Extracorporeal Shockwave Versus Phonophoresis on Functional and Anatomical Changes Detected With Artificial Intelligence Technology in Knee Osteoarthritis
Trial ID: NCT06567301
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-10-25
Completion date: 2025-06-30
Sponsor: Cairo University
Conditions: Knee Osteoarthritis; Chitosan Nanoparticles Gel; Artificial Intelligence Texture Analysis Bases Algorithm; Subchondral Bone Changes (Anatomical Changes); Extracorporeal Shockwave
Interventions: Ultrasound therapy combined with Chitosan nanoparticles gel
Locations: Physical Therapy College - Cairo University; Physical therapy college - Cairo University
Countries: Egypt; Egypt
Enrollment: 120
Age range: 40 Years - 60 Years
Sex: ALL

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 criteria:
Inclusion Criteria:

1. Age between ≥40 and ≤ 65 years old.
2. Both genders.
3. Patients should have OA of the knee, Kellgren-Lawrence scores of 2 and 3 on radiologic evaluation.
4. If both knees diagnosed as OA, the most affected one will be selected.
5. 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.
6. Visual Analogue Scale (VAS) at rest score of ≥40 mm.
7. Subjects have sufficient cognition that enables them to understand the requirements of the study, comply with the study procedures and visit schedule.

Exclusion Criteria:

1. Patients with any previous knee surgeries or lower limb fractures.
2. Chronic inflammatory diseases such as rheumatoid arthritis.
3. Any neurological disorders.
4. Moderate to significant knee synovitis.
5. Hot or red knee.
6. History and/or physical examination findings compatible with the internal derangement of knee.
7. Pregnancy.
8. Patients with BMI more than 35 (morbid obesity).
9. Absence of current physical therapy treatments for KOA.
10. Cognitive limitations or endocrine disease.
11. Patients who had undergone arthroscopy or treatment with intra-articular hyaluronic acid during previous 6 months.
12. Use of NSAIDs one week prior to screening visit.
13. Orthopedic diseases that may affect or interfere with the therapeutic effect.
14. Habitual use of psychotropic or narcotic analgesics for ≥1 week within 8 weeks prior to screening.
15. Participated in other intervention studies on the past 6 months to screening
16. Participants with congenital musculoskeletal deformity.

Outcomes:
Anatomical improvement