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

McMaster University

Status and phase: Completed; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Device: Sham Low intensity pulsed ultrasound therapy; Device: Low intensity pulsed ultrasound therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00931749

LIUSKOA-09-218

Details and patient eligibility

About

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.

Full 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).

Enrollment: 27 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups

Low intensity Ultrasound group

Experimental group

Treatment:

Device: Low intensity pulsed ultrasound therapy

Sham ultrasound group

Sham Comparator group

Treatment:

Device: Sham Low intensity pulsed ultrasound therapy