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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urtica dioica cataplasm | Experimental | Topical application of Urtica dioica cataplasm |
|
| Standard Care Group | Active Comparator | Oral vitamin D supplementation and physical rest |
|
| Placebo | Placebo Comparator | Topical application of a placebo cataplasm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At each clinical visit during the intervention period (three times a week during 6 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Assessments will be done at baseline and after 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events (skin reactions, discomfort, or other clinical complaints) will be recorded systematically. | At each follow-up visit during 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
Male
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amira Zairi, Pr. | Contact | +21698424285 | zairi_amira@yahoo.fr | |
| Hana Nasrallah, PhD | Contact | hananasrallah.hn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amira Zairi | Department of Biochemistry, Faculty of Medicine of Sousse, University of Sousse, Tunisia | Study Director |
| Sahbi El Mtaoua | Department of Physical Medicine and Rehabilitation, Hospital Ibn Jazzar of Kairouan, University of Sousse, Tunisia |
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| ID | Term |
|---|---|
| D055034 | Osteochondrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| 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. |
|
| Return to sport |
defined as the number of days post-treatment needed to resume regular athletic activity. |
| 6 weeks |