Ultrasound Assessment of Steroid Joint Injections in Juvenile Idiopathic Arthritis

NCT01114243 | Withdrawn

• 2 other identifiers: SU-03112010-5202IRB Protocol 17660
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (2)

• Steroid within the joint vs out of the joint

  Within 15 minutes of joint injection

• 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.

  6 months to 1 year

Secondary Outcomes (1)

• 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.

  6 mo

Interventions

Ultrasound imaging DEVICE

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Arthritis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Christy I. Sandborg

  Stanford University

  PRINCIPAL INVESTIGATOR

• Johanna Chi Chang

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: May 3, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 11, 2011

Record last verified: 2011-11

Locations

US (1)