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Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?

Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage? A Randomised Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06359249
Enrollment
45
Registered
2024-04-11
Start date
2024-03-01
Completion date
2026-12-28
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation Chronic Idiopathic

Keywords

Chronic constipation, abdominal massage, proctologic disease, pelvic floor disorders, physical therapy

Brief 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 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.

Interventions

BEHAVIORALchange of habits

change of habits

OTHERchange of habits + auto abdominal massage

change of habits + auto abdominal massage

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER
Universitat de Vic
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Degree of constipationBefore intervention (Tpre), Day 0, Month 3, Month 6Degree of constipation with Rome IV Criteria
Stool characteristicsDay 0, Month 3, Month 6Stool characteristics with the Bristol Scale
Quality of life focused on patients with constipationDay 0, Month 3, Month 6Quality 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 participantMonth 3, Month 6The number of laxatives taken by each participant with an accounting schedule.

Secondary

MeasureTime frameDescription
SexBefore intervention (Tpre)Male / Female
AgeBefore intervention (Tpre)Measured in years
Previous conditionsBefore intervention (Tpre)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.
Level of physical activityDay 0, Month 3, Month 6Mesured with the VREM questionnaire.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026