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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)

NCT ID: NCT00471796

Last Updated: 2007-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Chest Pain Heartburn

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Biofeedback

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Michael Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Central Contacts

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Michael Shapiro, MD

Role: CONTACT

[email protected]
+972-8-9779720

Other Identifiers

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NCCP-2

Identifier Type: -

Identifier Source: org_study_id