Chronic Constipation | Reflexology for Chronic Constipation
Chronic Constipation research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:ReflexologyReflexology 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Reflexologyreflexology treatment, x2-3/week for 12 weeks
Start Date: July 2012
Completed Date: April 2013
Phase: Phase 2
Primary Outcome: Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks
Secondary Outcome: Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs)
Study sponsors, principal investigator, and references
Principal Investigator: Menachem Oberbaum, MD
Lead Sponsor: Shaare Zedek Medical Center