Education intervention for adolescents with leg injuries
Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries
This study is testing whether an educational video can help teenagers with leg injuries manage their pain and improve their physical performance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05701618 on ClinicalTrials.gov |
What this trial studies
This study evaluates how psychosocial factors influence pain and physical performance in adolescents suffering from atraumatic lower extremity injuries. Participants aged 12 to 17 will complete surveys on fear, stress, anxiety, and depression, followed by assessments of pain, quality of life, and physical activity levels using wearable monitors. They will then be randomized into two groups: one receiving a psychologically-informed educational video intervention and a control group. The impact of these interventions will be measured through follow-up assessments at various intervals.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 17 experiencing atraumatic lower extremity pain for more than four weeks.
Not a fit: Patients with complete tendon or ligament tears, current fractures, or significant neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve pain management and functional outcomes for adolescents with leg injuries.
How similar studies have performed: While similar psychosocial interventions have shown promise in other contexts, this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Age between 12 and 17 years 2. Atraumatic lower extremity pain for \>4 weeks Exclusion criteria 1. Suspicion or evidence of complete tendon or ligamentous tear. 2. Current fracture in the lower extremity. 3. Prior history of surgery in the lower extremity. 4. Neurologic or developmental disorder, which alters lower extremity function. 5. Numbness and tingling in any lumbar dermatome. 6. Red flags present for non-musculoskeletal involvement (bowel/bladder problems, saddle anesthesia, progressive neurological deficits, recent fever or infection, unexplained weight loss, unable to change symptoms with mechanical testing).
Where this trial is running
Columbus, Ohio
- Nationwide Children's Hospital Sports and Ortho Physical Therapy — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Mitchell Selhorst, DPT, PhD — Nationwide Children's Hospital
- Study coordinator: Mitchell Selhorst, DPT, PhD
- Email: Mitchell.Selhorst@Nationwidechildrens.org
- Phone: 6143559764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.