FibromyalgiaNCT01167413
Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia
An observational study of Fibromyalgia and Ankylosing Spondylitis, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Fibromyalgia Syndrome (FMS) is a non - inflammatory condition characterized by the presence of chronic, widespread musculoskeletal pain and tenderness; FMS is considered to be the result of increased processing of pain by the central nervous system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Ankylosing Spondylitis
- What is being tested?
- Evaluation by manual Dolorimeter and SIJ imaging
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jan 2011
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited consecutively from the Fibromyalgia clinic as well as the general rheumatological clinic of the Tel Aviv Sourasky medical center.
Who may be able to join
- Patients fulfilling American College of Rheumatology criteria for classification of Fibromyalgia:
- Widespread pain lasting over three months
- Tenderness in at least 11 of 18 points
Who cannot join
- Patients with known inflammatory joint disease prior to the study
- Patient not able to give informed consent
- Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia - Application of the ASAS Classification Criteria
Fibromyalgia Syndrome (FMS) is a non - inflammatory condition characterized by the presence of chronic, widespread musculoskeletal pain and tenderness; FMS is considered to be the result of increased processing of pain by the central nervous system.
Axial spondyloarthropathy is the hallmark of Ankylosing Spondylitis (AS), an inflammatory joint disease involving the axial spine, the sacroiliac joints as well as peripheral joints.
Read more
Although FMS and AS differ vastly in their pathogenesis, a considerable clinical overlap may exist between these conditions. Both disorders typically cause chronic nocturnal back pain and disturbed sleep may accompany either condition. In addition,the investigators have previously described an increased prevalence of (secondary) FMS among female AS patients.
This overlap may have important clinical implications since the presence of comorbid FMS may lead to increased severity results on commonly used instruments in the evaluation of disease activity in AS, such as the BASDAI and BASFI .
Recently, the Assessment of Spondyloarthritis international Society (ASAS) has published updated classification criteria for axial spondyloarthropathy. These criteria, which are summarized in table 1, are based on the evaluation of patients suffering from chronic back pain with an age of onset of less than 45.
Objective:
The objective of the current study is to evaluate the prevalence of axial spondyloarthropathies among FMS patients, utilizing the new ASAS criteria.
- Conditions
- Fibromyalgia, Ankylosing Spondylitis
- Being tested
- Evaluation by manual Dolorimeter, SIJ imaging
- Medical subject headings
- Fibromyalgia, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation by manual DolorimeterDevice
Patients will be examined by a manual Dolorimeter
SIJ imagingOther
Patients will undergo imaging of the Sacroiliac joint by plain x-ray or MRI and sacroileitis will be documented
| Study group | Role | What they receive |
|---|---|---|
| FIbromyalgia Patients | Patients diagnosed as suffering from Fibromyalgia according to the ACR criteria Receives: Device: Evaluation by manual Dolorimeter; Other: SIJ imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Ankylosing Spondylitis as diagnosed according to ASAS criteria
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Jacob N Ablin, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167413
- Sponsor's protocol ID
- TASMC-10-JA-0423-CTIL
- Status last verified
- Jan 2010
- First submitted
- 24 Jan 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Aloush V, Ablin JN, Reitblat T, Caspi D, Elkayam O. Fibromyalgia in women with ankylosing spondylitis. Rheumatol Int. 2007 Jul;27(9):865-8. doi: 10.1007/s00296-007-0344-3. Epub 2007 May 3.
PubMed 17476510Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, Dougados M, Hermann KG, Landewe R, Maksymowych W, van der Heijde D. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009 Jun;68 Suppl 2:ii1-44. doi: 10.1136/ard.2008.104018.
PubMed 19433414Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
PubMed 2306288
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia - Application of the ASAS Classification Criteria
- ClinicalTrials.gov ID
- NCT01167413
- Acronym / sponsor ID
- TASMC-10-JA-0423-CTIL
- Conditions
- Fibromyalgia, Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 22 Jul 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.
Fibromyalgia Syndrome (FMS) is a non - inflammatory condition characterized by the presence of chronic, widespread musculoskeletal pain and tenderness; FMS is considered to be the result of increased processing of pain by the central nervous system.
Axial spondyloarthropathy is the hallmark of Ankylosing Spondylitis (AS), an inflammatory joint disease involving the axial spine, the sacroiliac joints as well as peripheral joints.
Although FMS and AS differ vastly in their pathogenesis, a considerable clinical overlap may exist between these conditions. Both disorders typically cause chronic nocturnal back pain and disturbed sleep may accompany either condition. In addition,the investigators have previously described an increased prevalence of (secondary) FMS among female AS patients.
This overlap may have important clinical implications since the presence of comorbid FMS may lead to increased severity results on commonly used instruments in the evaluation of disease activity in AS, such as the BASDAI and BASFI .
Recently, the Assessment of Spondyloarthritis international Society (ASAS) has published updated classification criteria for axial spondyloarthropathy. These criteria, which are summarized in table 1, are based on the evaluation of patients suffering from chronic back pain with an age of onset of less than 45.
Objective:
The objective of the current study is to evaluate the prevalence of axial spondyloarthropathies among FMS patients, utilizing the new ASAS criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIbromyalgia Patients | – | Device: Evaluation by manual Dolorimeter, Other: SIJ imagingPatients diagnosed as suffering from Fibromyalgia according to the ACR criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited consecutively from the Fibromyalgia clinic as well as the general rheumatological clinic of the Tel Aviv Sourasky medical center.
Key inclusion criteria (3 listed)
- Patients fulfilling American College of Rheumatology criteria for classification of Fibromyalgia:
- Widespread pain lasting over three months
- Tenderness in at least 11 of 18 points
Key exclusion criteria (3 listed)
- Patients with known inflammatory joint disease prior to the study
- Patient not able to give informed consent
- Pregnant women
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 |
|---|---|---|
| Evaluation by manual DolorimeterPatients will be examined by a manual Dolorimeter | Device | FIbromyalgia Patients |
| SIJ imagingPatients will undergo imaging of the Sacroiliac joint by plain x-ray or MRI and sacroileitis will be documented | Other | FIbromyalgia Patients |
Primary outcome
Prevalence of Ankylosing Spondylitis as diagnosed according to ASAS criteria
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2010.
- Background: PubMed 17476510Aloush V, Ablin JN, Reitblat T, Caspi D, Elkayam O. Fibromyalgia in women with ankylosing spondylitis. Rheumatol Int. 2007 Jul;27(9):865-8. doi: 10.1007/s00296-007-0344-3. Epub 2007 May 3.
- Background: PubMed 19433414Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, Dougados M, Hermann KG, Landewe R, Maksymowych W, van der Heijde D. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009 Jun;68 Suppl 2:ii1-44. doi: 10.1136/ard.2008.104018.
- Background: PubMed 2306288Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Ankylosing Spondylitis, run by Tel-Aviv Sourasky 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 3 inclusion and 3 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 6 Aug 2010. 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 Jacob N Ablin, MD (972-3-6973668, ajacob@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Ankylosing Spondylitis as diagnosed according to ASAS criteria (time frame: 1 month). 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 NCT01167413, which also lists 3 linked publications.
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 6 Aug 2010.