Clinical trial NCT01867944: Perineal Self-Acupressure
Official title: A Randomized Controlled Trial of Perineal Self-Acupressure for Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Constipation
Constipation
Hemorrhoids
Keywords: Chronic constipation
Hemorrhoids
Acupressure
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2013-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Patient Assessment of Constipation Quality of Life Questionnaire
timeFrame: 1 month
Secondary outcomes:
measure: Modified Bowel Function Index and Hemorrhoid Questionnaire
timeFrame: 1 month
measure: SF-12
timeFrame: 1 month
Other outcomes:
measure: Technique and Educational Material Effectiveness
timeFrame: 1 month
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for East-West Medicine
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Ryan B Abbott, MD, JD, MTOM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Epub 2014 Nov 18.