Effect of Metformin Iontophoresis on Knee Osteoarthritis in Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin gel Iontophoresis, Iontophoresis.
- Who it may be relevant to
- Registry conditions: Osteoarthritis in Postmenopausal Women. Basic parameters: 50 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Metformin Iontophoresis Combined With Physical Therapy Rehabilitation on Knee Osteoarthritis in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Clinical Trial
Overview
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.
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.
Interventions
- Drug Metformin gel Iontophoresis
Metformin gel 2% Iontophoresis Combined with Physical Therapy Rehabilitation - Device Iontophoresis
Iontophoresis with neutral gel Combined with Physical Therapy Rehabilitation
Primary outcome measures
- Pain intensity [Time frame: at baseline, after 6 weeks and after 12 weeks]
- Functional status [Time frame: at baseline, after 6 weeks and after 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Badr University in Cairo — Cairo
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 N
Identifiers
NCT: NCT07395895 · IRB00014233-66