Daily Activity After Corticosteroids Injection Among Knee Osteoarthritis Patients

February 28, 2014 updated by: Philippe Corbeil, Laval University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 0A6
        • Pavillon de l'Éducation Physique et des Sports - Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injection
Corticosteroids injection
Drug: Corticosteroids injection
A solution of triamcinolone 40 mg (Kenalog) mixed with 3 cc of 2% xylocaine without epinephrine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Knee pain
Time Frame: Change from Baseline at 2, 4 and 6 weeks
Change from Baseline at 2, 4 and 6 weeks
Change in physical activity
Time Frame: Change from baseline at 2, 4 and 6 weeks
Change from baseline at 2, 4 and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in function and quality of life
Time Frame: Change from baseline at 2, 4 and 6 weeks
Assessment with WOMAC and MOS-SF36 questionnaires
Change from baseline at 2, 4 and 6 weeks
Change in Spatiotemporal gait parameters
Time Frame: Change from Baseline at 2, 4 and 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Study Director: Étienne Belzile, MD, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

March 3, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INF-2010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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