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Perineal Self-Acupressure

Primary Purpose

Chronic Constipation, Constipation, Hemorrhoids

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perineal Self-Acupressure
Educational Control
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Chronic constipation, Hemorrhoids, Acupressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Center for East-West Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Perineal Self-Acupressure

Educational Control

Arm Description

Participants in this group (intervention group) will receive education in perineal self-acupressure in addition to education in conventional treatment options for constipation.

Participants in this group (the control group) will receive education in conventional treatment options for chronic constipation.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
SF-12
Questions regarding health related quality of life (HRQOL) from the Short Form (12) Health Survey version 2 questionnaire (SF-12v2).

Full Information

First Posted
May 29, 2013
Last Updated
November 23, 2016
Sponsor
University of California, Los Angeles
Collaborators
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01867944
Brief Title
Perineal Self-Acupressure
Official Title
A Randomized Controlled Trial of Perineal Self-Acupressure for Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation, Constipation, Hemorrhoids
Keywords
Chronic constipation, Hemorrhoids, Acupressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perineal Self-Acupressure
Arm Type
Experimental
Arm Description
Participants in this group (intervention group) will receive education in perineal self-acupressure in addition to education in conventional treatment options for constipation.
Arm Title
Educational Control
Arm Type
Active Comparator
Arm Description
Participants in this group (the control group) will receive education in conventional treatment options for chronic constipation.
Intervention Type
Behavioral
Intervention Name(s)
Perineal Self-Acupressure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Control
Intervention Description
Education on conventional treatment options for chronic constipation.
Primary Outcome Measure Information:
Title
Patient Assessment of Constipation Quality of Life Questionnaire
Description
Constipation related health-related quality of life by means of Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Modified Bowel Function Index and Hemorrhoid Questionnaire
Description
A modified version of the bowel function index for patient self-completion, as well as original questions to measure change in hemorrhoid impact
Time Frame
1 month
Title
SF-12
Description
Questions regarding health related quality of life (HRQOL) from the Short Form (12) Health Survey version 2 questionnaire (SF-12v2).
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Technique and Educational Material Effectiveness
Description
Unique questions regarding use of and effectiveness of technique and educational materials.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan B Abbott, MD, JD, MTOM
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for East-West Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25403522
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.
Results Reference
result

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Perineal Self-Acupressure

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