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Completed

NCT Number: NCT05701618

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

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.

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Key information

Conditions

Leg Injury Leg Injuries Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital Sports and Ortho Physical Therapy

Columbus, Ohio, 43215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 12 and 17 years
  • Atraumatic lower extremity pain for >4 weeks

Exclusion criteria

  • Suspicion 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).

Treatment and study plan

Psychologically Informed Education Video Series

Other

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).

Anatomy and biomedical education videos

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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