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CompletedNCT06695754COMACOMACCUpdated Jan 21, 2026

Comparing Manual and Automatic Colonic Massage for Chronic Constipation.

An observational study in Chronic Constipation, sponsored by usMIMA S.L.. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by usMIMA S.L. · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
2,312
Sex
All
01

Study 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.

Read the detailed description

Retrieval Strategy

  • Computer retrieval of clinical literature on abdominal massage for constipation published between 1990 and December 2024 will be conducted in:

    • NCBI PubMed.
    • Research Gate.
    • Google Scholar.
    • Ovid.
  • English retrieval terms included: colon, abdominal, constipation, bowel function, transit time, massage, and device.
  • A cross-retrieval will be conducted to screen the literature that met the inclusion criteria.

Literature screening and data extraction

  • The literature search will be independently performed by two researchers.
  • Identified studies will be imported into EndNote×9 and Mendeley for organization.
  • Articles will be evaluated based on predefined inclusion and exclusion criteria.
  • Duplicates from various databases will be removed.
  • Clearly irrelevant articles will be excluded based on their titles and abstracts.
  • Full texts of the remaining studies will be thoroughly reviewed, and those that met the criteria will be included.
  • The final dataset will be cross-verified.
  • Discrepancies will be resolved through discussion or by involving a third researcher with a PhD for arbitration.

  • Extracted data included:

    • First author's name
    • Publication year
    • Study type
    • Sample size
    • Participant gender and age
    • Interventions in both experimental and control groups
    • Treatment duration and frequency
    • Primary and secondary study outcomes
    • Quality assessment of the studies
  • Study characteristics, along with the study design, description of interventions (type of colon massage applied), and indices of evaluated results, will be organized using an Excel-based data extraction form.

Quality evaluation

  • Quality assessment of the literature will be conducted using the "risk of bias" tool recommended by the Cochrane Handbook for Systematic Reviews (Rob2.0 and Robins-E). These tools evaluate various bias domains, including randomization, deviations from intended interventions, missing data, outcome measurement, and selective reporting. Each domain will be rated as having a high, unclear, or low risk of bias.
  • Disagreements between the two researchers regarding the literature's conclusions will be resolved through discussion or by a third researcher.
02

Conditions studied

  • Chronic Constipation

Keywords

  • manual massage
  • automatic massage
  • colonic massage
  • intermittent colonic exoperistalsis
03

In context

Lead sponsor

usMIMA S.L. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

Literature Inclusion Criteria:

  • 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.

Literature Exclusion Criteria:

  • 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.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
2,312 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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

    Time frame: 34 years

Secondary outcomes

  1. Evacuation frequency

    Number of bowel movementes per week

    Time frame: 34 years

  2. Quality of life questionnaire in relation to constipation

    Semi-Quantitative score derived from standardized qualitative questionnaires evaluating quality of life in relation to chronic constipation.

    Time frame: 34 years

  3. Adverse events

    Any secondary adverse effect directly derived from the treatment, including Serious Adverse Events (SAE)

    Time frame: 34 years

  4. Aids to evacuation

    Use (total number of days in use or total dose per week) of any aid to facilitate evacuation such as laxatives, enemas, digitation....

    Time frame: 34 years

07

Study locations

1 site
  • Usmima S.L.
    Esplugues de Llobregat, Barcelona 08950, Spain
08

References and documents

Publications

  • Delgado ME, Benet J, Herrero-Fresneda I. Safety and Efficacy of Manual and Automated Abdominal Colonic Massage for Chronic Constipation: A Systematic Review and Meta-Analysis. Clin Transl Gastroenterol. 2026 Jul 1;17(7):e01027. doi: 10.14309/ctg.0000000000001027. Epub 2026 Apr 1. PubMed 41919979 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06695754
Lead sponsor
usMIMA S.L.
Responsible party
Sponsor
First posted
Nov 19, 2024
Start date
Dec 18, 2024
Primary completion
Dec 23, 2024
Completion
Dec 31, 2024
Last update
Jan 21, 2026

Study contacts

Immaculada Herrero-Fresneda, PhD
study director · usMIMA S.L.
Eugenia Delgado, PhD
principal investigator · usMIMA S.L.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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