Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fibromyalgia Ankylosing Spondylitis |
Device: Evaluation by manual Dolorimeter Other: SIJ imaging |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia - Application of the ASAS Classification Criteria |
- Prevalence of Ankylosing Spondylitis as diagnosed according to ASAS criteria [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
FIbromyalgia Patients
Patients diagnosed as suffering from Fibromyalgia according to the ACR criteria
|
Device: Evaluation by manual Dolorimeter
Patients will be examined by a manual Dolorimeter
Other: SIJ imaging
Patients will undergo imaging of the Sacroiliac joint by plain x-ray or MRI and sacroileitis will be documented
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients will be recruited consecutively from the Fibromyalgia clinic as well as the general rheumatological clinic of the Tel Aviv Sourasky medical center.
Inclusion Criteria:
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
Exclusion Criteria:
- Patients with known inflammatory joint disease prior to the study
- Patient not able to give informed consent
- Pregnant women
Contacts and Locations| Contact: Jacob N Ablin, MD | 972-3-6973668 | ajacob@post.tau.ac.il |
| Principal Investigator: | Jacob N Ablin, MD | Tel-Aviv Sourasky Medical Center |
More Information
Publications:
| Responsible Party: | Jacob Ablin, MD, Director, Fibromyalgia Clinic, Institute of Rheumatology, Tel Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT01167413 History of Changes |
| Other Study ID Numbers: | TASMC-10-JA-0423-CTIL |
| Study First Received: | January 24, 2010 |
| Last Updated: | August 5, 2010 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Spondylitis Spondylitis, Ankylosing Stress, Psychological Spondylarthropathies Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases |
Nervous System Diseases Bone Diseases, Infectious Infection Bone Diseases Spinal Diseases Spondylarthritis Ankylosis Joint Diseases Arthritis Behavioral Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013