A Comparison of Factors of Symptoms Generation and Evaluation of Role of Biofeedback in Patients With Different Types of Functional Esophageal Disorders (Functional Heartburn and Functional Chest Pain)

This study is not yet open for participant recruitment.

Verified by Assaf-Harofeh Medical Center, April 2007

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00471796

Purpose

There is supposed that patients with functional esophageal disorders such as functional heartburns and functional chest pain have common underlying mechanisms of symptom generation. These include esophageal dysmotility, non-acidic gastro-esophageal reflux, duodeno-gastro-esophageal reflux, esophageal hypersensitivity, and psychological comorbidity.

The treatment of these patients is the growing challenge in the primary care medicine and in the gastroenterological practice. It was postulated that functional disorders of the esophagus are the main reason for PPI failure in patients with heartburn.

The aim of the study is to evaluate the role of biofeedback in the treatment of patients with functional chest pain and functional heartburns.

Condition	Intervention
Chest Pain Heartburn	Behavioral: Biofeedback

MedlinePlus related topics: Chest Pain Esophagus Disorders Heartburn

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Men and women ages 18-75.
Willing to participate and sign an inform consent.
Having heartburns, acid regurgitations and/or chest pain at least twice a week for at least 3 months.
Ability to stop anti-acid and anti-pain medications for at least two weeks.

Exclusion Criteria:

History of upper gastrointestinal surgery.
Concomitant diseases that may affect esophageal perception (diabetes mellitus, neuropathy).
Concomitant medications that may affect esophageal perception (anti-inflammatory, anti-depressants drugs).
Pregnancy.
Severe conditions such as cardiac failure, renal failure and other that may be contraindication for upper endoscopy.
Erosive esophagitis on upper endoscopy or pathological result of ambulatory 24-hour pH monitoring.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471796

Contacts

Contact: Michael Shapiro, MD

+972-8-9779720

shapirom1@yahoo.com

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

Principal Investigator:

Michael Shapiro, MD

Assaf-Harofeh Medical Center

More Information

Study ID Numbers:	NCCP-2
Study First Received:	May 9, 2007
Last Updated:	May 9, 2007
ClinicalTrials.gov Identifier:	NCT00471796
Health Authority:	Israel: Ethics Commission

Keywords provided by Assaf-Harofeh Medical Center:

Patients with functional chest pain and functional heartburns

Study placed in the following topic categories:

Signs and Symptoms
Pyrosis
Esophageal disorder
Signs and Symptoms, Digestive

Heartburn
Pain
Esophageal Diseases
Chest Pain

ClinicalTrials.gov processed this record on January 14, 2009