Visceral Osteopathy in Functional Constipation

Not Applicable

Recruiting

• Conditions: Functional Constipation
• Interventions: Other: Osteopathic manual therapy; Dietary Supplement: conservative treatment

• Registration Number: NCT06196073
• Lead Sponsor: Pamukkale University

Brief Summary

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.

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 Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-12-23
• Study First Submitted QC: 2023-12-23
• Study First Posted: 2024-01-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-05-23
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visceral osteopathy and conservative treatment	Osteopathic manual therapy	Osteoaptic manual treatment techniques
conservative treatment	conservative treatment	Nutritional supplements
Visceral osteopathy and conservative treatment	conservative treatment	Osteoaptic manual treatment techniques

Primary Outcome Measures

Name	Time	Method
Constipation severity scale	5 minutes	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.
Bristol Stool Scale	5 minutes	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.
Constipation Quality of Life Scale	5 minutes	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.

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Pamukkale, Turkey