Effects of Ultrasound Therapy on Cartilage Healing in Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Low intensity pulsed ultrasound therapy
* Device: Sham Low intensity pulsed ultrasound therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low intensity Ultrasound group<br> | Device: Low intensity pulsed ultrasound therapy<br>* 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)<br>* Other names: Ultrasound Unit. Intelect Mobile, Chattanooga Inc.;|
| Sham Comparator: Sham ultrasound group<br> | Device: Sham Low intensity pulsed ultrasound therapy<br>* The Ultrasound device will not have the transducer´s crystal, so no ultrasonic energy will be provided.<br>* Other names: Ultrasound Unit. Intelect Mobile, Chattanooga Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and after completion of 24 sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Osteoarthritis Index Score (WOMAC) | The Likert 3.1 version of the scale will be used. | Baseline and after completion of 24 sessions | 
| Lower Extremity Functional Scale (LEFS) | The LEFS range from 0 (worst) to 80 (best) | 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. | 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). | Baseline and after completion of 24 sessions | 
| 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 | 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). | Baseline and after 24 US sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound therapy, knee cartilage thickness, knee cartilage volume, mild knee osteoarthritis, moderate knee osteoarthritis