FibromyalgiaNCT01203865
Prevalence of Fibromyalgia in Israel
An observational study of Fibromyalgia, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The prevalence of fibromyalgia syndrome in the Israeli population is of importance fro planning resource allocation of medical expenditure as well as for identifying demographic and ethnic differences of this unique population compared with other western samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- How many people
- 1,200 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Mar 2012
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Telephone survey - general population over age 18 Rheumatology patients - patients attending the rheumatology clinic for any reason
Who may be able to join
- Individuals over 18 who consent to answer the survey questions
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv SOurasky Medical center
Tel Aviv
Jacob N Ablin, MD, 972-3-6973668, jacobab@tasmc.health.gov.il
Jacob N Ablin, MD
About this study
The prevalence of fibromyalgia syndrome in the Israeli population is of importance fro planning resource allocation of medical expenditure as well as for identifying demographic and ethnic differences of this unique population compared with other western samples. In the current study the investigators aim at estimating the prevalence of fibromyalgia in this population. For this purpose a two - stage process will be used. First, a population survey will be conducted by telephone, screening for widespread pain and fatigue in the general population. This survey will use the London Fibromyalgia Epidemiology Study Screening Questionnaire. Second, a sample of patients attending the rheumatology clinic will be surveyed with this tool and will be examined in order to determine the actual proportion of patients fulfilling ACR criteria for fibromyalgia. This will enable us to calculate the positive predictive value of the London Fibromyalgia Epidemiology Study Screening Questionnaire in our population and hence to calculate the prevalence of fibromyalgia in the population.
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Fatigue
- Medical subject headings
- Fibromyalgia, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of fibromyalgia in the Israeli population
Measured: 9 months
Secondary outcomes (1)
Demographic data on fibromyalgia patients
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Jacob N Ablin, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203865
- Sponsor's protocol ID
- 0303-10-TLV
- Other IDs
- WS573984
- Status last verified
- Oct 2011
- First submitted
- 15 Sep 2010
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubere JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010 Jun;39(6):448-53. doi: 10.1016/j.semarthrit.2008.12.003. Epub 2009 Feb 27.
PubMed 19250656
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Fibromyalgia in Israel
- ClinicalTrials.gov ID
- NCT01203865
- Acronym / sponsor ID
- 0303-10-TLV
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Fatigue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Pfizer
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 16 Sep 2010 (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.
The prevalence of fibromyalgia syndrome in the Israeli population is of importance fro planning resource allocation of medical expenditure as well as for identifying demographic and ethnic differences of this unique population compared with other western samples. In the current study the investigators aim at estimating the prevalence of fibromyalgia in this population. For this purpose a two - stage process will be used. First, a population survey will be conducted by telephone, screening for widespread pain and fatigue in the general population. This survey will use the London Fibromyalgia Epidemiology Study Screening Questionnaire. Second, a sample of patients attending the rheumatology clinic will be surveyed with this tool and will be examined in order to determine the actual proportion of patients fulfilling ACR criteria for fibromyalgia. This will enable us to calculate the positive predictive value of the London Fibromyalgia Epidemiology Study Screening Questionnaire in our population and hence to calculate the prevalence of fibromyalgia in the population.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Telephone survey - general population over age 18 Rheumatology patients - patients attending the rheumatology clinic for any reason
Key inclusion criteria (1 listed)
- Individuals over 18 who consent to answer the survey questions
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of fibromyalgia in the Israeli population
Time frame: 9 months
1 secondary outcome
Demographic data on fibromyalgia patients
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
- Background: PubMed 19250656Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubere JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010 Jun;39(6):448-53. doi: 10.1016/j.semarthrit.2008.12.003. Epub 2009 Feb 27.
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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.
Jacob N Ablin, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 0 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 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jacob N Ablin, MD (972-3-6973668, jacobab@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of fibromyalgia in the Israeli population (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01203865, which also lists 1 linked publication.
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 12 Oct 2011.