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AzTrials

Leg InjuryNCT05701618

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

A study testing Psychologically Informed Education Video Series and Anatomy and biomedical education videos in people with Leg Injury, run by Nationwide Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Leg Injury
What is being tested?
Psychologically Informed Education Video Series and Anatomy and biomedical education videos
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteUnited States
Study dates
30 Jan 2023to 25 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Nationwide Children's Hospital Sports and Ortho Physical Therapy

    Columbus, Ohio, 43215

Other trials in United States

About this study

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.

Conditions
Leg Injury
Being tested
Psychologically Informed Education Video Series, Anatomy and biomedical education videos
Keywords
Adolescent, Atraumatic, Education, Patellofemoral, Tendinopathy, Apophysitis, Overuse
Medical subject headings
Leg Injuries, Tendinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychologically Informed Education Video SeriesOther

    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 videosOther

    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.

Study groups in NCT05701618
Study groupRoleWhat they receive
Psychologically Informed EducationExperimentalis arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with atraumatic lower extremity injuries.
Receives: Other: Psychologically Informed Education Video Series
Control EducationPlacebo comparatorThis arm will provide education of basic leg anatomy and will not address maladaptive psychological behaviors.
Receives: Other: Anatomy and biomedical education videos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Lower Extremity Function Scale.

    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.

    Measured: Baseline, 1 month, 3 months, 6 months, 1 year

  2. Change in Numeric Pain Rating Scale

    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.

    Measured: Baseline, 1 month, 3 months, 6 months, 1 year

  3. Change in physical activity levels as measure by activity monitor

    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.

    Measured: Baseline, 1 month, 3 months, 6 months, 1 year

Secondary outcomes (4)

  1. Change in Fear-Avoidance Beliefs

    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.

    Measured: Baseline, 1 month, 3 months, 6 months, 1 year

  2. Change in Kinesiophobia

    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.

    Measured: Baseline, 1 month, 3 months, 6 months, 1 year

  3. Change in Pain Catastrophizing

    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

    Measured: Baseline, 1 month, 3 months, 6 months, 1 year

  4. Change in Pain Self Efficacy Questionnaire

    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

    Measured: Baseline, 1 month, 3 months, 6 months, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start30 Jan 2023
  3. Primary completion25 Jun 2025
  4. Study completion25 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701618
Sponsor's protocol ID
STUDY00001170
Status last verified
Mar 2026
First submitted
18 Jan 2023
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

Publications

  • Holden S, Kasza J, Winters M, van Middelkoop M, Rathleff MS; Adolescent Knee Health Group. Prognostic factors for adolescent knee pain: an individual participant data meta-analysis of 1281 patients. Pain. 2021 Jun 1;162(6):1597-1607. doi: 10.1097/j.pain.0000000000002184.

    PubMed 33449504

  • Selhorst M, Hoehn J, Degenhart T, Schmitt L, Fernandez-Fernandez A. Psychologically-informed video reduces maladaptive beliefs in adolescents with patellofemoral pain. Phys Ther Sport. 2020 Jan;41:23-28. doi: 10.1016/j.ptsp.2019.10.009. Epub 2019 Oct 31.

    PubMed 31704460

  • Maclachlan LR, Collins NJ, Hodges PW, Vicenzino B. Psychological and pain profiles in persons with patellofemoral pain as the primary symptom. Eur J Pain. 2020 Jul;24(6):1182-1196. doi: 10.1002/ejp.1563. Epub 2020 Apr 12.

    PubMed 32223042

  • Coronado RA, Brintz CE, McKernan LC, Master H, Motzny N, Silva FM, Goyal PM, Wegener ST, Archer KR. Psychologically informed physical therapy for musculoskeletal pain: current approaches, implications, and future directions from recent randomized trials. Pain Rep. 2020 Sep 23;5(5):e847. doi: 10.1097/PR9.0000000000000847. eCollection 2020 Sep-Oct.

    PubMed 33490842

  • Yang X, Jago R, Zhang Q, Wang YY, Zhang J, Zhao WH. Validity and Reliability of the Wristband Activity Monitor in Free-living Children Aged 10-17 Years. Biomed Environ Sci. 2019 Nov;32(11):812-822. doi: 10.3967/bes2019.103.

    PubMed 31910939

  • Stahlschmidt L, Hubner-Mohler B, Dogan M, Wager J. Pain Self-Efficacy Measures for Children and Adolescents: A Systematic Review. J Pediatr Psychol. 2019 Jun 1;44(5):530-541. doi: 10.1093/jpepsy/jsz002.

    PubMed 30802913

Questions about this trial

What is this clinical trial studying?

A study testing Psychologically Informed Education Video Series and Anatomy and biomedical education videos in people with Leg Injury, run by Nationwide Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lower Extremity Function Scale. (time frame: Baseline, 1 month, 3 months, 6 months, 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701618, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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