The Effects of Low Intensity Ultrasound on Medial Tibial Cartilage Morphology in Patients With Mild or Moderate Knee Osteoarthritis: A Double Blind, Randomized Placebo-controlled Study.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- McMaster University
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Medial compartment knee cartilage thickness and volume
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to determine the effects of low intensity ultrasound therapy over the cartilage morphology (thickness and volume) of patients with mild or moderate knee osteoarthritis.
Detailed Description
Knee osteoarthritis (OA) negatively influences the healthy aging process of the population. Until today, there are no interventions that have proved effective for enhancing the cartilage regeneration of these patients. The use of Low Intensity Ultrasound (LIUS) therapy has demonstrated promising effects on cartilage regeneration in vitro and in vivo. The aim of this study was to assess the effects of 24 sessions of LIUS on the cartilage volume and thickness of patients with grades 1 and 2 (medial joint space narrowing OARSI atlas 2007) knee osteoarthritis (OA).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults ≥ 45 years old.
- •Fulfillment of the clinical / radiological diagnostic criteria proposed by Altman, et al. for knee osteoarthritis.
- •Medial Tibiofemoral Compartment joint space narrowing grades 1 OR 2 according to the OARSI atlas guide.
- •Ability to read and understand English questionnaires and follow instructions.
Exclusion Criteria
- •Presence of Metabolic related arthritis (calcium crystal deposition, hemochromatosis, acromegaly)
- •Arthritis related to trauma (major joint trauma, joint surgery)
- •Presence of inflammatory disorders (rheumatoid arthritis, ankylosing spondylitis, septic arthritis)
- •Previous surgical knee intervention
- •Intraarticular injection of the knee in the previous 6 months.
- •Presence of an unexpected traumatic episode in the affected knee (s) during the course of the study.
- •Any contraindication for X ray or peripheral MRI study.
Outcomes
Primary Outcomes
Medial compartment knee cartilage thickness and volume
Time Frame: Baseline and after completion of 24 sessions
A propietary software is been used to measure the cartilage thickness and volume of Magnetic Resonance Imaging obtained trough a coronal 3DGRE sequence. This measurement is been done by a trained physiatrist. The medial compartment is considered to be the primary outcome measure while the lateral compartment is considered as a secondary outcome.
Secondary Outcomes
- Patient´s global assessment of disease severity (Likert scale 0- 5)(Baseline and after completion of 24 sessions)
- Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)(Baseline and after completion of 24 sessions)
- Pain at the end of the 6 minute walk test(Baseline and after 24 US sessions)
- Lower Extremity Functional Scale (LEFS)(Baseline and after competion of 24 sessions.)
- 6 minutes walk test(Baseline and after completion of 24 sessions)
- Semi quantitative scoring of the knee joint(Baseline and after 24 sessions)