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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00471796
Recruitment Status : Unknown
Verified April 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 10, 2007
Last Update Posted : May 10, 2007
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Chest Pain Heartburn Behavioral: Biofeedback Not Applicable

Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00471796

Contact: Michael Shapiro, MD +972-8-9779720

Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Michael Shapiro, MD Assaf-Harofeh Medical Center Identifier: NCT00471796     History of Changes
Other Study ID Numbers: NCCP-2
First Posted: May 10, 2007    Key Record Dates
Last Update Posted: May 10, 2007
Last Verified: April 2007

Keywords provided by Assaf-Harofeh Medical Center:
Patients with functional chest pain and functional heartburns

Additional relevant MeSH terms:
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive