Reflexology for Chronic Constipation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01599156
First received: May 6, 2012
Last updated: January 14, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Chronic Constipation
Procedure: Reflexology
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reflexology for Patients Suffering From Chronic Constipation- a Phase II B, Single Armed, Open Label Study.

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Will be assessed weekly during the 24 weeks of the study


Secondary Outcome Measures:
  • Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Will be assessed at baseline, week 12 and week 24 (trial end)


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reflexology
reflexology treatment, x2-3/week for 12 weeks
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599156

Contacts
Contact: Menachem Oberbaum, MD +972-2-6666395 oberbaum@szmc.org.il
Contact: Joseph Lysy, MD +972-2-6666116 lysyj@szmc.org.il

Locations
Israel
The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: Menachem Oberbaum, MD    +972-2-6666395    oberbaum@szmc.org.il   
Principal Investigator: Menachem Oberbaum, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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
  More Information

No publications provided

Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01599156     History of Changes
Other Study ID Numbers: REF11
Study First Received: May 6, 2012
Last Updated: January 14, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
Chronic constipation
Reflexology
Complementary medicine

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014