Combined Effect of Prolotherapy and Personalized Physical Activity on Knee Osteoarthritis Progression, Impact on IL-1β, MMP-3 Biomarkers and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
研究概览
简要总结
The aim of this clinical trial is to assess whether prolotherapy combined with personal physical activity is effective in managing pain (measured using the VAS and WOMAC scales) and improving the quality of life in participants with Grade 2 Knee Osteoarthritis (OA).
This trial will also measure the levels of IL-1β and MMP-3 in the participants. The primary research questions are:
- Does prolotherapy combined with personal physical activity reduce pain levels and improve clinical outcomes in participants with knee OA compared to those receiving prolotherapy ?
- How does this intervention affect the levels of IL-1β and MMP-3 in participants?
Researchers will compare prolotherapy combined with personal physical activity to prolotherapy alone to determine its impact on clinical outcomes and changes in biomarkers in patients with knee OA.
详细描述
The objective of this clinical trial is to evaluate the levels of IL-1β and MMP-3, clinical outcomes related to pain (measured using the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)), as well as the quality of life in participants with knee osteoarthritis (OA) who are treated with pain management through prolotherapy combined with personalized physical activity. This trial aims to develop a complementary therapy or an alternative treatment option that is cost-effective, accessible, and potentially more affordable for the broader population.
Study Design/Methods:
This study will utilize a Randomized Controlled Trial (RCT) design with pre- and post-test assessments.
Group/Arm :
- Experimental Group (Prolotherapy and Personalized Physical Activity Program)
- Active Comparator/Control (Prolotherapy only)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years with primary knee osteoarthritis (OA) diagnosed by ultrasonography who provided written informed consent.
- •Participants were required to be cooperative and capable of complying with the study protocol
排除标准
- •A history of traumatic knee arthritis
- •Knee OA associated with trauma, fracture, ankylosing spondylitis, or septic arthritis
- •Major comorbidities significantly impairing quality of life (e.g., cancer, heart failure, renal failure, stroke)
- •Use of NSAIDs or systemic steroids within 1 week
- •Intra-articular corticosteroid injection within 2 months; or current use of injectable or hormonal contraception.
研究者
muhammad yusuf hisam
Principal Investigator
Gadjah Mada University