Chronic ConstipationNCT01867944
Perineal Self-Acupressure
A study testing Perineal Self-Acupressure in people with Chronic Constipation and Constipation, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Constipation, Constipation, Hemorrhoids
- What is being tested?
- Perineal Self-Acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for East-West Medicine
Los Angeles, California, 90024
About this study
Official title: A Randomized Controlled Trial of Perineal Self-Acupressure for Chronic Constipation
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.
- Conditions
- Chronic Constipation, Constipation, Hemorrhoids
- Being tested
- Perineal Self-Acupressure, Educational Control
- Keywords
- Chronic constipation, Hemorrhoids, Acupressure
- Medical subject headings
- Constipation, Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal Self-AcupressureBehavioural
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 ControlBehavioural
Education on conventional treatment options for chronic constipation.
| Study group | Role | What they receive |
|---|---|---|
| Perineal Self-Acupressure | Experimental | Participants in this group (intervention group) will receive education in perineal self-acupressure in addition to education in conventional treatment options for constipation. Receives: Behavioral: Perineal Self-Acupressure |
| Educational Control | Active comparator | Participants in this group (the control group) will receive education in conventional treatment options for chronic constipation. Receives: Behavioral: Educational Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Secondary outcomes (2)
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
Measured: 1 month
SF-12
Questions regarding health related quality of life (HRQOL) from the Short Form (12) Health Survey version 2 questionnaire (SF-12v2).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Ryan B Abbott, MD, JD, MTOM, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867944
- Sponsor's protocol ID
- 13-000738
- Status last verified
- Nov 2016
- First submitted
- 29 May 2013
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25403522
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Perineal Self-Acupressure for Chronic Constipation
- ClinicalTrials.gov ID
- NCT01867944
- Acronym / sponsor ID
- 13-000738
- Conditions
- Chronic Constipation, Constipation, Hemorrhoids
- Keywords
- Chronic constipation, Hemorrhoids, Acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineal Self-Acupressure | Experimental | Behavioral: Perineal Self-AcupressureParticipants in this group (intervention group) will receive education in perineal self-acupressure in addition to education in conventional treatment options for constipation. |
| Educational Control | Active comparator | Behavioral: Educational ControlParticipants in this group (the control group) will receive education in conventional treatment options for chronic constipation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must have experienced the following symptoms for at least three months:
- Must have experienced one or more of those symptoms at least six months ago.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal Self-AcupressureThe 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. | Behavioural | Perineal Self-Acupressure |
| Educational ControlEducation on conventional treatment options for chronic constipation. | Behavioural | Educational Control |
Primary outcome
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).
2 secondary outcomes
Modified Bowel Function Index and Hemorrhoid Questionnaire
Time frame: 1 month
SF-12
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Results publication: PubMed 25403522Abbott 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.
Related trials for Chronic Constipation
RecruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
Active, not recruiting
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Constipation Chronic Idiopathic
RecruitingPhase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Constipation
Active, not recruitingObservational study
Post-Marketing Study of Prucalopride Safety In Pregnancy
Chronic Idiopathic Constipation (CIC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan B Abbott, MD, JD, MTOM principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal Self-Acupressure in people with Chronic Constipation and Constipation, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Assessment of Constipation Quality of Life Questionnaire (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01867944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.