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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
Region Gävleborg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 3, 2009
    Last Updated
    February 18, 2019
    Sponsor
    Region Gävleborg
    Collaborators
    Meda AB
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    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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