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NCT00471796 Clinical Trial

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)

Chest Pain Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00471796
Other study ID # NCCP-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 9, 2007
Last updated May 9, 2007

Study information
Verified date April 2007
Source Assaf-Harofeh Medical Center
Contact Michael Shapiro, MD
Phone +972-8-9779720
Email shapirom1@yahoo.com
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Biofeedback

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center
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