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

March 16, 2026 updated by: Mitchell Selhorst, Nationwide Children's Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Nationwide Children's Hospital Sports and Ortho Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Psychologically Informed Education
is arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with atraumatic lower extremity injuries.
Other: Psychologically Informed Education Video Series
A short three video series (5-8.5 minutes each) provides psychologically-informed education at an age-appropriate level to address kinesiophobia, pain catastrophizing, and fear-avoidance beliefs.30 Participants will view the three-part education video series on an iPad at their first visit (video 1), one week (video 2), and three weeks (video 3).
Placebo Comparator: Control Education
This arm will provide education of basic leg anatomy and will not address maladaptive psychological behaviors.
Other: Anatomy and biomedical education videos
Participants in the control group will watch three videos equal in length to the psychologically-informed videos. The control videos will discuss anatomy of the lower extremity, basic instruction in proper lower extremity biomechanics, and simple lower extremity exercises. The control videos will provide no psychologically-informed education or positive reinforcement about the condition.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Lower Extremity Function Scale.
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year
The lower extremity function scale is a 20-item self-report questionnaire used to evaluate functional ability during everyday tasks (0-80). Each item is scored on a 0-4 point scale with higher scores representing greater functional ability. The lower extremity function scale has validity in the adolescent population and has a minimal clinical important difference of 9 points.
Baseline, 1 month, 3 months, 6 months, 1 year
Change in Numeric Pain Rating Scale
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year
The numeric pain rating scale asks the patient their highest pain in the last 24 hours. The Numeric Pain Rating Scale is a 0-10 scale subjectively assessing a patients perceived level of pain. With 0 on the scale = to no pain, and 10 = to the worst pain imaginable. The use of the Numerical Pain Rating Scale for assessing pain has been validated for use in patients with knee pain and has been found to have a minimal detectable change of 1 points.
Baseline, 1 month, 3 months, 6 months, 1 year
Change in physical activity levels as measure by activity monitor
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year
Physical activity levels will be assessed with a wearable activity monitor: Total energy expenditure will be assessed using the Fitbit Inspire 3(TM) with Heart Rate Monitoring over a seven-day period. The Fitbit Inspire 3 (TM) is a wrist-worn activity monitor that demonstrates acceptable validity and reliability for assessing total energy expenditure. Higher levels of total energy expenditure levels represent higher levels of physical activity.
Baseline, 1 month, 3 months, 6 months, 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Fear-Avoidance Beliefs
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year
Fear avoidance beliefs as measured by the Fear Avoidance Beliefs Questionnaire-Physical Activity Subscale. The Fear Avoidance Beliefs Questionnaire-Physical Activity Subscale is a 4-item self-report questionnaire (0-24). Each item is scored 0-6 with higher scores representing higher levels of fear-avoidance beliefs.
Baseline, 1 month, 3 months, 6 months, 1 year
Change in Kinesiophobia
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year
Change in kinesiophobia beliefs as measure by the Tampa Scale for Kinesiophobia-11. The Tampa Scale of Kinesiophobia-11 is an 11 item self-report questionnaire (11-44 scale). Ratings range from 1 (strongly disagree) to 4 (strongly agree). Higher scores represent higher levels of kinesiophobia.
Baseline, 1 month, 3 months, 6 months, 1 year
Change in Pain Catastrophizing
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year
Change in pain catastrophizing as measured by the pain catastrophizing scale-child version. The Pain Catastrophizing Scale-child is a 13-item self-report measure (0-52). Each item is rated on a 5-point scale, ranging from 0 (not at all) to 4 (all the time). With higher scores representing higher levels of pain catastrophizing
Baseline, 1 month, 3 months, 6 months, 1 year
Change in Pain Self Efficacy Questionnaire
Time Frame: Baseline, 1 month, 3 months, 6 months, 1 year
The Pain Self Efficacy Questionnaire is a 10-item scale which assesses confidence in functioning despite pain. Each item is scored 0-6 with higher scores representing higher levels of pain self-efficacy (0-60). The PSEQ was originally designed for adults but has been found valid and reliable for adolescents
Baseline, 1 month, 3 months, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nationwide Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mitchell Selhorst, DPT, PhD, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Access Criteria

As a part of this research, it will be necessary to collect identifying information. Even though the final dataset will be stripped of identifiers prior to release for sharing, the patient sample is composed of minors who are a protected patient population Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Aggregate data including sample means, standard deviations, frequencies and significance values will be shared through peer-reviewed publications and conference abstracts. Email requests for data-sharing agreements to Mitchell.Selhorst@Nationwidechildrens.org

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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