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

Not Applicable

Recruiting

• Conditions: Leg Injury
• Interventions: Other: Psychologically Informed Education Video Series; Other: Anatomy and biomedical education videos

• Registration Number: NCT05701618
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-27
• Study Start: 2023-01-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2026-01-23
• Study Completion: 2026-01-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychologically Informed Education	Psychologically Informed Education Video Series	is arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with atraumatic lower extremity injuries.
Control Education	Anatomy and biomedical education videos	This arm will provide education of basic leg anatomy and will not address maladaptive psychological behaviors.

Primary Outcome Measures

Name	Time	Method
Change in Numeric Pain Rating Scale	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.
Change in Lower Extremity Function Scale.	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.
Change in physical activity levels as measure by activity monitor	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 Outcome Measures

Name	Time	Method
Change in Kinesiophobia	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.
Change in Fear-Avoidance Beliefs	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.
Change in Pain Catastrophizing	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
Change in Pain Self Efficacy Questionnaire	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

Trial Locations

Locations (1)

Nationwide Children's Hospital Sports and Ortho Physical Therapy; 🇺🇸 Columbus, Ohio, United States