Effects of Various Types of Ultrasound Therapy in Knee Osteoarthritis

NCT07738692 | Completed DMC

• 1 other identifier: P.T.REC/012/002810
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Arthritis Osteoarthritis

Keywords

knee; OA; US; METFORMIN; GLUCOSAMINE

Outcome Measures

Primary Outcomes (3)

• 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

  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

  Baseline and after 12 weeks of intervention

• The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  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.

  Baseline and after 12 weeks of intervention

• Change in Knee Joint Range of Motion (ROM)

  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.

  Baseline and after 12 weeks of intervention

Study Arms (3)

METFORMIN PLUS EXERCISES

EXPERIMENTAL

Participants in this arm received phonophoresis treatment using a 1% metformin gel as the ultrasound coupling medium. The treatment was administered according to the study protocol over the intervention period.

Drug: Metfomin

GLUCOSAMINE GEL PLUS EXERCISES

ACTIVE COMPARATOR

Group A (Glucosamine Sulfate, Chondroitin Sulfate, MSM (Methylsulfonylmethane) plus EX group) -Glucosamine sulfate 30mg/g, Chondroitin sulfate 50mg/g and MSM 10mg/g

Drug: Metfomin

US PLUS EXERCISES

PLACEBO COMPARATOR

In the US group (Group C), the US applied using an acoustic neutral gel. The device's parameters and applica¬tion were like those of the MFPH group. Metformin phonophoresis and traditional exercise

Drug: Metfomin

Interventions

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.

GLUCOSAMINE GEL PLUS EXERCISES; METFORMIN PLUS EXERCISES; US PLUS EXERCISES

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Horus University

Quweisna, Monufia Governorate, 16916, Egypt

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedic Physical Therapy

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: July 31, 2026
• Study Start: January 1, 2026
• Primary Completion: April 30, 2026
• Study Completion: June 30, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

EG (1)