Intra-articular Glucocorticoid Treatment of the Elbow

NCT00972530 | Completed Results

• 1 other identifier: Dnr 2005:362
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; treatment

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Activity

NO INTERVENTION

Normal activity without restrictions

immobilisation

ACTIVE COMPARATOR

48 hours postinjection rest

Behavioral: immobilisation in a triangular sling

Interventions

immobilisation in a triangular sling BEHAVIORAL

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

Also known as: Postinjection rest, normal joint usage

immobilisation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Rheumatoid arthritis, and
• Clinical signs of elbow synovitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Gävleborg: lead
• Meda AB: collaborator

Related Publications (1)

• 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.

  PMID: 20461791 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr Tomas Weitoft
• Organization: Department of Research and Development County Council of Gavleborg/Uppsala University

tomas.weitoft@lg.se

+46 26 154388

Study Officials

• Tomas Weitoft, MD PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 7, 2009
• Study Start: January 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 14, 2019
• Results First Posted: November 11, 2009

Record last verified: 2009-10