Perineal Self-Acupressure

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867944
• Other study ID #: 13-000738
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: November 23, 2016
• Start date: June 2013

Study information

• Verified date: November 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation
• Hemorrhoids

Intervention

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.
• Educational Control
Education on conventional treatment options for chronic constipation.

Locations

Country	Name	City	State
United States	UCLA Center for East-West Medicine	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Yale University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Technique and Educational Material Effectiveness	Unique questions regarding use of and effectiveness of technique and educational materials.	1 month	No
Primary	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	No
Secondary	Modified Bowel Function Index and Hemorrhoid Questionnaire	A modified version of the bowel function index for patient self-completion, as well as original questions to measure change in hemorrhoid impact	1 month	No
Secondary	SF-12	Questions regarding health related quality of life (HRQOL) from the Short Form (12) Health Survey version 2 questionnaire (SF-12v2).	1 month	No