmaz, PhD, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): May 23, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: December 23, 2023
• First Submitted That Met QC Criteria: December 23, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: osteopathy; Visceral; Functional constipatiton
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Therapeutics; Conservative Treatment
• Other Study ID Numbers: Constipation

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