Visceral Osteopathy in Functional Constipation

NCT06196073 | Recruiting

• 1 other identifier: Constipation
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Constipation

Keywords

Functional constipatiton; Visceral; osteopathy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Visceral osteopathy and conservative treatment

EXPERIMENTAL

Osteoaptic manual treatment techniques

Other: Osteopathic manual therapy; Dietary Supplement: conservative treatment

conservative treatment

EXPERIMENTAL

Nutritional supplements

Dietary Supplement: conservative treatment

Interventions

Osteopathic manual therapy OTHER

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

Visceral osteopathy and conservative treatment

conservative treatment DIETARY_SUPPLEMENT

Nutritional recommendations and necessary nutritional supplements to facilitate digestion and defecation

Visceral osteopathy and conservative treatment; conservative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Erhan Kızmaz, PhD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erhan Kızmaz, PhD

CONTACT

+905418966676; erhankizmaz@hotmail.com

Aziz Dengiz, PhD

CONTACT

+905454216688; ptazizdengiz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Sealed envelope method
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Parallel two group which are equal

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 9, 2024
• Study Start: October 1, 2023
• Primary Completion: May 23, 2024
• Study Completion: June 30, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)