NCT06695754

Brief Summary

The aim of this study is to do a systematic review and metanalysis of the scientific literature to compare the effectiveness of the manual vs the automatic colonic massage intervention in patients with chronic constipation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

December 18, 2024

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

5 days

First QC Date

November 13, 2024

Last Update Submit

January 20, 2026

Conditions

Keywords

manual massageautomatic massagecolonic massageintermittent colonic exoperistalsis

Outcome Measures

Primary Outcomes (1)

  • Quantitative evaluation of manual vs. automatic colon massage for chronic constipation relief

    Quantitative comparison of manual and automatic colon massage efficacy in relieving chronic constipation

    34 years

Secondary Outcomes (4)

  • Evacuation frequency

    34 years

  • Quality of life questionnaire in relation to constipation

    34 years

  • Adverse events

    34 years

  • Aids to evacuation

    34 years

Study Arms (3)

Manual massage <90% over colon

Patients received a manual massage or treatment that reachs the ascending and descending colon for less than 90% of the total time of the treatment duration

Manual massage >90% over colon

Patients received a manual massage or treatment that reachs the ascending and descending colon for 90% or more of the total time of treatment duration

Automatic massage

Patients received a massage or treatment delivered with a medical device, that reachs the ascending and descending colon for 90% or more of the total time of treatment duration

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of any age, gender and etnicity, suffering from chronic constipation

You may qualify if:

  • Study type:
  • Clinical studies using abdominal/colon massage to treat constipation.
  • Articles published between 1990 and till the day of literature search with original work (experimental and quasi-experimental ) or dealing with the application of colon massage to gastrointestinal function.
  • Study subjects:
  • Patients with constipation.
  • Individuals of any gender, age and ethnicity.
  • Interventions:
  • \- Manual or automatic colon massage treatment for constipation.
  • Outcomes (including at least one of the following):
  • Evacuation frequency.
  • Quality of life parameters.
  • Symptoms of constipation.
  • Use of laxatives or enemas.
  • Adverse events.

You may not qualify if:

  • No abstract available, reviews, conference abstracts, dissertations, registration documents, clinical experience summary analysis, animal experiments, etc.
  • Studies where the treatment was non-colon specific.
  • Studies involving invasive treatments.
  • Other treatments intended to treat constipation such as surgical interventions, acupuncture, acupoint application, and others considered medicinal alternative therapies.
  • Documents written in languages other than in English, German, Spanish, as well as other European languages, including Italian, French, and Portuguese.
  • Incorrect or incomplete case data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usmima S.L.

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Study Officials

  • Immaculada Herrero-Fresneda, PhD

    usMIMA S.L.

    STUDY DIRECTOR
  • Eugenia Delgado, PhD

    usMIMA S.L.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 19, 2024

Study Start

December 18, 2024

Primary Completion

December 23, 2024

Study Completion

December 31, 2024

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations