Perineal Self-Acupressure

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Ryan Abbott, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01867944
First received: May 29, 2013
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Chronic Constipation
Constipation
Hemorrhoids
Behavioral: Perineal Self-Acupressure
Behavioral: Educational Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Perineal Self-Acupressure for Chronic Constipation

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Patient Assessment of Constipation Quality of Life Questionnaire [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Constipation related health-related quality of life by means of Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL).


Secondary Outcome Measures:
  • Modified Bowel Function Index and Hemorrhoid Questionnaire [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Questions regarding health related quality of life (HRQOL) from the Short Form (12) Health Survey version 2 questionnaire (SF-12v2).


Other Outcome Measures:
  • Technique and Educational Material Effectiveness [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Unique questions regarding use of and effectiveness of technique and educational materials.


Enrollment: 100
Study Start Date: June 2013
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867944

Locations
United States, California
UCLA Center for East-West Medicine
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Yale University
Investigators
Principal Investigator: Ryan B Abbott, MD, JD, MTOM University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Ryan Abbott, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01867944     History of Changes
Other Study ID Numbers: 13-000738
Study First Received: May 29, 2013
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Chronic constipation
Hemorrhoids
Acupressure

Additional relevant MeSH terms:
Constipation
Hemorrhoids
Signs and Symptoms, Digestive
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014