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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis; Chitosan Nanoparticles Gel; Artificial Intelligence Texture Analysis Bases Algorithm; Subchondral Bone Changes (Anatomical Changes); Extracorporeal Shockwave

• Registration Number: NCT06567301
• Lead Sponsor: Cairo University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age between =40 and = 65 years old.<br><br> 2. Both genders.<br><br> 3. Patients should have OA of the knee, Kellgren-Lawrence scores of 2 and 3 on<br> radiologic evaluation.<br><br> 4. If both knees diagnosed as OA, the most affected one will be selected.<br><br> 5. Diagnosis of KOA who had knee pain and functional disabilities for at least three<br> months, according to American College of Rheumatology classification (ACR) at<br> screening visit.<br><br> 6. Visual Analogue Scale (VAS) at rest score of =40 mm.<br><br> 7. Subjects have sufficient cognition that enables them to understand the requirements<br> of the study, comply with the study procedures and visit schedule.<br><br>Exclusion Criteria:<br><br> 1. Patients with any previous knee surgeries or lower limb fractures.<br><br> 2. Chronic inflammatory diseases such as rheumatoid arthritis.<br><br> 3. Any neurological disorders.<br><br> 4. Moderate to significant knee synovitis.<br><br> 5. Hot or red knee.<br><br> 6. History and/or physical examination findings compatible with the internal<br> derangement of knee.<br><br> 7. Pregnancy.<br><br> 8. Patients with BMI more than 35 (morbid obesity).<br><br> 9. Absence of current physical therapy treatments for KOA.<br><br> 10. Cognitive limitations or endocrine disease.<br><br> 11. Patients who had undergone arthroscopy or treatment with intra-articular hyaluronic<br> acid during previous 6 months.<br><br> 12. Use of NSAIDs one week prior to screening visit.<br><br> 13. Orthopedic diseases that may affect or interfere with the therapeutic effect.<br><br> 14. Habitual use of psychotropic or narcotic analgesics for =1 week within 8 weeks prior<br> to screening.<br><br> 15. Participated in other intervention studies on the past 6 months to screening<br><br> 16. Participants with congenital musculoskeletal deformity.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anatomical improvement

Secondary Outcome Measures

Name	Time	Method
level of knee pain