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

NCT06774469 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-14

No results posted yet for this study

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.

Conditions

  • Osteoarthritis of Knee

Interventions

DEVICE

assigned

Group II: (Normal-US Group): The rats will receive 2 sessions/ day of underwater pulsed US waves with 1 MHZ frequency and 1 watt/cm2 power, for 10 min for 30 consequent days applied to the right knee. The rats will be sacrificed after 30 days. Group V: (Osteoarthritis-US group) after two weeks of chemical induction of osteoarthritis, the rats will receive 2 sessions/ day of underwater pulsed US waves with 1 MHZ frequency and 1 watt/cm2 power for 10 min for 30 consequent days applied to the right knee. The rats will be sacrificed after 44 days.

DRUG

Injection, Solution

Group III: (Osteoarthritis-induced group): For studying the histological changes of the articular knee joint after osteoarthritis induction in the right knee joint before recovery occur. The patellar ligament will be palpated below the patella and a single intra-articular injection of (MIA lateral to the ligament using an insulin syringe will be performed). The rats will be injected once with monosodium iodoacetate (MIA) dissolved in sterile saline (6 mg/kg body weight, 50 μL). Saline acts as a vehicle for MIA. The rats will be sacrificed after 14 days of MIA injection (1st day of the experiment). Group IV: (Osteoarthritis-Recovery group): The rats will be injected once with monosodium iodoacetate (MIA) dissolved in sterile saline (6 mg/kg body weight, 50 μL), Saline acts as a vehicle for MIA and will not receive any medication. The rats will be sacrificed after 44 days of MIA injection (1st day of the experiment).

DEVICE

ultrasound

Group I:Sham Comparator (Control group): for studying the normal histological structure of the articular knee joint.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Shereen Shawky Elabd, Assis. prof · Tanta University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Weeks
Max Age
8 Weeks
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-07
Primary Completion
2025-03-09
Completion
2025-03-09
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06774469 on ClinicalTrials.gov