Rheumatoid Arthritis Clinical Trial
Official title:
The Importance of Immobilisation After Intra-articular Glucocorticoid Treatment for Elbow Synovitis - a Randomised and Controlled Study
NCT number | NCT00972530 |
Other study ID # | Dnr 2005:362 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2006 |
Est. completion date | December 2008 |
Verified date | October 2009 |
Source | Region Gävleborg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Region Gävleborg | Meda AB |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relapse of Arthritis | 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. | Regular visits at one week, 3 months and 6 months. |
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