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|ClinicalTrials.gov Identifier: NCT01867944|
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : November 28, 2016
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 or disease||Intervention/treatment||Phase|
|Chronic Constipation Constipation Hemorrhoids||Behavioral: Perineal Self-Acupressure Behavioral: Educational Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Perineal Self-Acupressure for Chronic Constipation|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 2014|
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.
- 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).
- 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
- 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).
- Technique and Educational Material Effectiveness [ Time Frame: 1 month ]Unique questions regarding use of and effectiveness of technique and educational materials.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867944
|United States, California|
|UCLA Center for East-West Medicine|
|Los Angeles, California, United States, 90024|
|Principal Investigator:||Ryan B Abbott, MD, JD, MTOM||University of California, Los Angeles|