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Reflexology for Chronic Constipation

Primary Purpose

Chronic Constipation

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Reflexology
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Chronic constipation, Reflexology, Complementary medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • The Center for Integrative Complementary Medicine, Shaare Zedek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reflexology

Arm Description

reflexology treatment, x2-3/week for 12 weeks

Outcomes

Primary Outcome Measures

Change in complete spontaneous bowel movements (CSBM)/week from baseline to 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
Will be assessed weekly during the 24 weeks of the study

Secondary Outcome Measures

Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs)
Will be assessed weekly during the 24 weeks of the study
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
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
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
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
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
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
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)
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)
Treatment side effects
Will be assessed at baseline, week 12 and week 24 (trial end)

Full Information

First Posted
May 6, 2012
Last Updated
January 14, 2013
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01599156
Brief Title
Reflexology for Chronic Constipation
Official Title
Reflexology for Patients Suffering From Chronic Constipation- a Phase II B, Single Armed, Open Label Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
Chronic constipation, Reflexology, Complementary medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reflexology
Arm Type
Experimental
Arm Description
reflexology treatment, x2-3/week for 12 weeks
Intervention Type
Procedure
Intervention Name(s)
Reflexology
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks
Description
Will be assessed daily during the 24 weeks of the study
Time Frame
24 weeks
Title
Increase of at least one CSBM per week from baseline for 9 or more weeks during the 24-week treatment period
Description
Will be assessed weekly during the 24 weeks of the study
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs)
Description
Will be assessed weekly during the 24 weeks of the study
Time Frame
24 weeks
Title
Stool consistency/week using the 7- point Bristol Stool Form Scale, during the 24 weeks of the study period
Description
Will be assessed weekly during the 24 weeks of the study
Time Frame
24 weeks
Title
Severity of straining using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount).
Description
Will be assessed daily during the 24 weeks of the study
Time Frame
24 weeks
Title
Abdominal discomfort, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)
Description
Will be assessed daily during the 24 weeks of the study
Time Frame
24 weeks
Title
Severity of bloating, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)
Description
Will be assessed daily during the 24 weeks of the study
Time Frame
24 weeks
Title
Constipation severity (using a 5-point ordinal scale, with higher scores indicating greater severity)
Description
Will be assessed weekly during the 24 weeks of the study
Time Frame
24 weeks
Title
Constipation relief (based on a 7-point balanced scale, with 1 indicating complete relief, 4 indicating no change, and 7 indicating very severe constipation)
Description
Will be assessed weekly during the 24 weeks of the study
Time Frame
24 weeks
Title
Satisfaction with the trial results, using a 5-point ordinal scale
Description
will be assessed at the 12-week visit and at the 24-week visit (at the study end)
Time Frame
24 weeks
Title
Health related quality of life (using the validated Patient Assessment of Constipation Quality of Life instrument (PAC-QOL)
Description
will be assessed at baseline; at the 12-week visit and at the 24-week visit (at the study end)
Time Frame
24 weeks
Title
Treatment side effects
Description
Will be assessed at baseline, week 12 and week 24 (trial end)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Menachem Oberbaum, MD
Phone
+972-2-6666395
Email
oberbaum@szmc.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Lysy, MD
Phone
+972-2-6666116
Email
lysyj@szmc.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menachem Oberbaum, MD
Organizational Affiliation
Menachem Oberbaum, MD, Phone:+972-2-6666395, Email: oberbaum@szmc.org.il
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Lysy
Organizational Affiliation
Joseph Lysy,Phone: +972-2-6666116 Email: lysyj@szmc.org.il
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Menachem Oberbaum, MD
Phone
+972-2-6666395
Email
oberbaum@szmc.org.il
First Name & Middle Initial & Last Name & Degree
Menachem Oberbaum, MD

12. IPD Sharing Statement

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Reflexology for Chronic Constipation

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