Back to resultsA 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)
Primary Purpose
Chest Pain, Heartburn
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Chest Pain focused on measuring Patients with functional chest pain and functional heartburns
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00471796
Brief Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Heartburn
Keywords
Patients with functional chest pain and functional heartburns
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Shapiro, MD
Phone
+972-8-9779720
Email
shapirom1@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Shapiro, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this 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)
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