Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intra-articular Glucocorticoid Treatment of the Elbow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00972530
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : November 11, 2009
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Meda AB
Information provided by (Responsible Party):
Region Gävleborg

Brief Summary:

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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: immobilisation in a triangular sling Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Importance of Immobilisation After Intra-articular Glucocorticoid Treatment for Elbow Synovitis - a Randomised and Controlled Study
Study Start Date : January 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Relapse of Arthritis [ Time Frame: Regular visits at one week, 3 months and 6 months. ]
    The patients were followed for six months and if signs and symptoms recurred in between the patients were told to contact the rheumatology department. In such cases the elbow was re-examined and if a relapse could be confirmed the duration of effect was recorded and if needed the patient was offered another injection.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972530


Sponsors and Collaborators
Region Gävleborg
Meda AB
Investigators
Layout table for investigator information
Principal Investigator: Tomas Weitoft, MD PhD Department of Research and Development County Council of Gävleborg/Uppsala University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Region Gävleborg
ClinicalTrials.gov Identifier: NCT00972530    
Other Study ID Numbers: Dnr 2005:362
First Posted: September 7, 2009    Key Record Dates
Results First Posted: November 11, 2009
Last Update Posted: March 14, 2019
Last Verified: October 2009
Keywords provided by Region Gävleborg:
rheumatoid arthritis
treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases