Constipation Chronic IdiopathicNCT06359249
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
A study testing change of habits and change of habits + auto abdominal massage in people with Constipation Chronic Idiopathic, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation Chronic Idiopathic
- What is being tested?
- change of habits and change of habits + auto abdominal massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 28 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with primary constipation using Rome IV Criteria(11), of more than three months' duration.
- Understanding Catalan, Spanish or English.
Who cannot join
- Having constipation secondary to neurogenic, metabolic, endocrine or postoperative diseases.
- Having constipation secondary to medication for other pathologies, the medication list for which can be found in the annex.
- Having any type of open abdominal and/or anal wound, such as a recent abdominal scar or anal fissure.
- Meeting any absolute contraindication criteria for the use of abdominal massage therapy, such as an unstable fracture requiring absolute rest and immobilisation, pregnancy or active oncological procedures.
- Suffering from some type of cognitive, psychiatric or neurological alteration that does not allow to understand the project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage? A Randomised Control Trial
Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term.
Read the detailed description
Background: Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term.
Method: Randomised clinical trial. Participants: people with constipation in the region of L'Anoia, Catalonia. There will be 3 groups: the control group (CG), behavioural intervention group (BIG) and behavioural intervention and massage group (BIMG). Constipation will be assessed with the Bristol scale, Rome IV Criteria and the number of laxatives; and quality of life with the CVE-20 Questionnaire.
Participants will be proposed from Primary Care Centres in the region of L'Anoia, Catalonia, Spain.
Inclusion criteria:
- Having been diagnosed with primary constipation using Rome IV Criteria(11), of more than three months' duration.
- Understanding Catalan, Spanish or English.
Exclusion criteria:
- Having constipation secondary to neurogenic, metabolic, endocrine or postoperative diseases.
- Having constipation secondary to medication for other pathologies, the medication list for which can be found in the annex.
- Having any type of open abdominal and/or anal wound, such as a recent abdominal scar or anal fissure.
- Meeting any absolute contraindication criteria for the use of abdominal massage therapy, such as an unstable fracture requiring absolute rest and immobilisation, pregnancy or active oncological procedures.
- Suffering from some type of cognitive, psychiatric or neurological alteration that does not allow to understand the project.
Discussion: Research is needed on conservative, non-pharmacological treatment to try to reduce one of the main conditions affecting public health, and thus reduce the possible illnesses associated with constipation and reduce costs to the health system.
- Conditions
- Constipation Chronic Idiopathic
- Being tested
- change of habits, change of habits + auto abdominal massage
- Keywords
- Chronic constipation, abdominal massage, proctologic disease, pelvic floor disorders, physical therapy
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change of habitsBehavioural
change of habits
change of habits + auto abdominal massageOther
change of habits + auto abdominal massage
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Habitual treatment |
| behavioural intervention group | Experimental | Conductual treatment Receives: Behavioral: change of habits |
| behavioural intervention and massage group | Experimental | Conductual and abdominal massage treatment Receives: Other: change of habits + auto abdominal massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of constipation
Degree of constipation with Rome IV Criteria
Measured: Before intervention (Tpre), Day 0, Month 3, Month 6
Stool characteristics
Stool characteristics with the Bristol Scale
Measured: Day 0, Month 3, Month 6
Quality of life focused on patients with constipation
Quality of life focused on patients with constipation with the CVE-20 questionnaire from an emotional, physical and social viewpoint.
Measured: Day 0, Month 3, Month 6
The number of laxatives taken by each participant
The number of laxatives taken by each participant with an accounting schedule.
Measured: Month 3, Month 6
Secondary outcomes (4)
Sex
Male / Female
Measured: Before intervention (Tpre)
Age
Measured in years
Measured: Before intervention (Tpre)
Previous conditions
Baseline characteristics, including the prevalence of relevant comorbidities and cardiovascular risk factors, such as hypertension, diabetes mellitus, smoking status, obesity, and other clinically relevant conditions. The proportion of participants presenting each comorbidity at baseline will be assessed.
Measured: Before intervention (Tpre)
Level of physical activity
Mesured with the VREM questionnaire.
Measured: Day 0, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Mar 2024
- Primary completion28 Dec 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation Chronic IdiopathicStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat de Vic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359249
- Sponsor's protocol ID
- V.3-06/02/2024
- Status last verified
- Sep 2025
- First submitted
- 18 Mar 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage? A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06359249
- Acronym / sponsor ID
- V.3-06/02/2024
- Conditions
- Constipation Chronic Idiopathic
- Keywords
- Chronic constipation, abdominal massage, proctologic disease, pelvic floor disorders, physical therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Universitat de Vic
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 11 Apr 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.
Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term.
Detailed description
Background: Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term.
Method: Randomised clinical trial. Participants: people with constipation in the region of L'Anoia, Catalonia. There will be 3 groups: the control group (CG), behavioural intervention group (BIG) and behavioural intervention and massage group (BIMG). Constipation will be assessed with the Bristol scale, Rome IV Criteria and the number of laxatives; and quality of life with the CVE-20 Questionnaire.
Participants will be proposed from Primary Care Centres in the region of L'Anoia, Catalonia, Spain.
Inclusion criteria:
- Having been diagnosed with primary constipation using Rome IV Criteria(11), of more than three months' duration.
- Understanding Catalan, Spanish or English.
Exclusion criteria:
- Having constipation secondary to neurogenic, metabolic, endocrine or postoperative diseases.
- Having constipation secondary to medication for other pathologies, the medication list for which can be found in the annex.
- Having any type of open abdominal and/or anal wound, such as a recent abdominal scar or anal fissure.
- Meeting any absolute contraindication criteria for the use of abdominal massage therapy, such as an unstable fracture requiring absolute rest and immobilisation, pregnancy or active oncological procedures.
- Suffering from some type of cognitive, psychiatric or neurological alteration that does not allow to understand the project.
Discussion: Research is needed on conservative, non-pharmacological treatment to try to reduce one of the main conditions affecting public health, and thus reduce the possible illnesses associated with constipation and reduce costs to the health system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Habitual treatment |
| behavioural intervention group | Experimental | Behavioral: change of habitsConductual treatment |
| behavioural intervention and massage group | Experimental | Other: change of habits + auto abdominal massageConductual and abdominal massage treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having been diagnosed with primary constipation using Rome IV Criteria(11), of more than three months' duration.
- Understanding Catalan, Spanish or English.
Key exclusion criteria (5 listed)
- Having constipation secondary to neurogenic, metabolic, endocrine or postoperative diseases.
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 |
|---|---|---|
| change of habitschange of habits | Behavioural | behavioural intervention group |
| change of habits + auto abdominal massagechange of habits + auto abdominal massage | Other | behavioural intervention and massage group |
Primary outcome
Degree of constipation
Time frame: Before intervention (Tpre), Day 0, Month 3, Month 6
Degree of constipation with Rome IV Criteria
Stool characteristics
Time frame: Day 0, Month 3, Month 6
Stool characteristics with the Bristol Scale
Quality of life focused on patients with constipation
Time frame: Day 0, Month 3, Month 6
Quality of life focused on patients with constipation with the CVE-20 questionnaire from an emotional, physical and social viewpoint.
The number of laxatives taken by each participant
Time frame: Month 3, Month 6
The number of laxatives taken by each participant with an accounting schedule.
4 secondary outcomes
Sex
Time frame: Before intervention (Tpre)
Age
Time frame: Before intervention (Tpre)
Previous conditions
Time frame: Before intervention (Tpre)
Level of physical activity
Time frame: Day 0, Month 3, Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Constipation Chronic Idiopathic
Active, not 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)
Active, not recruitingObservational study
Post-Marketing Study of Prucalopride Safety In Pregnancy
Chronic Idiopathic Constipation (CIC)
RecruitingPhase 3
A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults
Chronic Idiopathic Constipation (CIC)
RecruitingObservational study
A Study of Prucalopride in Breastfeeding Women With Constipation
Chronic Idiopathic Constipation (CIC)
RecruitingPhase 2/3
Maralixibat in Patients With Cystic Fibrosis and Constipation
Constipation Chronic Idiopathic, Cystic Fibrosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing change of habits and change of habits + auto abdominal massage in people with Constipation Chronic Idiopathic, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Degree of constipation (time frame: Before intervention (Tpre), Day 0, Month 3, Month 6). The study lists 4 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 19 Aug 2026.