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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Active, not recruiting

Conditions: Constipation Chronic Idiopathic

Treatments: Behavioral: change of habits; Other: change of habits + auto abdominal massage

Study type: Interventional

Funder types: Other

Identifiers

NCT06359249

V.3-06/02/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Control group

No Intervention group

Description:

Habitual treatment

behavioural intervention group

Experimental group

Description:

Conductual treatment

Treatment:

Behavioral: change of habits

behavioural intervention and massage group

Experimental group

Description:

Conductual and abdominal massage treatment

Treatment:

Other: change of habits + auto abdominal massage