Effect of Metformin Iontophoresis on Knee Osteoarthritis in Postmenopausal Women

ConditionOsteoarthritis in Postmenopausal Women

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age50-70

SponsorBadr University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

Metformin gel Iontophoresis
Drug
Metformin gel 2% Iontophoresis Combined with Physical Therapy Rehabilitation
Iontophoresis
Device
Iontophoresis with neutral gel Combined with Physical Therapy Rehabilitation

Treatment groups

68 Participants

are divided into 2 treatment groups

Group A: Metformin IontophoresisActive comparator 1 intervention

Group B: Iontophoresis Combined with Physical Therapy RehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Pain intensity

assessed using the Visual Analog Scale.

Time frame

at baseline, after 6 weeks and after 12 weeks

Functional status

assessed using the WOMAC index

Time frame

at baseline, after 6 weeks and after 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Badr University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: