跳至主要内容
临床试验/NCT06774469
NCT06774469进行中(未招募)不适用

Effect of Overdose Ultrasound on the Articular Cartilage of the Osteoarthritic Knee in Adult Albino Rat: a Histological Study

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Samples to estimate the knee cartilage thickness (femoral cartilage)

研究概览

简要总结

The purpose of this study is to investigate the effect of overdose ultrasound on the articular cartilage of the osteoarthritic knee in adult albino rate. The US is considered the most popular and effective treatment for osteoarthritis as it can penetrate deep tissue reaching internal structures which allow it to be effective for osteoarthritis treatment. Previous researches apply US as a treatment for different cases with different intensity and repetition, but no one has actually proven the frequency of this use or the effect of excess use on cells, so the investigators need evidence to determine the optimum therapeutic dose and frequent repetition which should determine the effect of more than one session on the joint cartilage and cells and if it has a positive or negative effect and this is the main goal in this study which is limited in all studies concerning the US.

详细描述

Because many patients suffer from osteoarthritis and this work may help for treatment those patients. The US is considered the most popular and effective treatment for osteoarthritis as it can penetrate deep tissue reaching internal structures which allow to be effective for osteoarthritis treatment, also improves the cellular function by making microscopic gas bubbles near to the site of injury expand and contract rapidly, a process called cavitation. This process is thought to speed up the healing process in the injured body part. Previous researches apply US as a treatment for different cases with different intensity and repetition, but no one has actually proven the frequency of this use or the effect of excess use on cells, so the investigators need evidence to determine the optimum therapeutic dose and frequent repetition which should determine the effect of this repetition on the joints and cells and if has a positive or negative effect and this is the main goal in this study which is limited in all studies concerning the US in addition to previous systematic reviews regarding its effectiveness on KOA are outdated, and the latest reviews presented methodological limitations, such as the inclusion of mixed interventions, that hindered the evidence synthesis, and the inclusion of pulsed US (low-intensity) only.

The Investigators want to perform a more focused and comprehensive evidence synthesis targeting the isolated effects of the therapeutic US and specially the overdose to more clearly define its contributing role as an adjuvant treatment in rehabilitative regimens for KOA. Therefore studies worked on the effect of ultrasound on the knee cartilage especially femoral cartilage, the degradation and destruction of the femoral articular cartilage demonstrated a greater degree of deterioration than those of the tibial and patellar articular cartilage, and on some specific changes within its cells like apoptosis neglecting other cellular or matrix changes which may be affected by the destruction of articular cartilage and it's the second aim in this study. Although the results of previous studies suggest that US is a safe non-pharmacological treatment option that may provide additional pain relief and functional improvement in addition to cartilage repair with different parameters of US, no research assessing dosing regimen repetition to investigate its overdose effect on tissues and this was not reasonable to perform these analyses based on overdose on humans. This is the topic for the research, because the optimum therapeutic dose of therapeutic US is debated in previous research.

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
Single (Participant)

盲法说明

40 rats

入排标准

年龄范围
7 Weeks 至 8 Weeks(Child)
性别
Male
接受健康志愿者
是

入选标准

  • •Forty male Albino rats will be used for the study of knee osteoarthritis.
  • •At 7-8 weeks of age.
  • •200-250 grams in weight will be obtained from the animal facility of the histology department, Faculty of Medicine, Tanta University.

排除标准

  • •Weight < 200-250 > kg.
  • •Rats with injured thighs and/or knees.
  • •Female rats.

研究组 & 干预措施

G1 (Control group)

Sham Comparator

(Normal group) For studying the normal histological structure of the articular knee joint. Will be assessed at the beginning of the study

干预措施: ultrasound (Device)

G2 expermintal

Experimental

(Normal-US Group) Will be assessed after 30 consequent days

干预措施: assigned (Device)

G3 expermintal

Experimental

(Osteoarthritis-induced group)Will be assessed after 14 days

干预措施: Injection, Solution (Drug)

G4 expermintal

Experimental

(Osteoarthritis-Recovery group): Will be assessed after44 days

干预措施: Injection, Solution (Drug)

G5 experimental

Experimental

(Osteoarthritis-US group) Will be assessed after 44 days

干预措施: assigned (Device)

结局指标

主要结局

Samples to estimate the knee cartilage thickness (femoral cartilage)

时间窗: at the begginig of the experiment and at the end

captured by a microscope camera and analyzed using the Image J software (https://imagej.en.softonic.com) .

Samples to detect the morphology and the histological changes in cartilage matrix

时间窗: at the begginig of the experiment and at the end

Matrix changes can be detected by using different histochemical stains as a trichrome stain for the demonstration of collagen fibers and a combination of Van Gieson and Safranin O stains

Cellular changes

时间窗: at the begginig of the experiment and at the end

by studying and analyzing the hematoxylin and eosin stained section by using different lens powers of microscope.

Inflammatory changes

时间窗: at the begginig of the experiment and at the end

by immunohistochemical stains of CD markers according to the availability (either INOS or NF-KB).

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

Shahenda Mohamed Eissa

physiotherapist specialist

Cairo University

研究点 (1)

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