Psychologically Informed Education for Leg Injury

Overseen By Mitchell Selhorst, DPT, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: Tendon tear, Fracture, Surgery, Neurologic, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how psychological factors like stress and anxiety affect pain and physical activity in teenagers with ongoing leg pain. Researchers will divide participants into two groups: one will receive the Psychologically Informed Education Intervention, which addresses negative psychological behaviors, and the other will receive basic leg anatomy education. The goal is to determine if the special education program can improve pain levels, quality of life, and physical activity. Teens aged 12 to 17 who have experienced leg pain for more than four weeks without a recent injury are ideal candidates for this study. As an unphased trial, this study offers participants a unique opportunity to contribute to understanding the psychological aspects of pain management in teenagers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this psychologically informed education intervention is safe for adolescents with leg pain?

Research shows that educational videos are generally safe for teenagers. Studies have found that these videos, when combined with physical therapy, help improve knee pain in teens. No major safety issues or serious side effects have been reported. This treatment targets psychological factors and is non-invasive, avoiding surgery or other procedures. The study is in a phase called "Not Applicable," indicating that the treatment is considered low-risk and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Psychologically Informed Education Intervention because it uniquely targets the psychological factors that can hinder recovery from atraumatic leg injuries in adolescents. Unlike standard treatments that focus solely on physical rehabilitation, this approach addresses maladaptive psychological behaviors, helping patients build healthier mental strategies alongside their physical healing. By integrating psychological education with injury care, this intervention aims to improve overall recovery outcomes, offering a more holistic approach than traditional methods.

What evidence suggests that the Psychologically Informed Education Intervention could be effective for leg pain?

This trial will compare a Psychologically Informed Education intervention with a Control Education approach. Research has shown that educational videos, like those used in the Psychologically Informed Education arm of this trial, can help teenagers with leg pain. When combined with physical therapy, these videos improve movement in young people with patellofemoral pain, a common knee issue. The videos focus on changing negative thoughts and behaviors that might worsen the pain. By helping teens think and feel differently about their pain, these videos can enhance physical performance and quality of life. This suggests that these educational videos could effectively manage leg pain in teenagers. ^{1 3 4 6 7}

Who Is on the Research Team?

Mitchell Selhorst, DPT, PhD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 12 and 17 years old.

I have had pain in my legs for over 4 weeks without injury.

Exclusion Criteria

I have a broken bone in my leg or foot.

I experience numbness and tingling in my lower back area.

Suspicion or evidence of complete tendon or ligamentous tear

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete psychosocial surveys and self-report questionnaires assessing pain, quality of life, and functional ability, followed by an assessment of physical activity levels with a wearable activity monitor.

1 week

Intervention

Participants are randomized into either a psychologically-informed video education group or a control group, and receive their assigned educational intervention.

1 week

Follow-up

Participants complete follow-up assessments of psychological beliefs, pain, quality of life, physical activity levels, and self-reported functional ability at multiple time points.

1 year

Follow-up assessments at 1 week, 4 weeks, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Psychologically Informed Education Intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: Psychologically Informed Education Experimental Treatment 1 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 Education Placebo Group 1 Intervention

This arm will provide education of basic leg anatomy and will not address maladaptive psychological behaviors.

Psychologically Informed Education Intervention is already approved in United States for the following indications:

Approved in United States as Psychologically Informed Education Intervention for:

• Pain management in adolescents with atraumatic lower-extremity injuries
• Improvement of psychological beliefs and self-reported function in adolescents with anterior knee pain

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Published Research Related to This Trial

A study involving 125 patients with musculoskeletal trauma showed that a 30-minute educational intervention significantly reduced pain and anxiety levels, and improved self-efficacy during hospitalization compared to usual care.

The educational intervention, which included coping strategies and relaxation exercises, could be beneficial for patients undergoing orthopedic surgery and should be considered for routine preoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an educational intervention on levels of pain, anxiety and self-efficacy for patients with musculoskeletal trauma. Wong, EM., Chan, SW., Chair, SY.[2022]

Psychologically informed practice encourages athletic trainers to adopt a biopsychosocial approach, addressing both physical injuries and the mental health aspects of athletes, which can improve overall patient management.

The paper outlines effective patient-reported outcome measures for screening mental health symptoms and provides recommendations for psychological interventions, emphasizing the importance of appropriate referrals to mental health professionals for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Clinical Concepts: Integration of Psychologically Informed Practice for Management of Patients With Sport-Related Injuries. Baez, S., Jochimsen, K.[2023]

The study observed four experienced physiotherapists working with groups of chronic pain patients, identifying key therapeutic intentions such as building a therapeutic alliance and fostering self-efficacy, which align with cognitive-behavioral therapy (CBT) competencies.

The findings highlight the importance of psychologically informed practice (PIP) in physiotherapy, suggesting that training and mentoring for physiotherapists could enhance their ability to deliver effective psychological interventions in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of psychologically informed practice: observations of experienced physiotherapists working with people with chronic pain. Denneny, D., Frijdal Nee Klapper, A., Bianchi-Berthouze, N., et al.[2020]

The new 'psychologically informed practice' approach in physical therapy integrates psychological factors into treatment, aiming to prevent unnecessary pain-related activity limitations by considering 'yellow' and 'blue flags' that indicate risks for poor outcomes.

This approach is seen as an evolution of traditional physical therapy, enhancing therapists' existing skills by systematically addressing psychosocial factors that influence treatment outcomes, and has been positively received in training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychologically informed practice for management of low back pain: future directions in practice and research. Main, CJ., George, SZ.[2022]

The Concept of Pain Inventory (COPI) was used to assess pain beliefs in a cohort of 127 youth and their parents, revealing that parents generally had a better understanding of contemporary pain science than the youth.

A significant conceptual gap was identified, particularly the belief that 'Learning about pain can help you feel less pain,' which was the least endorsed by both groups, indicating a critical area for targeted pain science education to improve engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Pain Science Education in Youth With Chronic Pain: What Are the Sticking Points for Youth and Their Parents? Pate, JW., Harrison, LE., Hess, CW., et al.[2023]

A qualitative study involving 15 adult patients revealed that while participants found a pain science educational video helpful for understanding their pain and facilitating communication with healthcare providers, it often left them with unanswered questions.

Participants experienced a range of emotional responses to the video, highlighting the importance of personal relevance and validation of their pain, suggesting that future pain education should address these emotional aspects more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of patients with chronic pain about a pain science education video. Dannecker, EA., Royse, LA., Vilceanu, D., et al.[2022]

Psychologically informed practice (PIP) for low back pain emphasizes understanding patients' beliefs and behaviors regarding pain, which can help predict their recovery and prevent chronic pain, moving beyond traditional biomechanical approaches.

PIP has gained traction in recent years, being integrated into large trials and clinical practice, aligning with national priorities for nonpharmacological pain management, and showing promise in improving outcomes for patients at high risk of persistent pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Psychologically Informed Practice for Patients With Persistent Musculoskeletal Pain: Promise, Pitfalls, and Solutions. Keefe, FJ., Main, CJ., George, SZ.[2022]

A 15-minute educational video significantly improved patients' understanding of the enhanced recovery program (ERP) for colorectal surgery, with 88% of patients finding the video information adequate and 28% considering it very helpful.

The study, involving 32 patients, showed that using the video did not lead to any major postoperative complications or readmissions, suggesting that this method of psychological preparation can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation for elective colorectal surgery using a video: a questionnaire-based observational study. Ihedioha, U., Sangal, S., Mastermann, J., et al.[2021]

An educational video aimed at chronic pain patients successfully modified their understanding of pain, shifting their perspective from a purely medical model to a more comprehensive multimodal approach that includes psychological factors.

The study involved 89 chronic pain patients (47 from a pain ambulance and 42 from an inpatient clinic), and the results indicated that the video effectively changed patients' attitudes towards pain management, promoting more realistic expectations about treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pain concept modification in chronic pain patients by an educational video.]. Kröner-Herwig, B., Lucht, S.[2021]

A study involving 31 patients with lower limb amputations revealed that most experienced phantom pain, but the information provided to them about this condition varied widely, with some receiving little to no guidance.

Patients expressed a strong need for timely and clear information about phantom pain, preferring verbal explanations from healthcare professionals, particularly nurses and surgeons, to help manage their pain effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient information on phantom limb pain: a focus group study of patient experiences, perceptions and opinions. Mortimer, CM., Steedman, WM., McMillan, IR., et al.[2019]

Citations

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A series of brief, psychologically informed educational videos added to physical therapy improved function among adolescents with patellofemoral pain.

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clinicaltrial.be

clinicaltrial.be/nl/details/189882?per_page=100&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Psychologically Informed Education Intervention for Adole...

This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with leg pain.

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A series of brief, psychologically informed educational videos added to physical therapy improved function among adolescents with patellofemoral pain.

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nsuworks.nova.edu/context/hpd_facarticles/article/1267/viewcontent/selhorst_et_al_2023_the_effect_of_a_psychologically_informed_video_series_to_treat_adolescents_patellofemoral_pain_a.pdf

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The effect of a psychologically informed video series to treat adolescents' patellofemoral pain: A randomized controlled trial. Mitchell ...

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The Effect of Psychologically Informed Education in ...

This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with anterior knee ...

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withpower.com/trial/phase-wounds-and-injuries-2023-ae51c

Psychologically Informed Education for Leg Injury

This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with leg pain.

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researchgate.net

researchgate.net/publication/373944803_The_effect_of_a_psychologically_informed_video_series_to_treat_adolescents'_patellofemoral_pain_A_randomized_controlled_trial

The effect of a psychologically informed video series to ...

OBJECTIVE: To test whether a series of brief, psychologically informed educational videos added to physical therapy improved function among ...