Reflexology for Chronic Constipation

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

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.

Condition or disease	Intervention/treatment	Phase
Chronic Constipation	Procedure: Reflexology	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reflexology for Patients Suffering From Chronic Constipation- a Phase II B, Single Armed, Open Label Study.
• Study Start Date: July 2012
• Estimated Primary Completion Date: April 2013
• Estimated Study Completion Date: April 2013

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs) [ Time Frame: 24 weeks ]
   Will be assessed weekly during the 24 weeks of the study
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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)
9. 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)
10. Treatment side effects [ Time Frame: 24 weeks ]
    Will be assessed at baseline, week 12 and week 24 (trial end)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Shaare Zedek Medical Center
• ClinicalTrials.gov Identifier: NCT01599156
• Other Study ID Numbers: REF11
• First Posted: May 15, 2012
• Last Update Posted: January 15, 2013
• Last Verified: July 2012

Keywords provided by Shaare Zedek Medical Center:

Chronic constipation; Reflexology; Complementary medicine

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive