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临床试验/NCT03913052
NCT03913052Unknown不适用

A Research on The Effects of Intra-articular Viscosupplement Application Containing Hyaluronic Acid, Chondroitin Sulfate and Glucosamine Compounds on the Isokinetic Muscle Test Values of Patients With 40-65 Years of Knee Osteoarthritis

Istanbul Bilgi University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
15
试验地点
2
主要终点
Biodex (System 3) isokinetic systems

研究概览

简要总结

Knee osteoarthritis (OA) is one of the common diseases which causes pain and disability with increasing age. In developed countries, it is said to be one of the ten diseases which decreases functionality most.

详细描述

Knee osteoarthritis (OA) is one of the common diseases which causes pain and disability with increasing age. In developed countries, it is said to be one of the ten diseases which decreases functionality most. With a prevalence between 22% - 39%, 7% of which are patients who are over 65 years old, and when examined world-wide, it is stated that knee OA is seen 18% of women and 9,6% of men. Knee OA is characterized by pain, and; functional loss and progressive mobility where motions are required a physical activity of lower extremity. The disease causes 80% of restriction of motions and 25% of restriction of daily life activities. Additionally, along with the loss of proprioception, it can be seen defects of static and dynamic postural stability and the loss of balance. The factors of disease cause reduced muscle strength, defects of functionality of muscles and reduced workout capacity. According to the radiographic classification of Kellgren and Lawrence, quadriceps muscle weakness is frequently seen without atrophy and pain in early phases of knee OA of which degree is 0 or 1. If the symptoms are accompanied by a knee pain, the weakness of muscles will show an increase more and cause dysfunction and progression of disease. An increase of force in the muscles of quadriceps and hamstring plays a positive role for stability and mobility of joints and pain tolerance.

In the literature, studies with intra-articular HA injection in the treatment of knee OA are frequently seen, but the number of studies about the co-injection of HA, CS and GA is scarcely any. At the same time, studies investigating the effect of intra-articular viscosupplementation injection on isokinetic muscle strength was not observed. Therefore, the investigators aimed at investigating the effects of HA, CS and GA injection on isokinetic quadriceps and hamstring muscle strengths in our study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • being between 40-65 years of age,
  • being diagnosed with Stage 3 and 4 knee OA according to the Kellgren-Lawrence classification

排除标准

  • any lower extremity deformity (knee flexion contracture, knee hyperextension, varus and valgus deformities),
  • septic arthritis, rheumatoid arthritis,
  • major dysplasia,
  • congenital anomalies, acromegaly, primary osteochondromatosis,
  • Ehler-Danlos syndrome,
  • neuropathic arthropathy,
  • hyperparathyroidism, hypothyroidism,
  • diabetes mellitus,
  • active synovitis,
  • severe knee traumas,
  • previous surgery and in the last year,
  • knee arthroscopy, injections and fracture history and pregnancy

研究组 & 干预措施

Injection

Experimental

Injection containing hyaluronic acid, chondroitin sulphate and glucosamine was performed once when the knee joint was in the supine position and the knee was in the extension.

干预措施: Intra-articular Viscosupplement Application (Procedure)

结局指标

主要结局

Biodex (System 3) isokinetic systems

时间窗: 5 minutes

Isokinetic test are measured with Biodex (System 3) for the measurement of quadriceps muscle strength before and 3 months after injection. Measurements are performed at angular speeds of 60°. Biodex (System 3) isokinetic systems are used to evaluate knee flexion angles and the muscle strengths applied at these angular velocities. The device is set to measure at angular speeds of 60°. Knee extension and flexion are requested and the best measurement is made. By this measurement, the effect of injection on quadriceps isokinetic muscle strength will be determined.

次要结局

未报告次要终点

研究者

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

TOMRIS DUYMAZ

Asst. Prof. Ph.D.

Istanbul Bilgi University

研究点 (2)

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