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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Lower Extremity Function Scale.

Change in Numeric Pain Rating Scale

Change in physical activity levels as measure by activity monitor

Secondary outcome measures

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

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,420 Total Patients Enrolled

Mitchell Selhorst, DPT, PhDPrincipal InvestigatorNationwide Children's Hospital

Media Library

Psychologically Informed Education Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05701618 — N/A

Leg Injury Research Study Groups: Psychologically Informed Education, Control Education

Leg Injury Clinical Trial 2023: Psychologically Informed Education Intervention Highlights & Side Effects. Trial Name: NCT05701618 — N/A

Psychologically Informed Education Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05701618 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals under the age of 30 be included in this clinical research?

"This clinical trial seeks adolescent participants aged 12 to 18."

Answered by AI

Do I meet the criteria for taking part in this research endeavor?

"This medical study stipulates that potential participants must have a leg injury and be between 12 and 18 years old. In total, 86 patients may join the trial."

Answered by AI

Are there still openings for those wishing to take part in this research?

"According to the clinicaltrials.gov website, this trial is not actively recruiting at present; it was initially posted on January 23rd of 2023 and most recently updated on January 26th of 2023. Although this medical study is closed for enrollment, there are still 737 other trials seeking participants currently."

Answered by AI

What results is this research effort expected to yield?

"The primary metric of success for this study is the Change in Numeric Pain Rating Scale, which will be evaluated at Baseline, 1 month, 3 months and 6 months intervals. Secondary assessments include the Tampa Scale of Kinesiophobia-11 (a 11 point self-report questionnaire), the child version of the Pain Catastrophizing Scale (0 to 52 points) as well as a 10 item Pain Self Efficacy Questionnaire with scores ranging from 0 to 60."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mitchell Selhorst 2023. "Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05701618.

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