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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00931749 |
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Date of registration:
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01/07/2009 |
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Primary sponsor: |
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Public title:
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Effects of Ultrasound Therapy on Cartilage Healing in Patients With Knee Osteoarthritis
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Scientific 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. |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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27 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00931749 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Adalberto Loyola-Sanchez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Name:
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Julie Richardson, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Name:
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Karen Beattie, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Name:
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Norma J MacIntyre, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Key inclusion & exclusion 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.
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Knee Osteoarthritis
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Intervention(s)
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Device: Low intensity pulsed ultrasound therapy
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Device: Sham Low intensity pulsed ultrasound therapy
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Primary Outcome(s)
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Medial compartment knee cartilage thickness and volume
[Time Frame: Baseline and after completion of 24 sessions]
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Secondary Outcome(s)
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6 minutes walk test
[Time Frame: Baseline and after completion of 24 sessions]
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Lower Extremity Functional Scale (LEFS)
[Time Frame: Baseline and after competion of 24 sessions.]
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Pain at the end of the 6 minute walk test
[Time Frame: Baseline and after 24 US sessions]
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Patient´s global assessment of disease severity (Likert scale 0- 5)
[Time Frame: Baseline and after completion of 24 sessions]
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Semi quantitative scoring of the knee joint
[Time Frame: Baseline and after 24 sessions]
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Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)
[Time Frame: Baseline and after completion of 24 sessions]
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Secondary ID(s)
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LIUSKOA-09-218
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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