Safety and Efficacy of Urtica Dioica Cataplasm in the Management of Osgood-Schlatter Disease in Young Athletes
- Conditions
- Osgood-Schlatter Disease
- Interventions
- Registration Number
- NCT07096037
- Lead Sponsor
- Faculty of Medicine, Sousse
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 90
- Healthy male children between 7 and 15 years of age
- Active in regular sports practice (e.g., football)
- Clinically confirmed diagnosis of OSD
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Urtica dioica cataplasm Urtica dioica cataplasm Topical application of Urtica dioica cataplasm Standard Care Group Vitamin D Oral vitamin D supplementation and physical rest Standard Care Group Resting conditions Oral vitamin D supplementation and physical rest Placebo Placebo Topical application of a placebo cataplasm
- Primary Outcome Measures
Name Time Method Pain intensity 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.
- Secondary Outcome Measures
Name Time Method Functional knee status Assessments will be done at baseline and after 6 weeks. assessed using the KOOS-Child questionnaire, covering five subscales (pain, symptoms, activities of daily living, sport/recreation function, and knee-related quality of life). Scores range from 0 (extreme dysfunction) to 100 (no symptoms).
Return to sport 6 weeks defined as the number of days post-treatment needed to resume regular athletic activity.