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Psychologically Informed Education for Leg Injury

N/A

Recruiting

Led By Mitchell Selhorst, DPT, PhD

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 months, 6 months, 1 year

Summary

This trial looks at how psychological factors can affect pain & physical performance in adolescents with leg pain. Surveys & activity monitors are used to measure the effects of treatment.

Who is the study for?

Adolescents aged 12-17 with leg pain lasting over 4 weeks can join this study. It's not for those with current fractures, complete tendon or ligament tears, symptoms suggesting non-muscle issues like infections, recent surgeries in the leg area, numbness in specific skin areas related to spine nerves, or neurological conditions affecting leg function.

What is being tested?

The trial is testing two types of educational videos: one set that includes psychological information and another focused on anatomy and biomedical facts. The goal is to see how these videos affect adolescents' pain perception, quality of life, and physical activity after a leg injury.

What are the potential side effects?

Since this trial involves educational videos rather than medical treatments or drugs, there are no direct side effects expected from participating. However, participants may experience varying emotional responses to the content.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 months, 6 months, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 months, 6 months, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, 6 months, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Lower Extremity Function Scale.

Change in Numeric Pain Rating Scale

Change in physical activity levels as measure by activity monitor

Secondary study objectives

Change in Fear-Avoidance Beliefs

Change in Kinesiophobia

Change in Pain Catastrophizing

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Psychologically Informed EducationExperimental Treatment1 Intervention

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

Group II: Control EducationPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out