Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06359249 |
| Other study ID # |
V.3-06/02/2024 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2024 |
| Est. completion date |
December 28, 2026 |
Study information
| Verified date |
March 2024 |
| Source |
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
