Reflexology for Chronic Constipation

Chronic Constipation Clinical Trial

Official title: Reflexology for Patients Suffering From Chronic Constipation- a Phase II B, Single Armed, Open Label Study.

Status Recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

• NCT number: NCT01599156
• Study type: Interventional
• Source: Shaare Zedek Medical Center
• Contact: Menachem Oberbaum, MD
• Phone: +972-2-6666395
• Email: oberbaum@szmc.org.il
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2012
• Completion date: April 2013