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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
Led by Cairo University · Updated on 2024-08-26
120
Participants Needed
2
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A parallel double blinded randomized controlled clinical trial (RCT) with a 1:1:1 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)
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 65 years old
- Both genders
- Diagnosis of knee osteoarthritis with Kellgren-Lawrence scores of 2 or 3 on radiologic evaluation
- If both knees have osteoarthritis, the most affected knee will be selected
- Knee pain and functional disabilities for at least three months according to American College of Rheumatology criteria
- Visual Analogue Scale (VAS) at rest score of 40 mm or higher
- Sufficient cognition to understand study requirements and comply with procedures and visit schedules
You will not qualify if you...
- Previous knee surgeries or lower limb fractures
- Chronic inflammatory diseases such as rheumatoid arthritis
- Neurological disorders
- Moderate to significant knee synovitis
- Hot or red knee
- Internal derangement of the knee
- Pregnancy
- Body mass index (BMI) over 35
- Current physical therapy treatments for knee osteoarthritis
- Cognitive limitations or endocrine diseases
- Arthroscopy or intra-articular hyaluronic acid treatment within previous 6 months
- Use of NSAIDs within one week prior to screening
- Orthopedic diseases affecting therapeutic effect
- Habitual use of psychotropic or narcotic analgesics for one week or more within 8 weeks prior to screening
- Participation in other intervention studies within 6 months prior to screening
- Congenital musculoskeletal deformities
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Physical Therapy College - Cairo University
Giza, El Dokki, Egypt, 12613
Actively Recruiting
2
Physical therapy college - Cairo University
Giza, EL Doqqi, Egypt, 12613
Actively Recruiting
Research Team
A
Athar Tarek Mohamed Fahmy Azab, Master
CONTACT
H
Hamdy Mamdouh Amir
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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