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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Constipation Chronic Idiopathic
• Intervention / Treatment: Behavioral: change of habits; Other: change of habits + auto abdominal massage

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Igualada, Barcelona, Spain, 08700
      • Cristina Segura Bayona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Habitual treatment
Experimental: behavioural intervention group; Conductual treatment	Behavioral: change of habits; change of habits
Experimental: behavioural intervention and massage group; Conductual and abdominal massage treatment	Other: change of habits + auto abdominal massage; change of habits + auto abdominal massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of constipation	Degree of constipation with Rome IV Criteria	Day 0, Month 3, Month 6
Stool characteristics	Stool characteristics with the Bristol Scale	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.	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.	Month 3, Month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Other patient characteristics such as sex, age, previous conditions, and level of physical activity with the VREM questionnaire.	Day 0, Month 3, Month 6

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Universitat de Vic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 28, 2026

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pelvic floor disorders; physical therapy; abdominal massage; Chronic constipation; proctologic disease
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: V.3-06/02/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No