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

NCT00931749 | Completed Phase 2

• 1 other identifier: LIUSKOA-09-218
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

ultrasound therapy; knee cartilage thickness; knee cartilage volume; mild knee osteoarthritis; moderate knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)

  Baseline and after completion of 24 sessions

• Lower Extremity Functional Scale (LEFS)

  Baseline and after competion of 24 sessions.

• 6 minutes walk test

  Baseline and after completion of 24 sessions

• Patient´s global assessment of disease severity (Likert scale 0- 5)

  Baseline and after completion of 24 sessions

• Semi quantitative scoring of the knee joint

  Baseline and after 24 sessions

Study Arms (2)

Low intensity Ultrasound group

EXPERIMENTAL

Device: Low intensity pulsed ultrasound therapy

Sham ultrasound group

SHAM COMPARATOR

Device: Sham Low intensity pulsed ultrasound therapy

Interventions

Low intensity pulsed ultrasound therapy DEVICE

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)

Also known as: Ultrasound Unit. Intelect Mobile, Chattanooga Inc.

Low intensity Ultrasound group

Sham Low intensity pulsed ultrasound therapy DEVICE

The Ultrasound device will not have the transducer´s crystal, so no ultrasonic energy will be provided.

Also known as: Ultrasound Unit. Intelect Mobile, Chattanooga Inc.

Sham ultrasound group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

School of Rehabilitation Science, Institute of Applied Health Sciences, McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (1)

• 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.

  PMID: 22200383 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Norma J MacIntyre, PhD

  McMaster University

  STUDY DIRECTOR

• Julie Richardson, PhD

  McMaster University

  STUDY CHAIR

• Karen Beattie, PhD

  McMaster University

  STUDY CHAIR

• Adalberto Loyola-Sanchez, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: September 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 9, 2010

Record last verified: 2010-06

Locations

CA (1)