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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931749
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : June 9, 2010
Information provided by:
McMaster University

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Low intensity pulsed ultrasound therapy Device: Sham Low intensity pulsed ultrasound therapy Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Low intensity Ultrasound group Device: Low intensity pulsed ultrasound therapy
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)
Other Name: Ultrasound Unit. Intelect Mobile, Chattanooga Inc.

Sham Comparator: Sham ultrasound group Device: Sham Low intensity pulsed ultrasound therapy
The Ultrasound device will not have the transducer´s crystal, so no ultrasonic energy will be provided.
Other Name: Ultrasound Unit. Intelect Mobile, Chattanooga Inc.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Western Ontario and McMaster Osteoarthritis Index Score (WOMAC) [ Time Frame: Baseline and after completion of 24 sessions ]
    The Likert 3.1 version of the scale will be used.

  2. Lower Extremity Functional Scale (LEFS) [ Time Frame: Baseline and after competion of 24 sessions. ]
    The LEFS range from 0 (worst) to 80 (best)

  3. 6 minutes walk test [ Time Frame: Baseline and after completion of 24 sessions ]
    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.

  4. Patient´s global assessment of disease severity (Likert scale 0- 5) [ Time Frame: Baseline and after completion of 24 sessions ]
    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).

  5. Semi quantitative scoring of the knee joint [ Time Frame: Baseline and after 24 sessions ]
    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

  6. Pain at the end of the 6 minute walk test [ Time Frame: Baseline and after 24 US sessions ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00931749

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Canada, Ontario
School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University
Hamilton, Ontario, Canada, L8S 4L8
Sponsors and Collaborators
McMaster University
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Study Director: Norma J MacIntyre, PhD McMaster University
Study Chair: Julie Richardson, PhD McMaster University
Study Chair: Karen Beattie, PhD McMaster University
Principal Investigator: Adalberto Loyola-Sanchez, MD McMaster University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Adalberto Loyola-Sanchez/ MSc on Rehabilitation Sciences candidate, McMaster University Identifier: NCT00931749    
Other Study ID Numbers: LIUSKOA-09-218
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010
Keywords provided by McMaster University:
ultrasound therapy
knee cartilage thickness
knee cartilage volume
mild knee osteoarthritis
moderate knee osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases