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Reflexology for Chronic Constipation

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ClinicalTrials.gov Identifier: NCT01599156
Recruitment Status : Unknown
Verified July 2012 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : May 15, 2012
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE May 6, 2012
First Posted Date  ICMJE May 15, 2012
Last Update Posted Date January 15, 2013
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2012)
  • Three or more complete spontaneous bowel movements (CSBM)/week [ Time Frame: 24 weeks ]
    Will be assessed daily during the 12 weeks of the study and the 12 weeks of the follow up period.
  • Increase of at least one CSBM per week from baseline for 9 or more weeks during the 12-week treatment period [ Time Frame: 24 weeks ]
    Will be assessed daily during the 12 weeks of the study and the 12 weeks of the follow up period.
Change History Complete list of historical versions of study NCT01599156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
  • Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs) [ Time Frame: 24 weeks ]
    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 [ Time Frame: 24 weeks ]
    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). [ Time Frame: 24 weeks ]
    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) [ Time Frame: 24 weeks ]
    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) [ Time Frame: 24 weeks ]
    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) [ Time Frame: 24 weeks ]
    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) [ Time Frame: 24 weeks ]
    Will be assessed weekly during the 24 weeks of the study
  • Satisfaction with the trial results, using a 5-point ordinal scale [ Time Frame: 24 weeks ]
    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) [ Time Frame: 24 weeks ]
    will be assessed at baseline; at the 12-week visit and at the 24-week visit (at the study end)
  • Treatment side effects [ Time Frame: 24 weeks ]
    Will be assessed at baseline, week 12 and week 24 (trial end)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2012)
  • Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs) [ Time Frame: 24 weeks ]
    Will be assessed daily during the 12 weeks of the study and the 12 weeks of the follow up period.
  • Stool consistency/week using the 7- point Bristol Stool Form Scale, during the 12 weeks of the study and the 12 weeks of the follow up period [ Time Frame: 24 weeks ]
    Will be assessed daily during the 12 weeks of the study and the 12 weeks of the follow up period.
  • Severity of straining using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount). [ Time Frame: 24 weeks ]
    Will be assessed daily during the 12 weeks of the study and the 12 weeks of the follow up period.
  • Abdominal discomfort, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount) [ Time Frame: 24 weeks ]
    Will be assessed daily during the 12 weeks of the study and the 12 weeks of the follow up period.
  • Severity of bloating, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount) [ Time Frame: 24 weeks ]
    Will be assessed daily during the 12 weeks of the study and the 12 weeks of the follow up period.
  • Constipation severity (using a 5-point ordinal scale, with higher scores indicating greater severity) [ Time Frame: 24 weeks ]
    Will be assessed weekly
  • 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 ]
    Will be assessed weekly
  • Satisfaction with the trial results, using a 5-point ordinal scale [ Time Frame: 24 weeks ]
    will be assessed at all visits (weeks 12 and 24)
  • Health related quality of life (using the validated Patient Assessment of Constipation Quality of Life instrument (PAC-QOL) [ Time Frame: 24 weeks ]
    Will be assessed at baseline, week 12 and week 24 (trial end)
  • Treatment side effects [ Time Frame: 24 weeks ]
    Will be assessed at baseline, week 12 and week 24 (trial end)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reflexology for Chronic Constipation
Official Title  ICMJE Reflexology for Patients Suffering From Chronic Constipation- a Phase II B, Single Armed, Open Label Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Constipation
Intervention  ICMJE Procedure: Reflexology
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 Arms  ICMJE Experimental: Reflexology
reflexology treatment, x2-3/week for 12 weeks
Intervention: Procedure: Reflexology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 13, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2013
Estimated Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01599156
Other Study ID Numbers  ICMJE REF11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Menachem Oberbaum, MD Menachem Oberbaum, MD, Phone:+972-2-6666395, Email: oberbaum@szmc.org.il
Principal Investigator: Joseph Lysy Joseph Lysy,Phone: +972-2-6666116 Email: lysyj@szmc.org.il
PRS Account Shaare Zedek Medical Center
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP