Visceral Osteopathy in Functional Constipation

Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196073
• Other study ID #: Constipation
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Pamukkale University
• Contact: Erhan Kizmaz, PhD
• Phone: +905418966676
• Email: erhankizmaz[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 30, 2024
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

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

Dietary Supplement:
• conservative treatment
Nutritional recommendations and necessary nutritional supplements to facilitate digestion and defecation

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli	Pamukkale

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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