A Randomized Controlled Trial of Perineal Self-Acupressure for Chronic Constipation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Patient Assessment of Constipation Quality of Life Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Modified Bowel Function Index and Hemorrhoid Questionnaire(1 month)
- SF-12(1 month)