Constipation | Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
Constipation research study
What is the primary objective of this study?
The purpose of this study is to evaluate the effects of Functional Magnetic stimulation (FMS) on gastrointestinal motility in patients suffering from chronic constipation due to non-neurological issues.
Who is eligible to participate?
Inclusion Criteria: - Age 18-80 - constipation defined by the Rome II criteria Exclusion Criteria: - Past history of abdominal surgery - past history of diabetes mellitus - past history of hypothyroidism - past history of inflammatory bowel disease - past history of significant psychiatric disturbances - past history of drug abuse - past history of cardiac pacemakers - past history of metal implants - patients who cannot travel to keep the follow up - patients who are prisoners - patients who are mentally handicapped - patients who are pregnant
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.
Device:Functional Magnetic Stimulation20 minute stimulation will be applied 5 days a week for 5 weeks
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.
TreatmentFMS will be administered for 5 weeks
ShamFMS at 5% intensity for 5 weeks
Start Date: December 2012
Completed Date: October 2015
Primary Outcome: Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol
Secondary Outcome: Effectiveness of FMS in reducing the colonic transit time in patients with non-neurological constipation after a 5 week conditioning period
Study sponsors, principal investigator, and references
Principal Investigator: Massarat Zutshi, MD
Lead Sponsor: The Cleveland Clinic