Chronic ConstipationPhase 2NCT01599156
Reflexology for Chronic Constipation
A Phase 2 study testing Reflexology in people with Chronic Constipation, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine if the use of reflexology can alleviate chronic constipation. The trial will last 26 week per patient, 2 week of screening period, 12 weeks of treatment and 12 weeks of follow up. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Reflexology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Apr 2013
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18-55 years
- Fewer than three SBMs per week (occurring without the use of a laxative, enema, or suppository within the preceding 24 hours)
- One or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months:(1)straining, lumpy or (2) hard stools, and (3)a sensation of incomplete evacuation Six or fewer SBMs/week and fewer than three complete CSBMs/week during the 14-day baseline period.
- Ability to comply with the study guidelines
Who cannot join
- Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials.
- Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period.
- Rome III criteria for the irritable bowel syndrome.
- History of pelvic-floor dysfunction.
- Neurological pathologies
- Psychiatric conditions
- Chronic use of medication with a GI-activity.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
Jerusalem
Menachem Oberbaum, MD, +972-2-6666395, oberbaum@szmc.org.il
Menachem Oberbaum, MD
About this study
Official title: Reflexology for Patients Suffering From Chronic Constipation- a Phase II B, Single Armed, Open Label Study.
The purpose of this study is to examine if the use of reflexology can alleviate chronic constipation. The trial will last 26 week per patient, 2 week of screening period, 12 weeks of treatment and 12 weeks of follow up. Included in the study will be 40 men and women, 18 years of age or older, which are able to comply with the study guidelines; Fewer than three spontaneous bowel movement per week; and one or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months: (1) straining, lumpy or (2) hard stools, and (3) a sensation of incomplete evacuation. Exclusion criteria are: Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials; Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period; Rome III criteria for the irritable bowel syndrome; History of pelvic-floor dysfunction; Neurological pathologies; Psychiatric conditions; Chronic use of medication with a gastro intestinal-activity.
- Conditions
- Chronic Constipation
- Being tested
- Reflexology
- Keywords
- Chronic constipation, Reflexology, Complementary medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyProcedure or surgery
Reflexology is a therapy whereby diagnosis and treatment are done on the patient's feet. According to reflexology, our feet are a micro-cosmos of our bodies and contain all the body's systems and internal organs. The treatment is palpation and massage of specific reflex points that respond to the body organs. This massage or palpitation of reflex points improves the physical function of the corresponding organ or system
| Study group | Role | What they receive |
|---|---|---|
| Reflexology | Experimental | reflexology treatment, x2-3/week for 12 weeks Receives: Procedure: Reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks
Will be assessed daily during the 24 weeks of the study
Measured: 24 weeks
Increase of at least one CSBM per week from baseline for 9 or more weeks during the 24-week treatment period
Will be assessed weekly during the 24 weeks of the study
Measured: 24 weeks
Secondary outcomes (10)
Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs)
Will be assessed weekly during the 24 weeks of the study
Measured: 24 weeks
Stool consistency/week using the 7- point Bristol Stool Form Scale, during the 24 weeks of the study period
Will be assessed weekly during the 24 weeks of the study
Measured: 24 weeks
Severity of straining using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount).
Will be assessed daily during the 24 weeks of the study
Measured: 24 weeks
Abdominal discomfort, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)
Will be assessed daily during the 24 weeks of the study
Measured: 24 weeks
Severity of bloating, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)
Will be assessed daily during the 24 weeks of the study
Measured: 24 weeks
Constipation severity (using a 5-point ordinal scale, with higher scores indicating greater severity)
Will be assessed weekly during the 24 weeks of the study
Measured: 24 weeks
Constipation relief (based on a 7-point balanced scale, with 1 indicating complete relief, 4 indicating no change, and 7 indicating very severe constipation)
Will be assessed weekly during the 24 weeks of the study
Measured: 24 weeks
Satisfaction with the trial results, using a 5-point ordinal scale
will be assessed at the 12-week visit and at the 24-week visit (at the study end)
Measured: 24 weeks
Health related quality of life (using the validated Patient Assessment of Constipation Quality of Life instrument (PAC-QOL)
will be assessed at baseline; at the 12-week visit and at the 24-week visit (at the study end)
Measured: 24 weeks
Treatment side effects
Will be assessed at baseline, week 12 and week 24 (trial end)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Menachem Oberbaum, MD, Principal investigator, Menachem Oberbaum, MD, Phone:+972-2-6666395, Email: oberbaum@szmc.org.ilJoseph Lysy, Principal investigator, Joseph Lysy,Phone: +972-2-6666116 Email: lysyj@szmc.org.il
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599156
- Sponsor's protocol ID
- REF11
- Status last verified
- Jul 2012
- First submitted
- 6 May 2012
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflexology for Patients Suffering From Chronic Constipation- a Phase II B, Single Armed, Open Label Study.
- ClinicalTrials.gov ID
- NCT01599156
- Acronym / sponsor ID
- REF11
- Conditions
- Chronic Constipation
- Keywords
- Chronic constipation, Reflexology, Complementary medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 15 May 2012 (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 purpose of this study is to examine if the use of reflexology can alleviate chronic constipation. The trial will last 26 week per patient, 2 week of screening period, 12 weeks of treatment and 12 weeks of follow up. Included in the study will be 40 men and women, 18 years of age or older, which are able to comply with the study guidelines; Fewer than three spontaneous bowel movement per week; and one or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months: (1) straining, lumpy or (2) hard stools, and (3) a sensation of incomplete evacuation. Exclusion criteria are: Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials; Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period; Rome III criteria for the irritable bowel syndrome; History of pelvic-floor dysfunction; Neurological pathologies; Psychiatric conditions; Chronic use of medication with a gastro intestinal-activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reflexology | Experimental | Procedure: Reflexologyreflexology treatment, x2-3/week for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18-55 years
- Fewer than three SBMs per week (occurring without the use of a laxative, enema, or suppository within the preceding 24 hours)
- One or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months:(1)straining, lumpy or (2) hard stools, and (3)a sensation of incomplete evacuation Six or fewer SBMs/week and fewer than three complete CSBMs/week during the 14-day baseline period.
- Ability to comply with the study guidelines
Key exclusion criteria (7 listed)
- Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials.
- Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period.
- Rome III criteria for the irritable bowel syndrome.
- History of pelvic-floor dysfunction.
- Neurological pathologies
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 |
|---|---|---|
| ReflexologyReflexology is a therapy whereby diagnosis and treatment are done on the patient's feet. According to reflexology, our feet are a micro-cosmos of our bodies and contain all the body's systems and internal organs. The treatment is palpation and massage of specific reflex points that respond to the body organs. This massage or palpitation of reflex points improves the physical function of the corresponding organ or system | Procedure or surgery | Reflexology |
Primary outcome
Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks
Time frame: 24 weeks
Will be assessed daily during the 24 weeks of the study
Increase of at least one CSBM per week from baseline for 9 or more weeks during the 24-week treatment period
Time frame: 24 weeks
Will be assessed weekly during the 24 weeks of the study
10 secondary outcomes
Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs)
Time frame: 24 weeks
Stool consistency/week using the 7- point Bristol Stool Form Scale, during the 24 weeks of the study period
Time frame: 24 weeks
Severity of straining using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount).
Time frame: 24 weeks
Abdominal discomfort, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)
Time frame: 24 weeks
Severity of bloating, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)
Time frame: 24 weeks
Constipation severity (using a 5-point ordinal scale, with higher scores indicating greater severity)
Time frame: 24 weeks
Constipation relief (based on a 7-point balanced scale, with 1 indicating complete relief, 4 indicating no change, and 7 indicating very severe constipation)
Time frame: 24 weeks
Satisfaction with the trial results, using a 5-point ordinal scale
Time frame: 24 weeks
Health related quality of life (using the validated Patient Assessment of Constipation Quality of Life instrument (PAC-QOL)
Time frame: 24 weeks
Treatment side effects
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
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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.
Menachem Oberbaum, MD principal investigator
Menachem Oberbaum, MD, Phone:+972-2-6666395, Email: oberbaum@szmc.org.il
Joseph Lysy principal investigator
Joseph Lysy,Phone: +972-2-6666116 Email: lysyj@szmc.org.il
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reflexology in people with Chronic Constipation, run by Shaare Zedek Medical Center at 1 site in Israel.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Jan 2013. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Menachem Oberbaum, MD (+972-2-6666395, oberbaum@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2013.