Functional ConstipationNCT06196073
Visceral Osteopathy in Functional Constipation
A study testing Osteopathic manual therapy and conservative treatment in people with Functional Constipation, run by Pamukkale University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Osteopathic manual therapy and conservative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer individuals aged 18 and over
- Clinical diagnosis with functional constipation based on ROMA IV criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20000
About this study
Official title: The Effectiveness of Visceral Osteopathy in Functional Constipation: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Functional Constipation
- Being tested
- Osteopathic manual therapy, conservative treatment
- Keywords
- Functional constipatiton, Visceral, osteopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manual therapyOther
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 treatmentDietary supplement
Nutritional recommendations and necessary nutritional supplements to facilitate digestion and defecation
| Study group | Role | What they receive |
|---|---|---|
| Visceral osteopathy | Experimental | Osteoaptic manual treatment techniques Receives: Other: Osteopathic manual therapy; Dietary Supplement: conservative treatment |
| conservative treatment | Experimental | Nutritional supplements Receives: Dietary Supplement: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Oct 2023
- Primary completion23 May 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel two group which are equal
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan KIZMAZ, Pamukkale University
- Investigators
- Erhan Kızmaz, PhD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196073
- Sponsor's protocol ID
- Constipation
- Status last verified
- May 2026
- First submitted
- 23 Dec 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Visceral Osteopathy in Functional Constipation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06196073
- Acronym / sponsor ID
- Constipation
- Conditions
- Functional Constipation
- Keywords
- Functional constipatiton, Visceral, osteopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel two group which are equal
| Arm | Type | Receives |
|---|---|---|
| Visceral osteopathy | Experimental | Other: Osteopathic manual therapy, Dietary Supplement: conservative treatmentOsteoaptic manual treatment techniques |
| conservative treatment | Experimental | Dietary Supplement: conservative treatmentNutritional supplements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteer individuals aged 18 and over
- Clinical diagnosis with functional constipation based on ROMA IV criteria
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic manual therapyBilateral 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 | Other | Visceral osteopathy |
| conservative treatmentNutritional recommendations and necessary nutritional supplements to facilitate digestion and defecation | Dietary supplement | Visceral osteopathy, conservative treatment |
Primary outcome
Constipation severity scale
Time frame: 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.
Constipation Quality of Life Scale
Time frame: 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.
Bristol Stool Scale
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
Related trials for Functional Constipation
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Recruiting
Core-Based Movement and Nutritional Counselling for Stress and Metabolic Outcomes in Overweight Women With Functional Constipation
Functional Constipation
Active, not recruiting
The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
Constipation, Constipation - Functional
Recruiting
Fiber Nutritional Supplement for Management of Constipation During Pregnancy
Functional Constipation (FC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhan Kızmaz, PhD principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manual therapy and conservative treatment in people with Functional Constipation, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation severity scale (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.