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临床试验/NCT03705039
NCT03705039已完成不适用

Assessing the Effects of Pulsed Ultrasound Treatment on Pain, Functionality, Synovial Fluid and Cartilage Thickness, in Knee Osteoarthritis

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
Amount of synovial fluid

研究概览

简要总结

Osteoarthritis is a progressive rheumatic disease which is the most common cause of musculoskeletal pain and functional impairment, particularly in the elderly group. The most common form is knee osteoarthritis. Pharmacological, non-pharmacological and if required surgical treatment may be applied in the osteoarthritis treatment. Non-pharmacological treatment includes patient education, joint protective measures, exercise, psychological support, diet, weight loss, physical therapy modalities, use of assistive device, hydrotherapy and balneotherapy. Ultrasound therapy is one of the most commonly used physical modalities in osteoarthritis treatment. İt has a deep heating effect and increases tissue regeneration, blood flow and metabolic effects while reducing the inflammation and relaxing the muscles. İn addition, it increases the cartilage regeneration according to certain in vivo and in vitro studies.

Decelerating the cartilage loss and decreasing the high volume of synovial fluid in early-stage knee osteoarthritis is important to preventing progression of the disease. Although there are some randomised controlled clinical trials that prove the effect of ultrasound treatment on pain and functionality in the knee osteoarthritis, there is no study that proves the effect of ultrasound treatment on cartilage thickness and synovial fluid amount. The aim of this study is evaluating the effect of pulsed ultrasound treatment on cartilage regeneration, inflammation and quality of life in the volunteers diagnosed knee osteoarthritis. This study is unique because it is the first study that evaluates the effect of therapeutic pulsed ultrasound on synovial fluid and cartilage thickness with ultrasonography.

详细描述

The study is a randomised, controlled and parallel group study. 96 patients will be included to study who apply to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic with the complaint of knee pain, aged between 45-75 years. Patients also have diagnosed as knee osteoarthritis according to American College of Rheumatology (ACR) diagnostic criteria and Kellgren-Lawrence grades are ≤3. These patients will be divided into two groups randomly (Treatment group n:48, control group n:48). The patients in the treatment group will receive treatment with 1 MHz probe with the intensity of 1w/cm2, pulsed at a ratio of 1:4 for 10 minutes and at an interval of 3 sessions per week for 8 weeks, a total of 24 sessions. On the other hand, sham US will be applied to control group for the same times and periods as the treatment group. A home exercise program will be given to both of two groups which contain knee range of motion and isometric strengthening exercises. The patients will be allowed to take paracetamol only when they complain of pain. All patients will be evaluated for 3 times, before and after treatment and 3 months after the treatment with ultrasonographic measurements and life quality tests. Primary aim of this study is to evaluate the effect of pulsed ultrasound on amount of synovial fluid and cartilage thickness.

For this purpose, cartilage thickness and reduction in the amount of synovial fluid will be measured via ultrasound.

Secondary aim is evaluating the effect of pulsed ultrasound on quality of life. Knee pain will be measured by VAS (Visual analogue scale) and functionality will be measured by WOMAC survey and Timed Up and Go Test.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Complain of knee pain
  • Aged between 45-75 years
  • Diagnosed as knee osteoarthritis according to American College of Rheumatology (ACR) diagnostic criteria and Kellgren-Lawrence grades are ≤3

排除标准

  • Infection
  • Arthritis
  • Using corticosteroids
  • Corticosteroid injections
  • Neurological deficit
  • History of knee surgery
  • Central and peripheral nerve diseases
  • Pregnancy
  • Malignancy

结局指标

主要结局

Amount of synovial fluid

时间窗: Change from Baseline Amount of synovial fluid at 12 weeks

The amount of synovial fluid will be measured via ultrasonography in knee

次要结局

  • Function(All patients will be evaluated for 3 times at baseline and week 8 and week 12)
  • time up and go(All patients will be evaluated for 3 times at baseline and week 8 and week 12)
  • cartilage thickness in knee(All patients will be evaluated for 3 times at baseline and week 8 and week 12)
  • Knee Pain: VAS(All patients will be evaluated for 3 times, at baseline and week 8 and week 12.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Banu Dilek

Principal investigator

Dokuz Eylul University

研究点 (2)

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