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

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00931749
First received: July 1, 2009
Last updated: June 8, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Knee Osteoarthritis
Device: Low intensity pulsed ultrasound therapy
Device: Sham Low intensity pulsed ultrasound therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Medial compartment knee cartilage thickness and volume [ Time Frame: Baseline and after completion of 24 sessions ] [ Designated as safety issue: No ]
    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:
  • Western Ontario and McMaster Osteoarthritis Index Score (WOMAC) [ Time Frame: Baseline and after completion of 24 sessions ] [ Designated as safety issue: No ]
    The Likert 3.1 version of the scale will be used.

  • Lower Extremity Functional Scale (LEFS) [ Time Frame: Baseline and after competion of 24 sessions. ] [ Designated as safety issue: No ]
    The LEFS range from 0 (worst) to 80 (best)

  • 6 minutes walk test [ Time Frame: Baseline and after completion of 24 sessions ] [ Designated as safety issue: No ]
    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.

  • Patient´s global assessment of disease severity (Likert scale 0- 5) [ Time Frame: Baseline and after completion of 24 sessions ] [ Designated as safety issue: No ]
    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).

  • Semi quantitative scoring of the knee joint [ Time Frame: Baseline and after 24 sessions ] [ Designated as safety issue: No ]
    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

  • Pain at the end of the 6 minute walk test [ Time Frame: Baseline and after 24 US sessions ] [ Designated as safety issue: No ]
    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).


Enrollment: 27
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931749

Locations
Canada, Ontario
School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University
Hamilton, Ontario, Canada, L8S 4L8
Sponsors and Collaborators
McMaster University
Investigators
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
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adalberto Loyola-Sanchez/ MSc on Rehabilitation Sciences candidate, McMaster University
ClinicalTrials.gov Identifier: NCT00931749     History of Changes
Other Study ID Numbers: LIUSKOA-09-218
Study First Received: July 1, 2009
Last Updated: June 8, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
ultrasound therapy
knee cartilage thickness
knee cartilage volume
mild knee osteoarthritis
moderate knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014