Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries

Nationwide Children's Hospital

Status: Enrolling

Conditions: Leg Injury

Treatments: Other: Anatomy and biomedical education videos; Other: Psychologically Informed Education Video Series

Study type: Interventional

Funder types: Other

Identifiers

NCT05701618

STUDY00001170

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups, including a placebo group

Psychologically Informed Education

Experimental group

Description:

is arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with atraumatic lower extremity injuries.

Treatment:

Other: Psychologically Informed Education Video Series

Control Education

Placebo Comparator group

Description:

This arm will provide education of basic leg anatomy and will not address maladaptive psychological behaviors.

Treatment:

Other: Anatomy and biomedical education videos