Clinical trial NCT06359249: Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Constipation Chronic Idiopathic
Keywords: Chronic constipation
abdominal massage
proctologic disease
pelvic floor disorders
physical therapy
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Universitat de Vic
First posted: 2024-04-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Degree of constipation
timeFrame: Day 0, Month 3, Month 6
measure: Stool characteristics
timeFrame: Day 0, Month 3, Month 6
measure: Quality of life focused on patients with constipation
timeFrame: Day 0, Month 3, Month 6
measure: The number of laxatives taken by each participant
timeFrame: Month 3, Month 6
Secondary outcomes:
measure: Other patient characteristics such as sex, age, previous conditions, and level of physical activity with the VREM questionnaire.
timeFrame: Day 0, Month 3, Month 6
Other outcomes:
Locations:
city: Igualada
country: Spain
facility: Cristina Segura Bayona
state: Barcelona
Study officials:
References: