Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia - Application of the ASAS Classification Criteria

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01167413
• Other study ID #: TASMC-10-JA-0423-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 24, 2010
• Last updated: August 5, 2010
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Jacob N Ablin, MD
• Phone: 972-3-6973668
• Email: ajacob[@]post.tau.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Fibromyalgia
• Myofascial Pain Syndromes
• Spondylarthropathies
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

References & Publications (3)

Aloush V, Ablin JN, Reitblat T, Caspi D, Elkayam O. Fibromyalgia in women with ankylosing spondylitis. Rheumatol Int. 2007 Jul;27(9):865-8. Epub 2007 May 3. — View Citation

Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, Dougados M, Hermann KG, Landewé 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Ankylosing Spondylitis as diagnosed according to ASAS criteria		1 month	No