Knee Arthritis OsteoarthritisNCT07738692
Effects of Various Types of Ultrasound Therapy in Knee Osteoarthritis
A study testing Metfomin in people with Knee Arthritis Osteoarthritis, run by Horus University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Arthritis Osteoarthritis
- What is being tested?
- Metfomin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Metfomin
- Keywords
- knee, OA, US, METFORMIN, GLUCOSAMINE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetfominDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Drug: Metfomin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Baseline and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Jan 2026
- Primary completion30 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab A. Abdallah, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738692
- Sponsor's protocol ID
- P.T.REC/012/002810
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Various Types of Ultrasound Therapy in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07738692
- Acronym / sponsor ID
- P.T.REC/012/002810
- Conditions
- Knee Arthritis Osteoarthritis
- Keywords
- knee, OA, US, METFORMIN, GLUCOSAMINE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| METFORMIN PLUS EXERCISES | Experimental | Drug: MetfominParticipants 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. |
| GLUCOSAMINE GEL PLUS EXERCISES | Active comparator | Drug: MetfominGroup A (Glucosamine Sulfate, Chondroitin Sulfate, MSM (Methylsulfonylmethane) plus EX group) -Glucosamine sulfate 30mg/g, Chondroitin sulfate 50mg/g and MSM 10mg/g |
| US PLUS EXERCISES | Placebo comparator | Drug: MetfominIn 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 |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Rheumatologic conditions such as rheumatoid arthritis.
- Prior knee surgery.
- Previous lower-extremity fracture involving the knee joint.
- Diabetes mellitus.
- Neuropathy or sensory disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetfominThe 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. | Drug | GLUCOSAMINE GEL PLUS EXERCISES, METFORMIN PLUS EXERCISES, US PLUS EXERCISES |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metfomin in people with Knee Arthritis Osteoarthritis, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.