Intra-articular Glucocorticoid Treatment of the Elbow

NCT ID: NCT00972530

Last Updated: 2019-03-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Activity

Normal activity without restrictions

Group Type NO_INTERVENTION

No interventions assigned to this group

immobilisation

48 hours postinjection rest

Group Type ACTIVE_COMPARATOR

immobilisation in a triangular sling

Intervention Type BEHAVIORAL

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

Control group: normal activity without restrictions

Interventions

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immobilisation in a triangular sling

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

Control group: normal activity without restrictions

Intervention Type BEHAVIORAL

Other Intervention Names

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Postinjection rest normal joint usage

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meda AB

UNKNOWN

Sponsor Role collaborator

Region Gävleborg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomas Weitoft, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Research and Development County Council of Gävleborg/Uppsala University

References

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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.

Reference Type DERIVED
PMID: 20461791 (View on PubMed)

Other Identifiers

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Dnr 2005:362

Identifier Type: -

Identifier Source: org_study_id

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