Comparative Effects of Intra-articular Dextrose Prolotherapy and Intra-articular Triamcinolone Acetonide on Pain and Function in Knee Osteoarthritis: A Randomized Controlled Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- 2.To evaluate the changes in functional outcomes in WOMAC following dextrose prolotherapy compared to triamcinolone acetonide injections
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of intra-articular dextrose prolotherapy versus intra-articular triamcinolone acetonide injection in patients with knee osteoarthritis. The study evaluates outcomes related to pain reduction, joint function, quality of life, and muscle parameters. The hypothesis is that dextrose prolotherapy provides longer-lasting pain relief and functional improvement compared to corticosteroid injections. A total of 112 participants will be randomly assigned to either intervention. Assessments will include Visual Analog Scale (VAS), WOMAC index, SF-36, ultrasound-based muscle thickness, and surface EMG analysis. Follow-up will be conducted over 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 78.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 years or older Radiologically confirmed knee osteoarthritis (Kellgren-Lawrence Grade II to IV) Experiencing moderate to severe knee pain Able to walk unassisted or with minimal assistance Willing to participate in the study, receive injections, and attend follow-up visits.
排除标准
- •Previous knee surgery within the past 6 months Presence of inflammatory joint diseases (e.g., rheumatoid arthritis) Active infection in or around the knee joint Known allergy to dextrose or triamcinolone acetonide Untreated blood clotting disorders Pregnancy or breastfeeding.
结局指标
主要结局
2.To evaluate the changes in functional outcomes in WOMAC following dextrose prolotherapy compared to triamcinolone acetonide injections
时间窗: (Week 0), Week 4, Week 12, and Week 24
1.To assess the change in pain scores between the dextrose prolotherapy and triamcinolone acetonide groups in VAS score
时间窗: (Week 0), Week 4, Week 12, and Week 24
次要结局
- I.To monitor and compare the incidence of adverse events between the dextrose prolotherapy and triamcinolone acetonide groups.(II.To assess quality of life in SF 36 scale outcomes following dextrose prolotherapy versus triamcinolone acetonide injections.)