Evaluation of Safety and Efficacy of Urtica Dioica Cataplasm in the Management of Osgood-Schlatter Disease in Young Athletes: A Study Protocol for Randomized, Double-blind, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Pain intensity
研究概览
简要总结
The primary objective of this clinical trial is to evaluate the efficacy and safety of a topical Urtica dioica cataplasm in managing knee pain and functional limitations in athletic children diagnosed with Osgood-Schlatter Disease. Efficacy will be assessed through changes in knee pain using the Visual Analog Scale (VAS) and functional outcomes using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Three groups will be tested:
- UDC Group: topical application of Urtica dioica cataplasm
- Standard Care Group: oral vitamin D supplementation and physical rest
- Placebo Group: topical application of a placebo cataplasm using Beta vulgaris subsp. cicla
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, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy male children between 7 and 15 years of age
- •Active in regular sports practice (e.g., football)
- •Clinically confirmed diagnosis of OSD
排除标准
- •Known allergy to Urtica dioica
- •Presence of dermatological conditions or lesions on the knees
- •Recent use of anti-inflammatory medications
- •History of immune or chronic inflammatory diseases
- •Diagnosis of any other bone disorder
研究组 & 干预措施
Urtica dioica cataplasm
Topical application of Urtica dioica cataplasm
干预措施: Urtica dioica cataplasm (Other)
Standard Care Group
Oral vitamin D supplementation and physical rest
干预措施: Vitamin D (Drug)
Standard Care Group
Oral vitamin D supplementation and physical rest
干预措施: Resting conditions (Behavioral)
Placebo
Topical application of a placebo cataplasm
干预措施: Placebo (Other)
结局指标
主要结局
Pain intensity
时间窗: At each clinical visit during the intervention period (three times a week during 6 weeks).
measured using the Visual Analog Scale (VAS), a 10-cm line anchored by "no pain" (0) and "worst imaginable pain" (10). VAS scores will be recorded at each clinical visit during the intervention period.
次要结局
- Functional knee status(Assessments will be done at baseline and after 6 weeks.)
- Return to sport(6 weeks)
研究者
Amira Zairi
Professor
Faculty of Medicine, Sousse