Reflexology for Chronic Constipation

NCT ID: NCT01599156

Last Updated: 2013-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-04-30

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.

Conditions

Chronic Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reflexology

reflexology treatment, x2-3/week for 12 weeks

Group Type: EXPERIMENTAL

Reflexology

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Menachem Oberbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Menachem Oberbaum, MD, Phone:+972-2-6666395, Email: oberbaum@szmc.org.il

Joseph Lysy

Role: PRINCIPAL_INVESTIGATOR

Joseph Lysy,Phone: +972-2-6666116 Email: lysyj@szmc.org.il

Locations

The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Menachem Oberbaum, MD

Role: CONTACT

oberbaum@szmc.org.il

+972-2-6666395

Joseph Lysy, MD

Role: CONTACT

lysyj@szmc.org.il

+972-2-6666116

Facility Contacts

Menachem Oberbaum, MD

Role: primary

oberbaum@szmc.org.il

+972-2-6666395

Other Identifiers

REF11

Identifier Type: -

Identifier Source: org_study_id