Clinical trial NCT00931749: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Keywords: ultrasound therapy
knee cartilage thickness
knee cartilage volume
mild knee osteoarthritis
moderate knee osteoarthritis
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 27
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Medial compartment knee cartilage thickness and volume
timeFrame: Baseline and after completion of 24 sessions
Secondary outcomes:
measure: Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)
timeFrame: Baseline and after completion of 24 sessions
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Baseline and after competion of 24 sessions.
measure: 6 minutes walk test
timeFrame: Baseline and after completion of 24 sessions
measure: Patient´s global assessment of disease severity (Likert scale 0- 5)
timeFrame: Baseline and after completion of 24 sessions
measure: Semi quantitative scoring of the knee joint
timeFrame: Baseline and after 24 sessions
measure: Pain at the end of the 6 minute walk test
timeFrame: Baseline and after 24 US sessions
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Norma J MacIntyre, PhD
role: STUDY_DIRECTOR
affiliation: McMaster University
name: Julie Richardson, PhD
role: STUDY_CHAIR
affiliation: McMaster University
name: Karen Beattie, PhD
role: STUDY_CHAIR
affiliation: McMaster University
name: Adalberto Loyola-Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.