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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

NCT06567301 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-08-26

No results posted yet for this study

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)

Conditions

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

Interventions

COMBINATION_PRODUCT

Ultrasound therapy combined with Chitosan nanoparticles gel

Gymna - Belgian

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Athar Tarek Mohamed Fahmy Azab · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2025-05-30
Completion
2025-06-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06567301 on ClinicalTrials.gov