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

NCT06359249 | Active Not Recruiting DMC

• 1 other identifier: V.3-06/02/2024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation Chronic Idiopathic

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Other patient characteristics such as sex, age, previous conditions, and level of physical activity with the VREM questionnaire.

  Day 0, Month 3, Month 6

Study Arms (3)

Control group

NO INTERVENTION

Habitual treatment

behavioural intervention group

EXPERIMENTAL

Conductual treatment

Behavioral: change of habits

behavioural intervention and massage group

EXPERIMENTAL

Conductual and abdominal massage treatment

Other: change of habits + auto abdominal massage

Interventions

change of habits BEHAVIORAL

change of habits

behavioural intervention group

change of habits + auto abdominal massage OTHER

change of habits + auto abdominal massage

behavioural intervention and massage group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having been diagnosed with primary constipation using Rome IV Criteria(11), of more than three months' duration.
• Understanding Catalan, Spanish or English.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cristina Segura Bayona

Igualada, Barcelona, 08700, Spain

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 11, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)