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Daily Activity After Corticosteroids Injection Among Knee Osteoarthritis Patients

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Corticosteroids injection
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

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

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

Sites / Locations

  • Pavillon de l'Éducation Physique et des Sports - Université Laval

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Injection

Arm Description

Corticosteroids injection

Outcomes

Primary Outcome Measures

Change in Knee pain
Change in physical activity

Secondary Outcome Measures

Change in function and quality of life
Assessment with WOMAC and MOS-SF36 questionnaires
Change in Spatiotemporal gait parameters
Gait symmetry was verified with regards to the swing and stance phase durations and step length

Full Information

First Posted
January 28, 2014
Last Updated
February 28, 2014
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT02049879
Brief Title
Daily Activity After Corticosteroids Injection Among Knee Osteoarthritis Patients
Official Title
Quantification of Daily Physical Activity After an Intra-articular Corticosteroid Injection in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection
Arm Type
Experimental
Arm Description
Corticosteroids injection
Intervention Type
Drug
Intervention Name(s)
Corticosteroids injection
Intervention Description
A solution of triamcinolone 40 mg (Kenalog) mixed with 3 cc of 2% xylocaine without epinephrine.
Primary Outcome Measure Information:
Title
Change in Knee pain
Time Frame
Change from Baseline at 2, 4 and 6 weeks
Title
Change in physical activity
Time Frame
Change from baseline at 2, 4 and 6 weeks
Secondary Outcome Measure Information:
Title
Change in function and quality of life
Description
Assessment with WOMAC and MOS-SF36 questionnaires
Time Frame
Change from baseline at 2, 4 and 6 weeks
Title
Change in Spatiotemporal gait parameters
Description
Gait symmetry was verified with regards to the swing and stance phase durations and step length
Time Frame
Change from Baseline at 2, 4 and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Corbeil, PhD
Organizational Affiliation
Laval University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yoann Dessery, MSc
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Étienne Belzile, MD
Organizational Affiliation
Laval University
Official's Role
Study Director
Facility Information:
Facility Name
Pavillon de l'Éducation Physique et des Sports - Université Laval
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25478585
Citation
Dessery Y, Belzile EL, Turmel S, Dore J, Diallo B, Corbeil P. Modulation of physical activity to optimize pain sensation following an intra-articular corticosteroid injection in patients with knee osteoarthritis. ScientificWorldJournal. 2014;2014:209165. doi: 10.1155/2014/209165. Epub 2014 Nov 16.
Results Reference
derived

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Daily Activity After Corticosteroids Injection Among Knee Osteoarthritis Patients

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