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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
1 MHz, Spatial Average Intensity of 0.2 W /cm2, pulsed duty cycle 20%, 9.5 minutes, Therapeutic dose= 112.5 J/cm2. Fixed application on the medial side of the knee joint. Three sessions per week, during 2 months ( 24 sessions)
The Ultrasound device will not have the transducer´s crystal, so no ultrasonic energy will be provided.
School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University
Hamilton, Ontario, Canada
Medial compartment knee cartilage thickness and volume
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.
Time frame: Baseline and after completion of 24 sessions
Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)
The Likert 3.1 version of the scale will be used.
Time frame: Baseline and after completion of 24 sessions
Lower Extremity Functional Scale (LEFS)
The LEFS range from 0 (worst) to 80 (best)
Time frame: Baseline and after competion of 24 sessions.
6 minutes walk test
The test will be conducted on a flat surface-rectangular hallway by instructing the participants to "Cover as much as distance as possible in a comfortable pace", the distance will be measured with a mechanical road distance measuring wheel (The Measure Meter ®, Truemeter 5500, UK), and the time was set using the timer function on an ipod touch. Standardized encouragement "you are doing fine, just keep going" will be given every minute.
Time frame: Baseline and after completion of 24 sessions
Patient´s global assessment of disease severity (Likert scale 0- 5)
Patients' perceptions of their disease severity was measured by the question "Considering all the ways knee osteoarthritis affects you, how would you rate your condition today?" and a Likert scale ( 1-very poor, 2- poor, 3- fair, 4-good, 5- very good).
Time frame: Baseline and after completion of 24 sessions
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Semi quantitative scoring of the knee joint
A semi quantitative score of MRI features related to the OA process (cartilage grade of injury, bone marrow edema, subchondral cyst) for each compartment (medial and lateral) along with independent scores of the medial meniscus, lateral meniscus, and joint effusion will be made by a trained radiologist
Time frame: Baseline and after 24 sessions
Pain at the end of the 6 minute walk test
The level of pain at the end of the 6MT was recorded using a numeric pain scale ranging from 0 (no pain) to 10 (terrible pain).
Time frame: Baseline and after 24 US sessions