Reflexology for Chronic Constipation

Shaare Zedek Medical Center

Status and phase

Unknown

Phase 2

Conditions

Chronic Constipation

Treatments

Procedure: Reflexology

Study type

Interventional

Funder types

Other

Identifiers

NCT01599156

REF11

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.