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Completed

NCT Number: NCT01867944

Perineal Self-Acupressure

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.

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Key information

Conditions

Chronic Constipation Cardiovascular Diseases Constipation Digestive System Diseases Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Center for East-West Medicine

Los Angeles, California, 90024, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perineal Self-Acupressure

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

Behavioral

Education on conventional treatment options for chronic constipation.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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).

Other outcomes

  1. Technique and Educational Material Effectiveness

    Time frame: 1 month

    Unique questions regarding use of and effectiveness of technique and educational materials.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Yale University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
First posted
Jun 4, 2013
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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