An interventional study of Urtica dioica cataplasm and Placebo in Osgood-Schlatter Disease, sponsored by Faculty of Medicine, Sousse. Not yet recruiting. Open to male participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Faculty of Medicine, Sousse · Not applicable, Interventional, and Treatment
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:
16 studies on the registry are indexed under Osteochondrosis; 5 are open to participants now.
This study's planned enrollment of 90 is above the median of 51 across 13 interventional studies indexed under Osteochondrosis.
Browse Osteochondrosis studies →Faculty of Medicine, Sousse is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Topical application of Urtica dioica cataplasm
Other: Urtica dioica cataplasm
Oral vitamin D supplementation and physical rest
Drug: Vitamin D · Behavioral: Resting conditions
Topical application of a placebo cataplasm
Other: Placebo
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.
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.
Participants will receive oral vitamin D.
Reduction in physical activity based on orthopedic advice.
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).
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.
Return to sport
defined as the number of days post-treatment needed to resume regular athletic activity.
Time frame: 6 weeks
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Sep 2025, 0 months later.
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Faculty of Medicine, Sousse