Osgood-Schlatter Disease
Conditions
Keywords
Urtica dioica, Osgood-Schlatter disease, KOOS-Child, Visual Analogue Scale
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
Interventions
OTHERUrtica dioica cataplasm
Participants will receive a warm Urtica dioica cataplasm applied topically on the affected knee, once daily for 60 minutes, three times per week (on alternate days) over a 6-week period.
OTHERPlacebo
Participants will receive a placebo cataplasm, matched in texture, color, and odor to the active treatment. The placebo is inert and safe for pediatric topical use.
DRUGVitamin D
Participants will receive oral vitamin D.
BEHAVIORALResting conditions
Reduction in physical activity based on orthopedic advice.
Sponsors
Faculty of Medicine, Sousse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
7 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Healthy male children between 7 and 15 years of age * Active in regular sports practice (e.g., football) * Clinically confirmed diagnosis of OSD
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | At each follow-up visit during 6 weeks | Adverse events (skin reactions, discomfort, or other clinical complaints) will be recorded systematically. |
Contacts
Primary ContactAmira Zairi, Pr.
Backup ContactHana Nasrallah, PhD
Outcome results
None listed