Visceral Osteopathy in Functional Constipation

NCT ID: NCT06196073

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel two group which are equal
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Sealed envelope method

Study Groups

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Visceral osteopathy and conservative treatment

Osteoaptic manual treatment techniques

Group Type EXPERIMENTAL

Osteopathic manual therapy

Intervention Type 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

conservative treatment

Intervention Type DIETARY_SUPPLEMENT

Nutritional recommendations and necessary nutritional supplements to facilitate digestion and defecation

conservative treatment

Nutritional supplements

Group Type EXPERIMENTAL

conservative treatment

Intervention Type DIETARY_SUPPLEMENT

Nutritional recommendations and necessary nutritional supplements to facilitate digestion and defecation

Interventions

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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

Intervention Type OTHER

conservative treatment

Nutritional recommendations and necessary nutritional supplements to facilitate digestion and defecation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Erhan KIZMAZ

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erhan Kızmaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

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Pamukkale University

Denizli, Pamukkale, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Erhan Kızmaz, PhD

Role: CONTACT

+905418966676

Aziz Dengiz, PhD

Role: CONTACT

+905454216688

Facility Contacts

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Erhan Kızmaz, PhD

Role: primary

+905418966676

Other Identifiers

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Constipation

Identifier Type: -

Identifier Source: org_study_id

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