Effect of Metformin Iontophoresis on Knee Osteoarthritis in Postmenopausal Women

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis in Postmenopausal Women
• Intervention / Treatment: Drug: Metformin gel Iontophoresis; Device: Iontophoresis

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ‪Eman swan‬, Ph d; Phone Number: +201090111013; Email: eman.said@buc.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11829
    • Badr University in Cairo
    • Contact: ‪Eman Sawan, PH D; Phone Number: 01090111013; Email: eman.said@buc.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin Iontophoresis	Drug: Metformin gel Iontophoresis; Metformin gel 2% Iontophoresis Combined with Physical Therapy Rehabilitation
Active Comparator: Iontophoresis Combined with Physical Therapy Rehabilitation	Device: Iontophoresis; Iontophoresis with neutral gel Combined with Physical Therapy Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	assessed using the Visual Analog Scale.	at baseline, after 6 weeks and after 12 weeks
Functional status	assessed using the WOMAC index	at baseline, after 6 weeks and after 12 weeks

Collaborators and Investigators

• Sponsor: Badr University

Publications and helpful links

General Publications

• 1. Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis and Cartilage. 2019;27(11):1578-1589. 2. Kolasinski SL, Neogi T, Hochberg MC, et al. 2020 American College of Rheumatology guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Care & Research. 2020;72(2):149-162. 3. Quicke JG, Foster NE, Ogollah RO, et al. Supervised exercise therapy for knee osteoarthritis: A randomized controlled trial. Ann Rheum Dis. 2022;81(3):336-343. 4. Wang Y, Hussain SM, Wluka AE, et al. Effect of exercise therapy on knee osteoarthritis: Systematic review and meta-analysis. Arthritis Res Ther. 2021;23:147. 5. Zhang W, Doherty M, Peat G, et al. EULAR evidence-based recommendations for knee osteoarthritis management. Ann Rheum Dis. 2020;79(6):685-699.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 1, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Postmenopausal Women; Iontophoresis; Physical Therapy Rehabilitation; Metformin gel
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Investigative Techniques; Therapeutics; Drug Administration Routes; Drug Therapy; Electrochemical Techniques; Electrophoresis; Iontophoresis
• Other Study ID Numbers: IRB00014233-66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No