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NCT Number: NCT00931749

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University

Hamilton, Ontario, L8S 4L8, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: Ultrasound Unit. Intelect Mobile, Chattanooga Inc.

Sham Low intensity pulsed ultrasound therapy

Device

The Ultrasound device will not have the transducer´s crystal, so no ultrasonic energy will be provided.

Other names: Ultrasound Unit. Intelect Mobile, Chattanooga Inc.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 2, 2009
Registry last updated
Jun 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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