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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin Iontophoresis | Active Comparator |
| |
| Iontophoresis Combined with Physical Therapy Rehabilitation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin gel Iontophoresis | Drug | Metformin gel 2% Iontophoresis Combined with Physical Therapy Rehabilitation |
|
| 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 |
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Inclusion Criteria:
• Postmenopausal women aged 50-70 years.
Exclusion Criteria:
• Severe knee osteoarthritis (Kellgren-Lawrence grade IV).
Postmenopausal Women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ‪Eman swan‬, Ph d | Contact | +201090111013 | eman.said@buc.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Badr University in Cairo | Cairo | 11829 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007478 | Iontophoresis |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004586 | Electrophoresis |
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| Iontophoresis | Device | Iontophoresis with neutral gel Combined with Physical Therapy Rehabilitation |
|
| D055664 |
| Electrochemical Techniques |
| D008919 | Investigative Techniques |