Intra-articular Glucocorticoid Treatment of the Elbow

Rheumatoid Arthritis Clinical Trial

Official title:

The Importance of Immobilisation After Intra-articular Glucocorticoid Treatment for Elbow Synovitis - a Randomised and Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972530
• Other study ID #: Dnr 2005:362
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: October 2009
• Source: Region Gävleborg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• immobilisation in a triangular sling
Intervention group: Immobilisation 48 hours in a triangular sling (mitella) Control group: normal activity without restrictions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Region Gävleborg	Meda AB

Outcome

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.