Chronic Widespread PainNCT00721318
A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population in Tallinn and Harjumaa County
An observational study of Chronic Widespread Pain, run by Estonian Society for Rheumatology at 1 site in Estonia.
Trial summary
The chronic widespread pain (CWP) and fibromyalgia (FM) cause serious discomfort, but at the same time they are not life threatening and they cannot be detected by any laboratory tests. The problems connected with these conditions have gained little attention in Estonia so far. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Widespread Pain
- How many people
- 6,000 participants
- Where
- 1 siteEstonia
- Study dates
- May 2008to May 2010
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population: Tallinn and Harju County (Estonia), population 552,000. The residents of both Tallinn and Harju County receive national health care services.
2000 RA patients from the East Tallinn Central Hospital's and the North Estonian Regional Hospital's in- and outpatients who live in Tallinn or Harju County
The control sample will be found from the Population Register through matching by gender, age (the same year) and place of residence (living in the city or in the countryside) with the subjects from RA sample according to the official procedure. If required, the research subjects from the control sample will be contacted by a rheumatologist participating in the study.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population Matched by Gender, Age and Place of Residence in Tallinn and Harjumaa County
The chronic widespread pain (CWP) and fibromyalgia (FM) cause serious discomfort, but at the same time they are not life threatening and they cannot be detected by any laboratory tests. The problems connected with these conditions have gained little attention in Estonia so far. It can be assumed that the CWP and FM often remain undetected and the sufferers live without treatment they need.
So far, there are no data on the prevalence of the CWP and FM in Estonia available.
Read more
The goal of the current research is to assess the prevalence of the CWP and local pain syndromes among Estonia's RA patients and among the control population in Tallinn and Harju County; also the factors connected with the presence of the pain and the pain treatment in use.
At the same time there will be a similarly designed research conducted in Jyväskylä Central Hospital, which provides the opportunity to compare results in Estonia's and Finland's research groups. The study on the distribution of the chronic pain among RA patients and control population will allow to assess the magnitude of the problem in Estonia and to raise the awareness of physicians about CWP and significance of its treatment.
Performing the study will provide an experience which forms the base for further epidemiological and clinical research on CWP and FM
- Conditions
- Chronic Widespread Pain
- Keywords
- chronic widespread pain, fibromyalgia, rheumatoid arthritis, Estonia
- Medical subject headings
- Chronic Pain, Fibromyalgia, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients diagnosed with rheumatoid arthritis | |
| 2 | Population controls to the subjects of group 1 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Widespread 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Estonian Society for Rheumatology
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721318
- Sponsor's protocol ID
- Merck35016
- Other IDs
- 35016
- Status last verified
- Jul 2008
- First submitted
- 22 Jul 2008
- Last updated
- 24 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population Matched by Gender, Age and Place of Residence in Tallinn and Harjumaa County
- ClinicalTrials.gov ID
- NCT00721318
- Acronym / sponsor ID
- Merck35016
- Conditions
- Chronic Widespread Pain
- Keywords
- chronic widespread pain, fibromyalgia, rheumatoid arthritis, Estonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Estonian Society for RheumatologyUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 24 Jul 2008 (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 chronic widespread pain (CWP) and fibromyalgia (FM) cause serious discomfort, but at the same time they are not life threatening and they cannot be detected by any laboratory tests. The problems connected with these conditions have gained little attention in Estonia so far. It can be assumed that the CWP and FM often remain undetected and the sufferers live without treatment they need.
So far, there are no data on the prevalence of the CWP and FM in Estonia available.
The goal of the current research is to assess the prevalence of the CWP and local pain syndromes among Estonia's RA patients and among the control population in Tallinn and Harju County; also the factors connected with the presence of the pain and the pain treatment in use.
At the same time there will be a similarly designed research conducted in Jyväskylä Central Hospital, which provides the opportunity to compare results in Estonia's and Finland's research groups. The study on the distribution of the chronic pain among RA patients and control population will allow to assess the magnitude of the problem in Estonia and to raise the awareness of physicians about CWP and significance of its treatment.
Performing the study will provide an experience which forms the base for further epidemiological and clinical research on CWP and FM
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients diagnosed with rheumatoid arthritis |
| 2 | – | –Population controls to the subjects of group 1 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population: Tallinn and Harju County (Estonia), population 552,000. The residents of both Tallinn and Harju County receive national health care services.
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
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 24 Jul 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Widespread Pain, run by Estonian Society for Rheumatology at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jul 2008. 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 Estonia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 24 Jul 2008.