Perineal Self-Acupressure

NCT ID: NCT01867944

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Constipation Constipation Hemorrhoids

Keywords

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Chronic constipation Hemorrhoids Acupressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Perineal Self-Acupressure

Intervention Type BEHAVIORAL

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.

Educational Control

Participants in this group (the control group) will receive education in conventional treatment options for chronic constipation.

Group Type ACTIVE_COMPARATOR

Educational Control

Intervention Type BEHAVIORAL

Education on conventional treatment options for chronic constipation.

Interventions

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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.

Intervention Type BEHAVIORAL

Educational Control

Education on conventional treatment options for chronic constipation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan B Abbott, MD, JD, MTOM

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA Center for East-West Medicine

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Abbott R, Ayres I, Hui E, Hui KK. Effect of perineal self-acupressure on constipation: a randomized controlled trial. J Gen Intern Med. 2015 Apr;30(4):434-9. doi: 10.1007/s11606-014-3084-6. Epub 2014 Nov 18.

Reference Type RESULT
PMID: 25403522 (View on PubMed)

Other Identifiers

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13-000738

Identifier Type: -

Identifier Source: org_study_id