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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low intensity Ultrasound group | Experimental |
| |
| Sham ultrasound group | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity pulsed ultrasound therapy | Device | 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) |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norma J MacIntyre, PhD | McMaster University | Study Director |
| Julie Richardson, PhD | McMaster University | Study Chair |
| Karen Beattie, PhD | McMaster University | Study Chair |
| Adalberto Loyola-Sanchez, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University | Hamilton | Ontario | L8S 4L8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22200383 | Derived | Loyola-Sanchez A, Richardson J, Beattie KA, Otero-Fuentes C, Adachi JD, MacIntyre NJ. Effect of low-intensity pulsed ultrasound on the cartilage repair in people with mild to moderate knee osteoarthritis: a double-blinded, randomized, placebo-controlled pilot study. Arch Phys Med Rehabil. 2012 Jan;93(1):35-42. doi: 10.1016/j.apmr.2011.07.196. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Sham Low intensity pulsed ultrasound therapy | Device | The Ultrasound device will not have the transducer´s crystal, so no ultrasonic energy will be provided. |
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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 |
| D012216 |
| Rheumatic Diseases |