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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Medial compartment knee cartilage thickness and volume
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Medial compartment knee cartilage thickness and volume
时间窗: 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.
次要结局
- Patient´s global assessment of disease severity (Likert scale 0- 5)(Baseline and after completion of 24 sessions)
- Western Ontario and McMaster Osteoarthritis Index Score (WOMAC)(Baseline and after completion of 24 sessions)
- Pain at the end of the 6 minute walk test(Baseline and after 24 US sessions)
- Lower Extremity Functional Scale (LEFS)(Baseline and after competion of 24 sessions.)
- 6 minutes walk test(Baseline and after completion of 24 sessions)
- Semi quantitative scoring of the knee joint(Baseline and after 24 sessions)