Effect of Metformin Iontophoresis on Knee Osteoarthritis in Postmenopausal Women (NCT07395895) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Effect of Metformin Iontophoresis on Knee Osteoarthritis in Postmenopausal Women
Egypt68 participantsStarted 2026-03-01
Plain-language summary
This study is designed as a randomized, double-blind, placebo-controlled clinical trial with two parallel groups. All participants will receive a standardized physical therapy rehabilitation program. Participants will be randomly allocated into either a study group receiving metformin iontophoresis or a control group receiving placebo iontophoresis. Both participants and outcome assessors will be blinded to group allocation.
Who can participate
Age range
50 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Postmenopausal women aged 50-70 years.
* Clinical and radiographic diagnosis of knee osteoarthritis according to the American College of Rheumatology criteria.
* Radiographic severity classified as Kellgren-Lawrence grade II or III.
* Chronic knee pain for a duration of at least 3 months.
* Pain intensity ≥4 on the Visual Analog Scale.
* Ability to ambulate independently with or without assistive devices.
* Ability to understand and follow instructions.
* Willingness to participate and provide written informed consent.
Exclusion Criteria:
* • Severe knee osteoarthritis (Kellgren-Lawrence grade IV).
* History of knee surgery or intra-articular injections within the previous 6 months.
* Presence of inflammatory rheumatic diseases such as rheumatoid arthritis or gout.
* Neurological disorders affecting lower limb function.
* Uncontrolled metabolic, cardiovascular, or systemic diseases.
* Current or recent use of metformin or other antidiabetic medications.
* Skin lesions, infections, or hypersensitivity at the iontophoresis site.
* Contraindications to electrotherapy such as pacemakers or implanted electronic devices.
* Body mass index ≥35 kg/m².
* Participation in another clinical trial within the last 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity
Timeframe: at baseline, after 6 weeks and after 12 weeks
2
Functional status
Timeframe: at baseline, after 6 weeks and after 12 weeks