Intra-articular Glucocorticoid Treatment of the Elbow
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
immobilisation in a triangular sling
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, treatment
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Activity
immobilisation
Arm Description
Normal activity without restrictions
48 hours postinjection rest
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00972530
First Posted
September 3, 2009
Last Updated
February 18, 2019
Sponsor
Region Gävleborg
Collaborators
Meda AB
1. Study Identification
Unique Protocol Identification Number
NCT00972530
Brief Title
Intra-articular Glucocorticoid Treatment of the Elbow
Official Title
The Importance of Immobilisation After Intra-articular Glucocorticoid Treatment for Elbow Synovitis - a Randomised and Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Gävleborg
Collaborators
Meda AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activity
Arm Type
No Intervention
Arm Description
Normal activity without restrictions
Arm Title
immobilisation
Arm Type
Active Comparator
Arm Description
48 hours postinjection rest
Intervention Type
Behavioral
Intervention Name(s)
immobilisation in a triangular sling
Other Intervention Name(s)
Postinjection rest, normal joint usage
Intervention Description
Intervention group: Immobilisation 48 hours in a triangular sling (mitella)
Control group: normal activity without restrictions
Primary Outcome Measure Information:
Title
Relapse of Arthritis
Description
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.
Time Frame
Regular visits at one week, 3 months and 6 months.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Weitoft, MD PhD
Organizational Affiliation
Department of Research and Development County Council of Gävleborg/Uppsala University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20461791
Citation
Weitoft T, Forsberg C. Importance of immobilization after intraarticular glucocorticoid treatment for elbow synovitis: a randomized controlled study. Arthritis Care Res (Hoboken). 2010 May;62(5):735-7. doi: 10.1002/acr.20039.
Results Reference
derived
Learn more about this trial
Intra-articular Glucocorticoid Treatment of the Elbow
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