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NCT Number: NCT07096037

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

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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Key information

Conditions

Osgood-Schlatter Disease Bone Diseases Musculoskeletal Diseases Osteochondrosis

Age range

7 year–15 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain intensity

    Time frame: 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

  1. Functional knee status

    Time frame: 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).

  2. Return to sport

    Time frame: 6 weeks

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

Other outcomes

  1. Adverse events

    Time frame: At each follow-up visit during 6 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Zairi, Pr.

CONTACT

[email protected]

+21698424285

Hana Nasrallah, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Faculty of Medicine, Sousse

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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