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

Knee Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931749
• Other study ID #: LIUSKOA-09-218
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2009
• Last updated: June 8, 2010
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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)
• Sham Low intensity pulsed ultrasound therapy
The Ultrasound device will not have the transducer´s crystal, so no ultrasonic energy will be provided.

Locations

Country	Name	City	State
Canada	School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and after completion of 24 sessions	No
Secondary	Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)	The Likert 3.1 version of the scale will be used.	Baseline and after completion of 24 sessions	No
Secondary	Lower Extremity Functional Scale (LEFS)	The LEFS range from 0 (worst) to 80 (best)	Baseline and after competion of 24 sessions.	No
Secondary	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.	Baseline and after completion of 24 sessions	No
Secondary	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).	Baseline and after completion of 24 sessions	No
Secondary	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	Baseline and after 24 sessions	No
Secondary	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).	Baseline and after 24 US sessions	No