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
Recruiting now · Not applicable
Conditions studied: Knee Osteoarthritis, Chitosan Nanoparticles Gel, Artificial Intelligence Texture Analysis Bases Algorithm, Subchondral Bone Changes (Anatomical Changes), Extracorporeal Shockwave
In brief
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)
Key facts
- Study ID
- NCT06567301
- Run by
- Cairo University
- People needed
- 120
- Starts
- 2023-10-25
- Expected to finish
- 2025-06-30
- Last updated by the study team
- 2024-08-26
Who can join
Age: 40 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between ≥40 and ≤ 65 years old.
- Both genders.
- Patients should have OA of the knee, Kellgren-Lawrence scores of 2 and 3 on radiologic evaluation.
- If both knees diagnosed as OA, the most affected one will be selected.
- 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.
- Visual Analogue Scale (VAS) at rest score of ≥40 mm.
- Subjects have sufficient cognition that enables them to understand the requirements of the study, comply with the study procedures and visit schedule.
You may not qualify if…
- Patients with any previous knee surgeries or lower limb fractures.
- Chronic inflammatory diseases such as rheumatoid arthritis.
- Any neurological disorders.
- Moderate to significant knee synovitis.
- Hot or red knee.
- History and/or physical examination findings compatible with the internal derangement of knee.
- Pregnancy.
- Patients with BMI more than 35 (morbid obesity).
- Absence of current physical therapy treatments for KOA.
- Cognitive limitations or endocrine disease.
- Patients who had undergone arthroscopy or treatment with intra-articular hyaluronic acid during previous 6 months.
- Use of NSAIDs one week prior to screening visit.
- Orthopedic diseases that may affect or interfere with the therapeutic effect.
- Habitual use of psychotropic or narcotic analgesics for ≥1 week within 8 weeks prior to screening.
- Participated in other intervention studies on the past 6 months to screening
- Participants with congenital musculoskeletal deformity.
Where it is running
- Physical Therapy College - Cairo University — Giza, El Dokki, Egypt (enrolling)
- Physical therapy college - Cairo University — Giza, EL Doqqi, Egypt (enrolling)
Full record on ClinicalTrials.gov
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