Intra-articular Glucocorticoid Treatment of the Elbow

This study has been completed.
Sponsor:
Collaborator:
Meda AB
Information provided by:
Department of Research and Development, County Council of Gavleborg and Uppsala University
ClinicalTrials.gov Identifier:
NCT00972530
First received: September 3, 2009
Last updated: October 9, 2009
Last verified: October 2009
  Purpose

BACKGROUND: Intra-articular glucocorticoid injections are frequently used to relieve symptoms of arthritis. Postinjection rest has been shown to improve the outcome of knee joint injections, but not for wrist injections. Consequently, different joints respond differently on postinjection regimens.

OBJECTIVES: To investigate whether better treatment results might be achieved of post-injection rest following intra-articular glucocorticoid treatment for elbow synovitis.

METHODS: 90 patients with rheumatoid arthritis (RA) and elbow synovitis were treated with 20 mg intra-articular triamcinolone hexacetonide and randomised to either a 48 hour immobilisation in a triangular sling (n=46) or normal activity without restrictions (n=44). Primary endpoint was relapse of synovitis. In addition, pain, function according to a self assessment questionnaire (PREE) and range of movement were followed for six months.


Condition Intervention
Rheumatoid Arthritis
Behavioral: immobilisation in a triangular sling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Importance of Immobilisation After Intra-articular Glucocorticoid Treatment for Elbow Synovitis - a Randomised and Controlled Study

Resource links provided by NLM:


Further study details as provided by Department of Research and Development, County Council of Gavleborg and Uppsala University:

Primary Outcome Measures:
  • Relapse of Arthritis [ Time Frame: Regular visits at one week, 3 months and 6 months. ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Activity
Normal activity without restrictions
Active Comparator: immobilisation
48 hours postinjection rest
Behavioral: immobilisation in a triangular sling

Intervention group: Immobilisation 48 hours in a triangular sling (mitella)

Control group: normal activity without restrictions

Other Names:
  • Postinjection rest
  • normal joint usage

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis, and
  • Clinical signs of elbow synovitis

Exclusion Criteria:

  • Patients in function class 4 according to Steinbrocker as well as patients with oral glucocorticoid treatment corresponding to more than 7.5 mg prednisolone or intra-articular treatment in the joint the past three months
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00972530

Sponsors and Collaborators
Department of Research and Development, County Council of Gavleborg and Uppsala University
Meda AB
Investigators
Principal Investigator: Tomas Weitoft, MD PhD Department of Research and Development County Council of Gävleborg/Uppsala University
  More Information

No publications provided by Department of Research and Development, County Council of Gavleborg and Uppsala University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MD PhD Tomas Weitoft, Department of Research and Development, County Council of Gavleborg and Uppsala University
ClinicalTrials.gov Identifier: NCT00972530     History of Changes
Other Study ID Numbers: Dnr 2005:362
Study First Received: September 3, 2009
Results First Received: September 10, 2009
Last Updated: October 9, 2009
Health Authority: Sweden: National Board of Health and Welfare

Keywords provided by Department of Research and Development, County Council of Gavleborg and Uppsala University:
rheumatoid arthritis
treatment

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014