Clinical trial NCT06196073: Visceral Osteopathy in Functional Constipation
Official title: The Effectiveness of Visceral Osteopathy in Functional Constipation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Constipation
Keywords: Functional constipatiton
Visceral
osteopathy
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel two group which are equal
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Constipation severity scale
timeFrame: 5 minutes
measure: Constipation Quality of Life Scale
timeFrame: 5 minutes
measure: Bristol Stool Scale
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Pamukkale
Study officials:
affiliation: Pamukkale University
name: Erhan Kızmaz, PhD
role: PRINCIPAL_INVESTIGATOR
References: