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Recruiting
NCT05701618
Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries
Conditions: Leg Injury
Sex: All
Ages: 12 Years – 18 Years
Phase: NA
Enrollment: 86
Sponsor: Nationwide Children's Hospital
Location: United States
Summary
This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with leg pain.
A set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participants.
Participants will then complete self-report questionnaires assessing pain, quality of life and functional ability followed by an assessment of physical activity levels assessed with a wearable activity monitor;.
Participants will then be randomized into one of two intervention groups (psychologically-informed video education group and a control group).
After participants receive their assigned educational intervention, the self-report questionnaires will be re-administered.
Participants with leg pain pain will then complete follow-up assessment of their psychological beliefs, pain, quality of life, physical activity levels, and self-reported functional ability through REDcap at 1 week, 4 weeks, 3 months, 6 months, and 1 year.
Eligibility Criteria
Inclusion criteriaAge between 12 and 17 yearsAtraumatic lower extremity pain for >4 weeksExclusion criteriaSuspicion or evidence of complete tendon or ligamentous tear.Current fracture in the lower extremity.Prior history of surgery in the lower extremity.Neurologic or developmental disorder, which alters lower extremity function.Numbness and tingling in any lumbar dermatome.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).
Source: ClinicalTrials.gov (NCT05701618). StuddyBuddy aggregates publicly available trial information.