Clinical trial NCT06774469: Effect of Overdose Ultrasound on Osteoarthritic Knee in Adult Albino Rat: a Histological Study
Official title: Effect of Overdose Ultrasound on the Articular Cartilage of the Osteoarthritic Knee in Adult Albino Rat: a Histological Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis of Knee
Keywords: Osteoarthritis-ultrasound-overdose-albino rats-MIA-Articular cartilage
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 40
Sex: MALE
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Samples to estimate the knee cartilage thickness (femoral cartilage)
timeFrame: at the begginig of the experiment and at the end
measure: Samples to detect the morphology and the histological changes in cartilage matrix
timeFrame: at the begginig of the experiment and at the end
measure: Cellular changes
timeFrame: at the begginig of the experiment and at the end
measure: Inflammatory changes
timeFrame: at the begginig of the experiment and at the end
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Tanta University
name: Shereen Shawky Elabd, Assis. prof
role: STUDY_DIRECTOR
References: