Status:
RECRUITING
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
Lead Sponsor:
Cairo University
Conditions:
Knee Osteoarthritis
Chitosan Nanoparticles Gel
Eligibility:
All Genders
40-60 years
Phase:
NA
Brief Summary
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 th...
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 degen...
Eligibility Criteria
Inclusion
- Age between ≥40 and ≤ 65 years old.
- Both genders.
- Patients should have OA of the knee, Kellgren-Lawrence scores of 2 and 3 on radiologic evaluation.
- If both knees diagnosed as OA, the most affected one will be selected.
- Diagnosis of KOA who had knee pain and functional disabilities for at least three months, according to American College of Rheumatology classification (ACR) at screening visit.
- Visual Analogue Scale (VAS) at rest score of ≥40 mm.
- Subjects have sufficient cognition that enables them to understand the requirements of the study, comply with the study procedures and visit schedule.
Exclusion
- Patients with any previous knee surgeries or lower limb fractures.
- Chronic inflammatory diseases such as rheumatoid arthritis.
- Any neurological disorders.
- Moderate to significant knee synovitis.
- Hot or red knee.
- History and/or physical examination findings compatible with the internal derangement of knee.
- Pregnancy.
- Patients with BMI more than 35 (morbid obesity).
- Absence of current physical therapy treatments for KOA.
- Cognitive limitations or endocrine disease.
- Patients who had undergone arthroscopy or treatment with intra-articular hyaluronic acid during previous 6 months.
- Use of NSAIDs one week prior to screening visit.
- Orthopedic diseases that may affect or interfere with the therapeutic effect.
- Habitual use of psychotropic or narcotic analgesics for ≥1 week within 8 weeks prior to screening.
- Participated in other intervention studies on the past 6 months to screening
- Participants with congenital musculoskeletal deformity.
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06567301
Start Date
October 25 2023
End Date
June 30 2025
Last Update
August 26 2024
Active Locations (2)
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1
Physical Therapy College - Cairo University
Giza, El Dokki, Egypt, 12613
2
Physical therapy college - Cairo University
Giza, EL Doqqi, Egypt, 12613