Comparing shockwave therapy and phonophoresis with chitosan gel for knee osteoarthritis

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

This study is testing whether shockwave therapy or a special gel treatment can help people with knee osteoarthritis feel less pain and move better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 40 Years to 60 Years
• Sex: All
• Sponsor: Cairo University (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Giza, El Dokki and 1 other locations)
• Trial ID: NCT06567301 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of two treatment methods, extracorporeal shockwave therapy (ECSW) and phonophoresis using chitosan-nanoparticles gel, in patients with knee osteoarthritis. It is a double-blind randomized controlled trial involving 120 participants divided into three groups, each receiving a different treatment over a four-week period. The study aims to assess pain reduction, functional improvement, and anatomical changes using advanced artificial intelligence-based texture analysis. Participants will be evaluated before and after treatment to determine the outcomes of each intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 40 to 65 with knee osteoarthritis and moderate pain.

Not a fit: Patients with previous knee surgeries, chronic inflammatory diseases, or significant knee synovitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new, effective treatment options for patients suffering from knee osteoarthritis.

How similar studies have performed: While there have been studies on similar treatments, this specific combination of therapies and the use of AI for analysis is relatively novel.

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.

Where this trial is running

Giza, El Dokki and 1 other locations

• Physical Therapy College - Cairo University — Giza, El Dokki, Egypt (Recruiting)
• Physical therapy college - Cairo University — Giza, EL Doqqi, Egypt (Recruiting)

Study contacts

• Principal investigator: Athar Tarek Mohamed Fahmy Azab — Cairo University
• Study coordinator: Athar Tarek Mohamed Fahmy Azab, Master

Conditions Knee Osteoarthritis; Chitosan Nanoparticles Gel; Artificial Intelligence Texture Analysis Bases Algorithm; Subchondral Bone Changes; Extracorporeal Shockwave; knee osteoarthritis; chitosan nanoparticles gel; artificial intelligence