Ultrasound Assessment of Steroid Joint Injections in Juvenile Idiopathic Arthritis

This study has been withdrawn prior to enrollment.
(The PI has left Stanford University.)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01114243
First received: March 30, 2010
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

Juvenile idiopathic arthritis (JIA) is a serious autoimmune childhood disease that encompasses several types of chronic arthritis. It is the most common rheumatic disease in children and can cause significant short-term and long-term disability, including permanent joint damage. Management of JIA is based on a combination of pharmacologic interventions, physical and occupational therapy, and psychosocial support. Intra-articular steroid (IAS) injection, or injection of steroid medication into an arthritic joint, is a routine therapeutic procedure in clinical rheumatology. Most pediatric rheumatologists currently perform injections based on knowledge of anatomy and by feeling for anatomical landmarks, but results from adult studies on ultrasound (US)-guided technique have suggested a role for using US in treating and managing JIA. The overall goal of this project is to determine the feasibility of a multicenter study comparing US-guided IAS injection with the usual technique of using external anatomic features to improve arthritis symptoms in JIA. The key issues that this pilot project will determine will be: 1) the ability to use US to successfully image and detect abnormalities in the joints in children with JIA 2) image the injected medication in the joint space or its surroundings immediately after the injection 3) determine methods to measure the clinical response to injection 4) evaluate the feasibility of using saved US scans to localize injected medication in or around the joints and to determine abnormalities concerning for arthritis. These results will be used to establish the protocols necessary to design a multicenter study to determine the effect of US-guided IAS injection in the treatment of juvenile arthritis. Studies regarding the applicability and feasibility of musculoskeletal US in an outpatient pediatric rheumatology setting are important in order to establish the utility of this new technology in guiding diagnosis and therapy in JIA. Results from this study may have a significant impact on pediatric rheumatology and the way by which pediatric rheumatologists currently assess signs of arthritis and perform routine therapeutic procedures.


Condition Intervention
Arthritis
Device: Ultrasound imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study: Ultrasound Assessment of Steroid Joint Injections in Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Steroid within the joint vs out of the joint [ Time Frame: Within 15 minutes of joint injection ] [ Designated as safety issue: No ]
  • Each joint will receive a Clinical Score assessing swelling and limitation of motion with warmth or pain on motion on a scale of 0-3. Each joint will also receive an US Score which will assess effusion and/or synovitis on a scale of 0-3. [ Time Frame: 6 months to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in arthritis after steroid injection as defined by changes in clinical scoring and ultrasound scoring using Clinical Severity Score and Ultrasound Severity Score as defined above. [ Time Frame: 6 mo ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

We will enroll any gender and/or ethnic background child or young adult meeting the inclusion/exclusion criteria as detailed above.

Criteria

Inclusion Criteria:The first aim will be a two-part cross-sectional study comparing US imaging of active joints in 55 subjects with JIA to standardized clinical and functional measures, assuming that each subject will have at least 1 active joint. All subjects must meet the following criteria

  • Less than 21 years old
  • Have a diagnosis of JIA per ILAR classification
  • Have large and/ or medium joint synovitis

The second aim will study the use of US in imaging the placement of IAS and response to this therapy in 20 subjects receiving IAS for treatment of active arthritis in large and medium joints. Subjects must meet the following criteria:

  • Less than 21 years old
  • Have a diagnosis of JIA per ILAR classification
  • Will be receiving IAS injections of the knee, wrist, elbow, and/or ankle as part of their standard medical care

Exclusion Criteria:- Subjects with a non-inflammatory diagnosis, such as mechanical joint disease

  • Subjects with a large joint effusion requiring additional therapeutic procedures, such as arthrocentesis
  • Subjects 21 years old or older
  • Subjects without a diagnosis of JIA per ILAR classification
  • Subjects without large and/or medium joint synovitis
  • Subjects who do not require IAS injections of the knee, wrist, elbow, and/or ankle as part of standard medical care (for Aim 2 subjects)
  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: NCT01114243

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Christy I. Sandborg Stanford University
Principal Investigator: Johanna Chi Chang Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01114243     History of Changes
Other Study ID Numbers: SU-03112010-5202, IRB Protocol 17660
Study First Received: March 30, 2010
Last Updated: November 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014