Perineal Self-Acupressure

November 23, 2016 updated by: University of California, Los Angeles

A Randomized Controlled Trial of Perineal Self-Acupressure for Chronic Constipation

The primary aim of this study is to test a non-medicinal technique for chronic constipation. The core of the technique is to have subjects repeatedly press on and massage their perineum before defecation to fragment and soften the stool before it passes the lower rectum and anus. The technique will be evaluated as a complementary treatment to standard treatment of constipation (patient educational materials about treatments such as stool softeners, laxatives fiber supplements, and increased exercise). Although this technique has been studied for other conditions (for example in pregnant women to prevent birthing-related injuries), and it is recommended anecdotally by some physicians, this would be the first time it will be studied for chronic constipation in a randomized, controlled clinical trial.

$50 dollars in compensation is provided for about an hour of participant's time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA Center for East-West Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have experienced the following symptoms for at least three months:

    • Straining during at least 25 percent of defecations
    • Lumpy or hard stools in at least 25 percent of defecations
    • Sensation of incomplete evacuation for at least 25 percent of defecations
    • Sensation of anorectal obstruction/blockage for at least 25 percent of defecations
    • Manual maneuvers to facilitate at least 25 percent of defecations (eg, digital evacuation, support of the pelvic floor)
    • Fewer than three defecations per week
  • Must have experienced one or more of those symptoms at least six months ago.

Exclusion Criteria:

  • Younger than 18 years old.
  • Pregnant women.
  • Significant weight loss (more than 10% of usual body weight in the preceding 6 months).
  • History of blood mixed in stool.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Perineal Self-Acupressure
Participants in this group (intervention group) will receive education in perineal self-acupressure in addition to education in conventional treatment options for constipation.
Behavioral: Perineal Self-Acupressure
The core of the technique is to have subjects repeatedly press on and massage their perineum before defecation to fragment and soften the stool before it passes the lower rectum and anus.
ACTIVE_COMPARATOR: Educational Control
Participants in this group (the control group) will receive education in conventional treatment options for chronic constipation.
Behavioral: Educational Control
Education on conventional treatment options for chronic constipation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Assessment of Constipation Quality of Life Questionnaire
Time Frame: 1 month
Constipation related health-related quality of life by means of Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL).
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Bowel Function Index and Hemorrhoid Questionnaire
Time Frame: 1 month
A modified version of the bowel function index for patient self-completion, as well as original questions to measure change in hemorrhoid impact
1 month
SF-12
Time Frame: 1 month
Questions regarding health related quality of life (HRQOL) from the Short Form (12) Health Survey version 2 questionnaire (SF-12v2).
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technique and Educational Material Effectiveness
Time Frame: 1 month
Unique questions regarding use of and effectiveness of technique and educational materials.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Yale University

Investigators

  • Principal Investigator: Ryan B Abbott, MD, JD, MTOM, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 29, 2013

First Posted (ESTIMATE)

June 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-000738

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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