Frequency of Axial Spondyloarthropathy Among Patients Suffering From Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01167413
First received: January 24, 2010
Last updated: August 5, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167413

Contacts
Contact: Jacob N Ablin, MD 972-3-6973668 ajacob@post.tau.ac.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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:
Bone Diseases, Infectious
Fibromyalgia
Myofascial Pain Syndromes
Spondylitis
Spondylitis, Ankylosing
Stress, Psychological
Spondylarthropathies
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Infection
Bone Diseases
Spinal Diseases
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 01, 2014