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Metformin Iontophoresis and Physical Therapy for Knee Osteoarthritis in Postmenopausal Women

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Study Aim

This study aims to evaluate the effectiveness of Metformin Iontophoresis and Physical Therapy in improving functional status and reducing pain intensity in postmenopausal women with knee osteoarthritis.

What is being tested

Metformin gel Iontophoresis

+ Iontophoresis

DrugDevice
Who is being recruted

Arthritis+2

+ Joint Diseases

+ Musculoskeletal Diseases

From 50 to 70 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorBadr University
Study Contact‪Eman swan‬, Ph d
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on postmenopausal women who have been diagnosed with knee osteoarthritis, a condition where the knee joints become painful and stiff. The goal is to evaluate the effectiveness of a treatment that combines a medication called Metformin, applied through a process known as iontophoresis, along with physical therapy rehabilitation. The study is important as it aims to find a potential new approach to manage knee osteoarthritis in postmenopausal women, which could lead to improved quality of life. Participants in this study are randomly assigned to either the treatment group or the control group, with neither the participants nor the outcome assessors knowing who receives which treatment. The treatment group receives Metformin through iontophoresis, a method that uses a mild electrical current to deliver the medication through the skin, along with physical therapy. The control group receives a placebo, or dummy treatment, through iontophoresis and the same physical therapy. The study measures the results by looking at changes in functional status, assessed using the WOMAC index, and pain intensity, assessed using the Visual Analog Scale.

Official TitleEffect of Metformin Iontophoresis Combined With Physical Therapy Rehabilitation on Knee Osteoarthritis in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Clinical Trial
Principal SponsorBadr University
Study Contact‪Eman swan‬, Ph d
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 50 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic Diseases

Criteria

8 inclusion criteria required to participate
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.

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10 exclusion criteria prevent from participating
Body mass index ≥35 kg/m².

Presence of inflammatory rheumatic diseases such as rheumatoid arthritis or gout.

Participation in another clinical trial within the last 3 months.

History of knee surgery or intra-articular injections within the previous 6 months.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Participants in this group receive Metformin gel 2% Iontophoresis combined with Physical Therapy Rehabilitation. This is an active treatment group, not a placebo.

Group II

Active Comparator
Participants in this group receive Iontophoresis with neutral gel along with Physical Therapy Rehabilitation. This is an active treatment group, not a placebo or control group.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Badr University in Cairo

Cairo, EgyptOpen Badr University in Cairo in Google Maps
Recruiting soonOne Study Center
Metformin Iontophoresis and Physical Therapy for Knee Osteoarthritis in Postmenopausal Women | PatLynk