Perineal Self-Acupressure

Not Applicable

Completed

• Conditions: Chronic Constipation; Hemorrhoids; Constipation
• Interventions: Behavioral: Perineal Self-Acupressure; Behavioral: Educational Control

• Registration Number: NCT01867944
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-29
• Study Start: 2013-06
• Study First Posted: 2013-06-04
• Primary Completion: 2014-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perineal Self-Acupressure	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.
Educational Control	Educational Control	Participants in this group (the control group) will receive education in conventional treatment options for chronic constipation.

Primary Outcome Measures

Name	Time	Method
Patient Assessment of Constipation Quality of Life Questionnaire	1 month	Constipation related health-related quality of life by means of Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL).

Secondary Outcome Measures

Name	Time	Method
Modified Bowel Function Index and Hemorrhoid Questionnaire	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
SF-12	1 month	Questions regarding health related quality of life (HRQOL) from the Short Form (12) Health Survey version 2 questionnaire (SF-12v2).

Trial Locations

Locations (1)

UCLA Center for East-West Medicine; 🇺🇸 Los Angeles, California, United States