Osteoarthritis of KneeNCT06774469
Effect of Overdose Ultrasound on Osteoarthritic Knee in Adult Albino Rat: a Histological Study
A study testing assigned, Injection, Solution and ultrasound in people with Osteoarthritis of Knee, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 8 weeks, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- assigned, Injection, Solution and ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Feb 2024to 9 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 8 weeks
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Weight < 200-250 > kg.
- Rats with injured thighs and/or knees.
- Female rats.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Overdose Ultrasound on the Articular Cartilage of the Osteoarthritic Knee in Adult Albino Rat: a Histological Study
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.
Read the 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.
- Conditions
- Osteoarthritis of Knee
- Being tested
- assigned, Injection, Solution, ultrasound
- Keywords
- Osteoarthritis-ultrasound-overdose-albino rats-MIA-Articular cartilage
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assignedDevice
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.
Injection, SolutionDrug
Also called MIA induction
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).
ultrasoundDevice
Group I:Sham Comparator (Control group): for studying the normal histological structure of the articular knee joint.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: ultrasound |
| G2 expermintal | Experimental | (Normal-US Group) Will be assessed after 30 consequent days Receives: Device: assigned |
| G3 expermintal | Experimental | (Osteoarthritis-induced group)Will be assessed after 14 days Receives: Drug: Injection, Solution |
| G4 expermintal | Experimental | (Osteoarthritis-Recovery group): Will be assessed after44 days Receives: Drug: Injection, Solution |
| G5 experimental | Experimental | (Osteoarthritis-US group) Will be assessed after 44 days Receives: Device: assigned |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 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
Measured: 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.
Measured: 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).
Measured: at the begginig of the experiment and at the end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start7 Feb 2024
- Primary completion9 Mar 2025 (estimated)
- Study completion9 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahenda Mohamed Eissa, Cairo University
- Investigators
- Shereen Shawky Elabd, Assis. prof, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774469
- Sponsor's protocol ID
- cu III F 89 23
- Status last verified
- Jan 2024
- First submitted
- 24 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Overdose Ultrasound on the Articular Cartilage of the Osteoarthritic Knee in Adult Albino Rat: a Histological Study
- ClinicalTrials.gov ID
- NCT06774469
- Acronym / sponsor ID
- cu III F 89 23
- Conditions
- Osteoarthritis of Knee
- Keywords
- Osteoarthritis-ultrasound-overdose-albino rats-MIA-Articular cartilage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 9 Mar 2025 (estimated)
- Study completion
- 9 Mar 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| G1 (Control group) | Sham comparator | Device: ultrasound(Normal group) For studying the normal histological structure of the articular knee joint. Will be assessed at the beginning of the study |
| G2 expermintal | Experimental | Device: assigned(Normal-US Group) Will be assessed after 30 consequent days |
| G3 expermintal | Experimental | Drug: Injection, Solution(Osteoarthritis-induced group)Will be assessed after 14 days |
| G4 expermintal | Experimental | Drug: Injection, Solution(Osteoarthritis-Recovery group): Will be assessed after44 days |
| G5 experimental | Experimental | Device: assigned(Osteoarthritis-US group) Will be assessed after 44 days |
Who may qualify
- Ages
- 7 to 8 weeks
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Weight < 200-250 > kg.
- Rats with injured thighs and/or knees.
- Female rats.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assignedGroup 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. | Device | G2 expermintal, G5 experimental |
| Injection, SolutionAlso: MIA inductionGroup 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). | Drug | G3 expermintal, G4 expermintal |
| ultrasoundGroup I:Sham Comparator (Control group): for studying the normal histological structure of the articular knee joint. | Device | G1 (Control group) |
Primary outcome
Samples to estimate the knee cartilage thickness (femoral cartilage)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shereen Shawky Elabd, Assis. prof study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assigned, Injection, Solution and ultrasound in people with Osteoarthritis of Knee, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Samples to estimate the knee cartilage thickness (femoral cartilage) (time frame: at the begginig of the experiment and at the end). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.