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Compares treatment options for Knee Osteoarthritis
Official title 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
ClinicalTrials.gov ID: NCT06567301
What this study is testing
What is Ultrasound therapy combined with Chitosan nanoparticles gel?
Ultrasound therapy combined with Chitosan nanoparticles gel is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for knee osteoarthritis.
Also referred to as Extracorporeal Shockwave Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 60
You may be able to join 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...
You likely can't join 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.
See the full eligibility criteria
- 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.
- people have sufficient cognition that enables them to understand the requirements of the study, comply with the study procedures and visit schedule.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Giza, El Dokki, Egypt
- Giza, EL Doqqi, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Giza, El Dokki, Egypt; Giza, EL Doqqi, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.