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CompletedNCT07738692Updated Jul 31, 2026

Effects of Various Types of Ultrasound Therapy in Knee Osteoarthritis

An interventional study of Metfomin in Knee Arthritis Osteoarthritis, sponsored by Horus University. Completed at 1 site in Egypt. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Horus University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
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Study 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

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Conditions studied

  • Knee Arthritis Osteoarthritis

Keywords

  • knee
  • OA
  • US
  • METFORMIN
  • GLUCOSAMINE
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In context

Lead sponsor

Horus University is the lead sponsor of 31 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    METFORMIN PLUS EXERCISES

    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

  • Active comparator
    GLUCOSAMINE GEL PLUS EXERCISES

    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

  • Placebo comparator
    US PLUS EXERCISES

    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

  • DrugMetfomin

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and after 12 weeks of intervention

  2. 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.

    Time frame: Baseline and after 12 weeks of intervention

  3. 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.

    Time frame: Baseline and after 12 weeks of intervention

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Study locations

1 site
  • Horus University
    Quweisna, Monufia Governorate 16916, Egypt
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References and documents

Related links

Study documents

  • Protocol, analysis plan and consent form · May 3, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07738692
Lead sponsor
Horus University
Responsible party
Ehab A. Abdallah (Associate Professor of Orthopedic Physical Therapy, Horus University) — Principal investigator
First posted
Jul 31, 2026
Start date
Jan 1, 2026
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026
Last update
Jul 31, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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