Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567301
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Extracorporeal Shockwave Versus Phonophoresis Using Chitosan-Nanoparticles Gel on Functional and Anatomical Changes Detected With Artificial Intelligence Based Texture Analysis Algorithm in Knee Osteoarthritis Patients A Double Blind Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Extracorporeal Shockwave Versus Phonophoresis on Functional and Anatomical Changes Detected With Artificial Intelligence Technology in Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A parallel double blinded randomized controlled clinical trial RCT with a 111 allocation will be conducted in an orthopedic clinic in Cairo and Giza Governments - Egypt
This RCT will evaluate the pain reduction self-reported functional improvement physical functional and anatomical improvement following the application of phonophoresis using chitosan-nanoparticles gel ECSW therapy and traditional exercises compared to each other
The treatment period will last for 4 weeks with a total of 12 sessions 3 sessions per week for the application of phonophoresis using chitosan-nanoparticles gel and traditional exercises program and 5 sessions 1 every week for the application of ECSWT The participants will be assessed at two different time-points before-after treatment with a sample size of 40 patients in each group 3 groups
This RCT will evaluate the pain reduction self-reported functional improvement physical functional and anatomical improvement following the application of phonophoresis using chitosan-nanoparticles gel ECSW therapy and traditional exercises compared to each other
The treatment period will last for 4 weeks with a total of 12 sessions 3 sessions per week for the application of phonophoresis using chitosan-nanoparticles gel and traditional exercises program and 5 sessions 1 every week for the application of ECSWT The participants will be assessed at two different time-points before-after treatment with a sample size of 40 patients in each group 3 groups
Detailed Description:
Osteoarthritis OA is a common degenerative disease that is ranked as the 10th largest contributor to disabilities that has a link to higher comorbidity and excess mortality One of most common degenerative diseases is knee osteoarthritis KOA KOA is a progressive chronic degenerative condition that places a heavy socioeconomic burden on healthcare systems and society The prevalence of knee OA has sharply increased to more than the double in the last 10 years as result of steady state in life expectancy
KOA is a well-known as a cartilage disease that involves degradation and loss of articular cartilage However OA is usually accompanied by changes in the subchondral bone with sclerosis bone cyst and osteophyte formation
Recent studies reported that subchondral bone remodeling plays a very important role in KOA mediating and preceding cartilage damage The increase in subchondral bone stiffness decreases the ability to scatter the loading forces within the knee joint which then increases the force loaded on articular cartilage Therefore the cartilage damage and progress of OA accelerated over time The focus of treatment in early KOA have shifted from the articular cartilage to the subchondral bone and become a potential therapeutic target of various therapeutic methods
Regarding KOA pain accumulating evidence suggests that bottom-up vascularization from subchondral bone plays a larger role than top-down vessel invasion originating from synovial tissue or synovium during cartilage erosion in OA As a result it is a common complaint of orthopedists that osteoarthritis pain is not associated with the radiographic presentation Recent work revealed a relatively weak relationship between cartilage loss and OA joint pain
As different approaches aimed at articular cartilage or synovial components had inefficient results and the mechanism of bone cartilage crosstalk is gradually becoming clear this study will try to confirm the critical role of subchondral bone in knee osteoarthritis and that subchondral bone could be an ideal outcome measure of osteoarthritis treatment
Low-intensity pulsed ultrasound LIPUS and extracorporeal shockwave therapy ECSWT are effective as a non-invasive method in histopathological recovery with more intense sight ECSWT has shown effectiveness in the regression of early KOA associated with improving the subchondral bone remodeling decrease the number of osteophytes and it can also increase osteocytes activity Besides ECSWT could alleviate chronic inflammatory activities in the whole joint through down-regulating inflammatory cytokines Additionally it was reported that application of ESWT to the subchondral bone of the knee significantly increased bone volume and trabecular number and reduced bone porosity Overall ESWT could reverse the pathology of OA progression to some extent
Low-intensity US might influence the subchondral bone unit under joint disuse LIUS with its associated acoustic radiation force can alleviate subchondral bone sclerosis during OA progression under normal joint use In addition if US technology combined with bioactive compounds materials as chitosan CS could improve the encapsulation efficiency of bioactive compounds whereas not only reduced the nanoparticle size but also narrowed their size distribution this makes US as an effective delivery of biomaterials such as chitosan In this context inclusion of mixed interventions with US could improve its effect Therefore this study will couple the use of US therapy with a new green environmentally friendly material called chitosan in the form of a topical gel
Chitosan appears as proteoglycan in the extracellular matrix shells of some species of cephalopods Chitosans biocompatibility gradual degradability non-toxicity biological activity anti-inflammatory properties and antibacterial action makes chitosan regarded as the best material for hydrogel Some studies used CS as intra-articular injection for KOA and concluded that CS can promote chondrocyte proliferation block inflammatory and catabolic mediators Therefore Phonophoresis using chitosan could reduce inflammation limit cartilage degeneration and improve subchondral bone remodeling process
Additionally it is well known that confirming diagnosis of KOA is based on assessing joint space width and this is carried out through radiography which depends on the Kellgren-Lawrence grade K-LG scale Despite K-LG scale is considered the most used classical diagnostic tool for KO it has several drawbacks including its application to the progression of diseases its insensitivity to change or inconsistencies in the authors initial descriptions Furthermore it is limited in how it evaluates treatment efficacy because it mostly uses pain scores
By looking to the adverse effects of conventional radiology many studies had reported the possibility of an allergic reaction expensive costs lengthy inspection times and difficulties in scanning patients with specific conditions
Taking this into account artificial intelligence AI-based approaches are starting to be used to solve these issues as image identification pre-operative risk assessment clinical decision- making and analysis of large data sets diagnosis monitor prognosis of rheumatological diseases identifying risk factors for complications and has the unique ability to anticipate outcomes using patient-specific algorithms AI plays a vital role in the appraisal of treatment in which key progress in the clinical practice of rheumatology is the innovation of advanced imaging modalities
The use of AI in orthopedics has mostly concentrated on the development of Machine learning ML and deep learning DL on these pictures Deep learning which is a subset of ML can assist in automatic interpretation of medical images which may increase diagnostic accuracy and speed flag the most urgent and critical patients for immediate attention reduce the amount of human error caused by fatigue andor inexperience lessen the strain on medical professionals by reducing their workload and in general improve orthopedic care
Subchondral bone-remodeling process was reported previously as an important pathophysiology of KO whereas subchondral bone sclerosis is widely considered to be the hallmark of OA Texture analysis TA algorithm is used to detect changes in the subchondral bone density during remodeling process It was demonstrated encouraging findings and the potential of automated texture analysis employing an AI algorithm as a diagnostic tool for OA in comparison to traditional TA techniques Bone structure value BSV is considered as a maximum-likelihood estimator of OA as automated TA depends on it in the analysis and assessment process that measures the micro-structure of the tibial subchondral bone depends on area of interest ROI Consequently the purpose of this study is to explore the difference between ECSWT LIUS and traditional exercises regarding the pain reduction functional improvement self-reported and physical function and anatomical improvement of subchondral bone trabecular tibial bone micro-structural changes
KOA is a well-known as a cartilage disease that involves degradation and loss of articular cartilage However OA is usually accompanied by changes in the subchondral bone with sclerosis bone cyst and osteophyte formation
Recent studies reported that subchondral bone remodeling plays a very important role in KOA mediating and preceding cartilage damage The increase in subchondral bone stiffness decreases the ability to scatter the loading forces within the knee joint which then increases the force loaded on articular cartilage Therefore the cartilage damage and progress of OA accelerated over time The focus of treatment in early KOA have shifted from the articular cartilage to the subchondral bone and become a potential therapeutic target of various therapeutic methods
Regarding KOA pain accumulating evidence suggests that bottom-up vascularization from subchondral bone plays a larger role than top-down vessel invasion originating from synovial tissue or synovium during cartilage erosion in OA As a result it is a common complaint of orthopedists that osteoarthritis pain is not associated with the radiographic presentation Recent work revealed a relatively weak relationship between cartilage loss and OA joint pain
As different approaches aimed at articular cartilage or synovial components had inefficient results and the mechanism of bone cartilage crosstalk is gradually becoming clear this study will try to confirm the critical role of subchondral bone in knee osteoarthritis and that subchondral bone could be an ideal outcome measure of osteoarthritis treatment
Low-intensity pulsed ultrasound LIPUS and extracorporeal shockwave therapy ECSWT are effective as a non-invasive method in histopathological recovery with more intense sight ECSWT has shown effectiveness in the regression of early KOA associated with improving the subchondral bone remodeling decrease the number of osteophytes and it can also increase osteocytes activity Besides ECSWT could alleviate chronic inflammatory activities in the whole joint through down-regulating inflammatory cytokines Additionally it was reported that application of ESWT to the subchondral bone of the knee significantly increased bone volume and trabecular number and reduced bone porosity Overall ESWT could reverse the pathology of OA progression to some extent
Low-intensity US might influence the subchondral bone unit under joint disuse LIUS with its associated acoustic radiation force can alleviate subchondral bone sclerosis during OA progression under normal joint use In addition if US technology combined with bioactive compounds materials as chitosan CS could improve the encapsulation efficiency of bioactive compounds whereas not only reduced the nanoparticle size but also narrowed their size distribution this makes US as an effective delivery of biomaterials such as chitosan In this context inclusion of mixed interventions with US could improve its effect Therefore this study will couple the use of US therapy with a new green environmentally friendly material called chitosan in the form of a topical gel
Chitosan appears as proteoglycan in the extracellular matrix shells of some species of cephalopods Chitosans biocompatibility gradual degradability non-toxicity biological activity anti-inflammatory properties and antibacterial action makes chitosan regarded as the best material for hydrogel Some studies used CS as intra-articular injection for KOA and concluded that CS can promote chondrocyte proliferation block inflammatory and catabolic mediators Therefore Phonophoresis using chitosan could reduce inflammation limit cartilage degeneration and improve subchondral bone remodeling process
Additionally it is well known that confirming diagnosis of KOA is based on assessing joint space width and this is carried out through radiography which depends on the Kellgren-Lawrence grade K-LG scale Despite K-LG scale is considered the most used classical diagnostic tool for KO it has several drawbacks including its application to the progression of diseases its insensitivity to change or inconsistencies in the authors initial descriptions Furthermore it is limited in how it evaluates treatment efficacy because it mostly uses pain scores
By looking to the adverse effects of conventional radiology many studies had reported the possibility of an allergic reaction expensive costs lengthy inspection times and difficulties in scanning patients with specific conditions
Taking this into account artificial intelligence AI-based approaches are starting to be used to solve these issues as image identification pre-operative risk assessment clinical decision- making and analysis of large data sets diagnosis monitor prognosis of rheumatological diseases identifying risk factors for complications and has the unique ability to anticipate outcomes using patient-specific algorithms AI plays a vital role in the appraisal of treatment in which key progress in the clinical practice of rheumatology is the innovation of advanced imaging modalities
The use of AI in orthopedics has mostly concentrated on the development of Machine learning ML and deep learning DL on these pictures Deep learning which is a subset of ML can assist in automatic interpretation of medical images which may increase diagnostic accuracy and speed flag the most urgent and critical patients for immediate attention reduce the amount of human error caused by fatigue andor inexperience lessen the strain on medical professionals by reducing their workload and in general improve orthopedic care
Subchondral bone-remodeling process was reported previously as an important pathophysiology of KO whereas subchondral bone sclerosis is widely considered to be the hallmark of OA Texture analysis TA algorithm is used to detect changes in the subchondral bone density during remodeling process It was demonstrated encouraging findings and the potential of automated texture analysis employing an AI algorithm as a diagnostic tool for OA in comparison to traditional TA techniques Bone structure value BSV is considered as a maximum-likelihood estimator of OA as automated TA depends on it in the analysis and assessment process that measures the micro-structure of the tibial subchondral bone depends on area of interest ROI Consequently the purpose of this study is to explore the difference between ECSWT LIUS and traditional exercises regarding the pain reduction functional improvement self-reported and physical function and anatomical improvement of subchondral bone trabecular tibial bone micro-structural changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None