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

NCT06774469 | Unknown FDA Device

• 1 other identifier: cu III F 89 23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of Knee

Keywords

Osteoarthritis-ultrasound-overdose-albino rats-MIA-Articular cartilage

Outcome Measures

Primary Outcomes (4)

• Samples to estimate the knee cartilage thickness (femoral cartilage)

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

  at the begginig of the experiment and at the end

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

  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

  at the begginig of the experiment and at the end

• Cellular changes

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

  at the begginig of the experiment and at the end

• Inflammatory changes

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

  at the begginig of the experiment and at the end

Study Arms (5)

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

Device: ultrasound

G2 expermintal

EXPERIMENTAL

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

Device: assigned

G3 expermintal

EXPERIMENTAL

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

Drug: Injection, Solution

G4 expermintal

EXPERIMENTAL

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

Drug: Injection, Solution

G5 experimental

EXPERIMENTAL

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

Device: assigned

Interventions

assigned DEVICE

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.

G2 expermintal; G5 experimental

Injection, Solution DRUG

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).

Also known as: MIA induction

G3 expermintal; G4 expermintal

ultrasound DEVICE

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

G1 (Control group)

Eligibility Criteria

• Age: 7 Weeks - 8 Weeks
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Injections; Solutions; Ultrasonography

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Pharmaceutical Preparations; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Shereen Shawky Elabd, Assis. prof

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 40 rats
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist specialist

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 14, 2025
• Study Start: February 7, 2024
• Primary Completion: March 9, 2025
• Study Completion: March 9, 2025
• Last Updated: January 14, 2025

Record last verified: 2024-01

Locations

EG (1)