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Completed

NCT Number: NCT02049879

Daily Activity After Corticosteroids Injection Among Knee Osteoarthritis Patients

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corticosteroids injection

Drug

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

Primary outcomes

  1. Change in Knee pain

    Time frame: Change from Baseline at 2, 4 and 6 weeks

  2. Change in physical activity

    Time frame: Change from baseline at 2, 4 and 6 weeks

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 30, 2014
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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