Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia

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.

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 Overview

• Status: Unknown
• Conditions: Fibromyalgia; Ankylosing Spondylitis
• Intervention / Treatment: Device: Evaluation by manual Dolorimeter; Other: SIJ imaging

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jacob N Ablin, MD; Phone Number: 972-3-6973668; Email: ajacob@post.tau.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of Ankylosing Spondylitis as diagnosed according to ASAS criteria	1 month

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Jacob N Ablin, MD, Tel-Aviv Sourasky Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: January 24, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Estimate): August 6, 2010
• Last Update Submitted That Met QC Criteria: August 5, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Muscular Diseases; Neuromuscular Diseases; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Ankylosis; Fibromyalgia; Myofascial Pain Syndromes; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Spondylarthropathies
• Other Study ID Numbers: TASMC-10-JA-0423-CTIL