Daily Activity After Corticosteroids Injection Among Knee Osteoarthritis Patients

Knee Osteoarthritis Clinical Trial

Official title:

Quantification of Daily Physical Activity After an Intra-articular Corticosteroid Injection in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049879
• Other study ID #: INF-2010
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2014
• Last updated: February 28, 2014
• Start date: November 2008
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to objectively measure daily physical activity and spatiotemporal gait pattern, as well as improvements in self reported symptoms and quality of life, before and six weeks after an intra-articular corticosteroids injection in patients suffering from knee osteoarthritis. Fourteen patients with unilateral knee osteoarthritis were recruited. The intra-articular corticosteroid injection was given at the end of the second week. Physical activity was objectively measured by an accelerometer worn by the participants for eight weeks. In addition, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Medical Outcome Study Short Form-36 (MOS-SF36) and gait trials were completed every two weeks to assess symptoms, quality of life and spatiotemporal parameters of gait.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 50 years old or more

• Medial knee osteoarthritis (Kellgren & Lawrence Grade I to III)

Exclusion Criteria:

• Intra-articular injection during the last six months

• Isolated femoro-patellar arthritis

• Rheumatoid arthritis

• Knee instability

• Spinal stenosis

• Lower limb fracture over the last year

• Lower limb surgery in the last three months

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Corticosteroids injection
A solution of triamcinolone 40 mg (Kenalog) mixed with 3 cc of 2% xylocaine without epinephrine.

Locations

Country	Name	City	State
Canada	Pavillon de l'Éducation Physique et des Sports - Université Laval	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knee pain		Change from Baseline at 2, 4 and 6 weeks	No
Primary	Change in physical activity		Change from baseline at 2, 4 and 6 weeks	No
Secondary	Change in function and quality of life	Assessment with WOMAC and MOS-SF36 questionnaires	Change from baseline at 2, 4 and 6 weeks	No
Secondary	Change in Spatiotemporal gait parameters	Gait symmetry was verified with regards to the swing and stance phase durations and step length	Change from Baseline at 2, 4 and 6 weeks	No