Effect of Metformin Iontophoresis Combined With Physical Therapy Rehabilitation on Knee Osteoarthritis in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •• 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.
研究组 & 干预措施
Metformin Iontophoresis
干预措施: Metformin gel Iontophoresis (Drug)
Iontophoresis Combined with Physical Therapy Rehabilitation
干预措施: Iontophoresis (Device)
结局指标
主要结局
Pain intensity
时间窗: at baseline, after 6 weeks and after 12 weeks
assessed using the Visual Analog Scale.
Functional status
时间窗: at baseline, after 6 weeks and after 12 weeks
assessed using the WOMAC index
次要结局
未报告次要终点
研究者
Eman Said Sawan
Lecturer
Badr University