AzTrials
AzTrials

Knee OsteoarthritisPhase 2NCT00931749

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

A Phase 2 study testing Low intensity pulsed ultrasound therapy in people with Knee Osteoarthritis, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Low intensity pulsed ultrasound therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteCanada
Study dates
Sep 2009to Jun 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Hamilton, Ontario, L8S 4L8

Other trials in Canada

About this study

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.

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.

Read the 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).

Being tested
Low intensity pulsed ultrasound therapy, Sham Low intensity pulsed ultrasound therapy
Keywords
ultrasound therapy, knee cartilage thickness, knee cartilage volume, mild knee osteoarthritis, moderate knee osteoarthritis
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low intensity pulsed ultrasound therapyDevice

    Also called Ultrasound Unit. Intelect Mobile, Chattanooga Inc.

    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)

  • Sham Low intensity pulsed ultrasound therapyDevice

    Also called Ultrasound Unit. Intelect Mobile, Chattanooga Inc.

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

Study groups in NCT00931749
Study groupRoleWhat they receive
Low intensity Ultrasound groupExperimentalNot described
Receives: Device: Low intensity pulsed ultrasound therapy
Sham ultrasound groupSham comparatorNot described
Receives: Device: Sham Low intensity pulsed ultrasound therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and after completion of 24 sessions

Secondary outcomes (6)

  1. Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)

    The Likert 3.1 version of the scale will be used.

    Measured: Baseline and after completion of 24 sessions

  2. Lower Extremity Functional Scale (LEFS)

    The LEFS range from 0 (worst) to 80 (best)

    Measured: Baseline and after competion of 24 sessions.

  3. 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.

    Measured: Baseline and after completion of 24 sessions

  4. 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).

    Measured: Baseline and after completion of 24 sessions

  5. 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

    Measured: Baseline and after 24 sessions

  6. 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).

    Measured: Baseline and after 24 US sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionFeb 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00931749
Sponsor's protocol ID
LIUSKOA-09-218
Status last verified
Jun 2010
First submitted
1 Jul 2009
Last updated
9 Jun 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22200383

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low intensity pulsed ultrasound therapy in people with Knee Osteoarthritis, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medial compartment knee cartilage thickness and volume (time frame: Baseline and after completion of 24 sessions). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00931749, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in