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

ConditionOsgood-Schlatter Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age7-15
SponsorFaculty of Medicine, Sousse

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Healthy male children between 7 and 15 years of age

Active in regular sports practice (e.g., football)

Clinically confirmed diagnosis of OSD

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Urtica dioica cataplasm

    Other intervention

    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 intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Urtica dioica cataplasmExperimental treatment 1 intervention
Group B: Standard Care GroupActive comparator 2 interventions
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

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.

Time frame
At each clinical visit during the intervention period (three times a week during 6 weeks).

Secondary outcomes

1

Functional knee status

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).

Time frame
Assessments will be done at baseline and after 6 weeks.
2

Return to sport

defined as the number of days post-treatment needed to resume regular athletic activity.

Time frame
6 weeks

Other outcomes

1

Adverse events

Adverse events (skin reactions, discomfort, or other clinical complaints) will be recorded systematically.

Time frame
At each follow-up visit during 6 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Faculty of Medicine, Sousse

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: