Effects of Various Types of Ultrasound Therapy in Knee Osteoarthritis

Knee osteoarthritis (KOA) is a degenerative joint condition characterized by degeneration, which is commonly attributed to the cumulative effects of mechanical stress and the slow deterioration of articular cartilage. KOA is a highly prevalent musculoskeletal disorder that affected 300 million people globally in 2017. It can affect any joint, although the most commonly affected are the knees, hands, hips, and spine

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Key information

Conditions

Knee Arthritis Osteoarthritis

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Horus University

Quweisna, Monufia Governorate, 16916, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 45 to 65 years.
Body mass index (BMI) 18.5-29.9 kg/m².
Diagnosis of knee osteoarthritis according to the American College of Rheumatology criteria.
Kellgren-Lawrence grade I-III.

Exclusion criteria

Rheumatologic conditions such as rheumatoid arthritis.
Prior knee surgery.
Previous lower-extremity fracture involving the knee joint.
Diabetes mellitus.
Neuropathy or sensory disorders.
Intra-articular corticosteroid injection or platelet-rich plasma treatment within the previous 6 months.
Thrombosis of the lower limbs.
Contraindications to therapeutic ultrasound, including open epiphysis, infection, cardiac disease, metal implants, pacemaker, pregnancy, or thrombophlebitis.
Wound or laceration in the soft tissues surrounding the knee.
Skin disease around the treatment area.
Use of pain medications during the study that could influence outcomes.
Knee physiotherapy within the previous 3 months.
Other knee procedures, including aspiration or knee arthroplasty.

Treatment and study plan

Metfomin

Drug

The metformin gel (medicinal coupling medium) was prepared with the assistance of Professor Abdel-Hamid M Nabil at the Faculty of Pharmacy, Kafr El-Sheikh Uni¬versity. Metformin gel 1% was prepared as described by Baldassari et al. [27]. [27]. All the required formulation ingredients were weighed accurately. Metformin HCl powder 34.5 g was dissolved in 20 ml glycerin. Then, the prepared solution was added gradually to 2850 g of the ultrasound gel with constant mixing to ensure homo¬geneity. Finally, 2.85 g of sodium citrate was added as a preservative, and the mixing continued until clear gel was obtained (10-15 min). Its color, appearance, and odor were quite like the coupling agent routinely used in the US. Lastly, the prepared gel was sealed in 30 g tubes and subsequently utilized to evaluate the clinical impacts.

Primary outcomes

Change in Knee Pain Intensity (VAS Score) Description: Pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. The

Time frame: Baseline and after 12 weeks of intervention

Pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. The primary outcome is the change in VAS score from baseline to
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Time frame: Baseline and after 12 weeks of intervention

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to evaluate pain, stiffness, and physical function. The total score ranges from 0 to 96, with higher scores indicating worse symptoms. The outcome is the change in total score from baseline to post-treatment.
Change in Knee Joint Range of Motion (ROM)

Time frame: Baseline and after 12 weeks of intervention

Knee flexion and extension range of motion will be measured using a standard universal goniometer. The outcome is the change in degrees of motion from baseline to post-treatment.

Sponsors and collaborators

Lead sponsor

Horus University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 31, 2026
Registry last updated: Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed