NCT01867944

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

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

May 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

May 29, 2013

Last Update Submit

November 23, 2016

Conditions

Chronic ConstipationConstipationHemorrhoids

Keywords

Chronic constipationHemorrhoidsAcupressure

Outcome Measures

Primary Outcomes (1)

  • Patient Assessment of Constipation Quality of Life Questionnaire

    Constipation related health-related quality of life by means of Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL).

    1 month

Secondary Outcomes (2)

  • Modified Bowel Function Index and Hemorrhoid Questionnaire

    1 month

  • SF-12

    1 month

Other Outcomes (1)

  • Technique and Educational Material Effectiveness

    1 month

Study Arms (2)

Perineal Self-Acupressure

EXPERIMENTAL

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

Educational Control

ACTIVE COMPARATOR

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

Behavioral: Educational Control

Interventions

Perineal Self-AcupressureBEHAVIORAL

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.

Perineal Self-Acupressure
Educational ControlBEHAVIORAL

Education on conventional treatment options for chronic constipation.

Educational Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Center for East-West Medicine

Los Angeles, California, 90024, United States

Location

Related Publications (1)

  • 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.

    PMID: 25403522RESULT

MeSH Terms

Conditions

ConstipationHemorrhoids

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ryan B Abbott, MD, JD, MTOM

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 4, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

US(1)