NCT02049879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
Last Updated

March 3, 2014

Status Verified

February 1, 2014

Enrollment Period

3.8 years

First QC Date

January 28, 2014

Last Update Submit

February 28, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Knee pain

    Change from Baseline at 2, 4 and 6 weeks

  • Change in physical activity

    Change from baseline at 2, 4 and 6 weeks

Secondary Outcomes (2)

  • Change in function and quality of life

    Change from baseline at 2, 4 and 6 weeks

  • Change in Spatiotemporal gait parameters

    Change from Baseline at 2, 4 and 6 weeks

Study Arms (1)

Injection

EXPERIMENTAL

Corticosteroids injection

Drug: Corticosteroids injection

Interventions

A solution of triamcinolone 40 mg (Kenalog) mixed with 3 cc of 2% xylocaine without epinephrine.

Injection

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or more
  • Medial knee osteoarthritis (Kellgren \& Lawrence Grade I to III)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Philippe Corbeil, PhD

    Laval University

    STUDY DIRECTOR
  • Yoann Dessery, MSc

    Laval University

    PRINCIPAL INVESTIGATOR
  • Étienne Belzile, MD

    Laval University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

November 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 3, 2014

Record last verified: 2014-02

Locations