Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia

NCT ID: NCT01167413

Last Updated: 2010-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FIbromyalgia Patients

Patients diagnosed as suffering from Fibromyalgia according to the ACR criteria

Evaluation by manual Dolorimeter

Intervention Type DEVICE

Patients will be examined by a manual Dolorimeter

SIJ imaging

Intervention Type OTHER

Patients will undergo imaging of the Sacroiliac joint by plain x-ray or MRI and sacroileitis will be documented

Interventions

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Evaluation by manual Dolorimeter

Patients will be examined by a manual Dolorimeter

Intervention Type DEVICE

SIJ imaging

Patients will undergo imaging of the Sacroiliac joint by plain x-ray or MRI and sacroileitis will be documented

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel Aviv Sourasky Medical Center

Principal Investigators

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Jacob N Ablin, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Central Contacts

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Jacob N Ablin, MD

Role: CONTACT

972-3-6973668

References

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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.

Reference Type BACKGROUND
PMID: 17476510 (View on PubMed)

Sieper 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.

Reference Type BACKGROUND
PMID: 19433414 (View on PubMed)

Wolfe 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.

Reference Type BACKGROUND
PMID: 2306288 (View on PubMed)

Other Identifiers

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TASMC-10-JA-0423-CTIL

Identifier Type: -

Identifier Source: org_study_id

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