Safety and Efficacy of Urtica Dioica Cataplasm in the Management of Osgood-Schlatter Disease in Young Athletes

NCT07096037 — Not applicable, Not yet recruiting, 90 participants, Faculty of Medicine, Sousse

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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

Registry	NCT07096037
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	90 (Estimated)
Sponsor	Faculty of Medicine, Sousse (Other)
Conditions	Osgood-Schlatter Disease
Interventions	Urtica dioica cataplasm, Placebo, Vitamin D, Resting conditions (Other, drug, behavioral)
Dates	start 2025-09-01 (estimated), primary completion 2025-09-15 (estimated), completion 2026-09-30 (estimated), first posted 2025-07-31, last updated 2025-08-01

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Urtica dioica cataplasm	Experimental	Other: Urtica dioica cataplasm	Topical application of Urtica dioica cataplasm
Standard Care Group	Active comparator	Drug: Vitamin D; Behavioral: Resting conditions	Oral vitamin D supplementation and physical rest
Placebo	Placebo comparator	Other: Placebo	Topical application of a placebo cataplasm

Urtica dioica cataplasm (Other): 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.
Placebo (Other): 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.
Vitamin D (Drug): Participants will receive oral vitamin D.
Resting conditions (Behavioral): Reduction in physical activity based on orthopedic advice.

+Outcome measures

Primary outcomes

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 outcomes

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 outcomes

Adverse events [At each follow-up visit during 6 weeks]: Adverse events (skin reactions, discomfort, or other clinical complaints) will be recorded systematically.

+Eligibility

Sex: Male, ages: 7 Years to 15 Years

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

+Investigators

Amira Zairi, Study director, Department of Biochemistry, Faculty of Medicine of Sousse, University of Sousse, Tunisia
Sahbi El Mtaoua, Principal investigator, Department of Physical Medicine and Rehabilitation, Hospital Ibn Jazzar of Kairouan, University of Sousse, Tunisia