RecruitingNot ApplicableNCT06567301

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

Extracorporeal Shockwave Versus Phonophoresis on Functional and Anatomical Changes Detected With Artificial Intelligence Technology in Knee Osteoarthritis


Sponsor

Cairo University

Enrollment

120 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

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 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)


Eligibility

Min Age: 40 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This randomized controlled trial is comparing three treatments for knee osteoarthritis: phonophoresis (ultrasound therapy) using a chitosan nanoparticle gel, extracorporeal shockwave therapy (ECSWT), and traditional exercises to assess which best reduces pain, improves function, and favorably changes the bone structure beneath the knee joint cartilage (subchondral bone). The study also uses an AI-based image analysis tool to detect subtle changes in bone texture that conventional X-ray grading may miss. Adults aged 40 to 65 with knee osteoarthritis graded 2 or 3 on the Kellgren-Lawrence scale, knee pain for at least 3 months, and pain of at least 40mm on a visual scale are eligible; those with prior knee surgery, rheumatoid arthritis, neurological disorders, or pregnancy are excluded. Participants will be assigned to one of three groups and receive 12 (phonophoresis/exercise) or 5 (shockwave) sessions over 4 weeks, with assessments before and after treatment. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTUltrasound therapy combined with Chitosan nanoparticles gel

Gymna - Belgian


Locations(2)

Physical Therapy College - Cairo University

Giza, El Dokki, Egypt

Physical therapy college - Cairo University

Giza, EL Doqqi, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06567301


Related Trials