Back to resultsEffects of Ultrasound Therapy on Cartilage Healing in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Low intensity pulsed ultrasound therapy
Sham Low intensity pulsed ultrasound therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring ultrasound therapy, knee cartilage thickness, knee cartilage volume, mild knee osteoarthritis, moderate knee osteoarthritis
Eligibility 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.
Sites / Locations
- School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Low intensity Ultrasound group
Sham ultrasound group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)
The Likert 3.1 version of the scale will be used.
Lower Extremity Functional Scale (LEFS)
The LEFS range from 0 (worst) to 80 (best)
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.
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).
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00931749
Brief Title
Effects of Ultrasound Therapy on Cartilage Healing in Patients With Knee Osteoarthritis
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 Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
McMaster University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
ultrasound therapy, knee cartilage thickness, knee cartilage volume, mild knee osteoarthritis, moderate knee osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low intensity Ultrasound group
Arm Type
Experimental
Arm Title
Sham ultrasound group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Low intensity pulsed ultrasound therapy
Other Intervention Name(s)
Ultrasound Unit. Intelect Mobile, Chattanooga Inc.
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Sham Low intensity pulsed ultrasound therapy
Other Intervention Name(s)
Ultrasound Unit. Intelect Mobile, Chattanooga Inc.
Intervention Description
The Ultrasound device will not have the transducer´s crystal, so no ultrasonic energy will be provided.
Primary Outcome Measure Information:
Title
Medial compartment knee cartilage thickness and volume
Description
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.
Time Frame
Baseline and after completion of 24 sessions
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)
Description
The Likert 3.1 version of the scale will be used.
Time Frame
Baseline and after completion of 24 sessions
Title
Lower Extremity Functional Scale (LEFS)
Description
The LEFS range from 0 (worst) to 80 (best)
Time Frame
Baseline and after competion of 24 sessions.
Title
6 minutes walk test
Description
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.
Time Frame
Baseline and after completion of 24 sessions
Title
Patient´s global assessment of disease severity (Likert scale 0- 5)
Description
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).
Time Frame
Baseline and after completion of 24 sessions
Title
Semi quantitative scoring of the knee joint
Description
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
Time Frame
Baseline and after 24 sessions
Title
Pain at the end of the 6 minute walk test
Description
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).
Time Frame
Baseline and after 24 US sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norma J MacIntyre, PhD
Organizational Affiliation
McMaster University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julie Richardson, PhD
Organizational Affiliation
McMaster University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karen Beattie, PhD
Organizational Affiliation
McMaster University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adalberto Loyola-Sanchez, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22200383
Citation
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.
Results Reference
derived
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Effects of Ultrasound Therapy on Cartilage Healing in Patients With Knee Osteoarthritis
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