Effect of Metformin Iontophoresis on Knee Osteoarthritis in Postmenopausal Women

NCT07395895 · tracked via the Priya Life Science Egypt tracker

Sponsor

Badr University

Phase

Phase 3

Started

2026-03-01

Last updated

2026-02-09

Condition(s) studied

Osteoarthritis in Postmenopausal Women

Investigational drug(s) / intervention(s)

Metformin gel IontophoresisIontophoresis

Metformin gel Iontophoresis: Metformin gel 2% Iontophoresis Combined with Physical Therapy Rehabilitation

Iontophoresis: Iontophoresis with neutral gel Combined with Physical Therapy Rehabilitation

Study 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.

Eligibility

Sex

FEMALE

Min age

50 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

Pain intensity — at baseline, after 6 weeks and after 12 weeks
assessed using the Visual Analog Scale.
Functional status — at baseline, after 6 weeks and after 12 weeks
assessed using the WOMAC index

Trial sites (1)

Facility	City	Region	Status
Badr University in Cairo	Cairo	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07395895 on ClinicalTrials.gov ↗ ← All trials in Egypt