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

Cairo University (CU)

Status: Active, not recruiting

Conditions: Osteoarthritis of Knee

Treatments: Device: assigned; Drug: Injection, Solution; Device: ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06774469

cu III F 89 23

Details and patient eligibility

About

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.

Full 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in all studies concerning the US in addition to previous systematic reviews regarding its effectiveness on KOA are outdated, and the latest reviews presented methodological limitations, such as the inclusion of mixed interventions, that hindered the evidence synthesis, and the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.

Enrollment: 40 patients

Sex: Male

Ages: 7 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 5 patient groups

G1 (Control group)

Sham Comparator group

Description:

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

Treatment:

Device: ultrasound

G2 expermintal

Experimental group

Description:

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

Treatment:

Device: assigned

G3 expermintal

Experimental group

Description:

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

Treatment:

Drug: Injection, Solution

G4 expermintal

Experimental group

Description:

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

Treatment:

Drug: Injection, Solution

G5 experimental

Experimental group

Description:

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

Treatment:

Device: assigned