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

Phase 2

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: Low intensity pulsed ultrasound therapy; Device: Sham Low intensity pulsed ultrasound therapy

• Registration Number: NCT00931749
• Lead Sponsor: McMaster University

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).

Study Timeline

• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-02
• Study Start: 2009-09
• Primary Completion: 2010-02
• Status Verified: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-08
• Last Update Posted: 2010-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low intensity Ultrasound group	Low intensity pulsed ultrasound therapy	-
Sham ultrasound group	Sham Low intensity pulsed ultrasound therapy	-

Primary Outcome Measures

Name	Time	Method
Medial compartment knee cartilage thickness and volume	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 Outcome Measures

Name	Time	Method
Patient´s global assessment of disease severity (Likert scale 0- 5)	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).
Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)	Baseline and after completion of 24 sessions	The Likert 3.1 version of the scale will be used.
Pain at the end of the 6 minute walk test	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).
Lower Extremity Functional Scale (LEFS)	Baseline and after competion of 24 sessions.	The LEFS range from 0 (worst) to 80 (best)
6 minutes walk test	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.
Semi quantitative scoring of the knee joint	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

Trial Locations

Locations (1)

School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University; 🇨🇦 Hamilton, Ontario, Canada