Chest PainNCT00471796
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)
A study testing Biofeedback in people with Chest Pain and Heartburn, run by Assaf-Harofeh Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chest Pain, Heartburn
- What is being tested?
- Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Biofeedback
- Keywords
- Patients with functional chest pain and functional heartburns
- Medical subject headings
- Chest Pain, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Michael Shapiro, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471796
- Sponsor's protocol ID
- NCCP-2
- Status last verified
- Apr 2007
- First submitted
- 9 May 2007
- Last updated
- 10 May 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00471796
- Acronym / sponsor ID
- NCCP-2
- Conditions
- Chest Pain, Heartburn
- Keywords
- Patients with functional chest pain and functional heartburns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- First posted
- 10 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Shapiro, MD principal investigator
Assaf-Harofeh Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Chest Pain and Heartburn, run by Assaf-Harofeh Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Shapiro, MD (+972-8-9779720, shapirom1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2007.