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NCT Number: NCT07395895

Effect of Metformin Iontophoresis on Knee Osteoarthritis in Postmenopausal Women

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.

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Key information

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

About this study

The study population will consist of postmenopausal women diagnosed with knee osteoarthritis. Postmenopause is defined as the absence of menstruation for at least 12 consecutive months. Participants will be randomly assigned to either the study or control group using a computer-generated randomization sequence. Allocation concealment will be ensured using sealed opaque envelopes. Both participants and outcome assessors will be blinded to the treatment allocation. The physical therapist applying iontophoresis will not be involved in outcome assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metformin gel Iontophoresis

Drug

Metformin gel 2% Iontophoresis Combined with Physical Therapy Rehabilitation

Iontophoresis

Device

Iontophoresis with neutral gel Combined with Physical Therapy Rehabilitation

Primary outcomes

  1. Pain intensity

    Time frame: at baseline, after 6 weeks and after 12 weeks

    assessed using the Visual Analog Scale.

  2. Functional status

    Time frame: at baseline, after 6 weeks and after 12 weeks

    assessed using the WOMAC index

Study contacts

Contact information is provided by the study sponsor or research team.

‪Eman swan‬, Ph d

CONTACT

[email protected]

+201090111013

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Official study title

Effect of Metformin Iontophoresis Combined With Physical Therapy Rehabilitation on Knee Osteoarthritis in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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