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)

NCT00471796 | Unknown

• 1 other identifier: NCCP-2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chest Pain; Heartburn

Keywords

Patients with functional chest pain and functional heartburns

Interventions

Biofeedback BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

MeSH Terms

Conditions

Chest Pain; Heartburn

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Michael Shapiro, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Shapiro, MD

CONTACT

+972-8-9779720; shapirom1@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 9, 2007
• First Posted: May 10, 2007
• Last Updated: May 10, 2007

Record last verified: 2007-04