86 Participants Needed

Psychologically Informed Education for Leg Injury

MS
Overseen ByMitchell Selhorst, DPT, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Nationwide Children's Hospital
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Psychologically Informed Education Intervention, Psychologically Informed Video Education, Psychological Intervention for Pain Management?

Research shows that psychologically informed practices, like educational videos, can help change how people think about pain, making them more open to treatments that include psychological factors. This approach has been effective in managing chronic pain and musculoskeletal conditions by addressing patients' beliefs and expectations about pain.12345

Is Psychologically Informed Education for Leg Injury safe for humans?

The studies reviewed focus on the effectiveness of educational interventions for pain management, but they do not report any safety concerns or adverse effects, suggesting that these types of psychological education interventions are generally safe for humans.24678

How is the Psychologically Informed Education Intervention treatment different from other treatments for leg injuries?

This treatment is unique because it combines education with psychological strategies to help patients understand and manage their pain, focusing on changing their beliefs and attitudes about pain rather than just addressing physical symptoms. It uses educational videos to shift patients' perspectives towards a more comprehensive understanding of pain, incorporating psychological factors, which is different from traditional treatments that often focus solely on physical rehabilitation.123910

Research Team

MS

Mitchell Selhorst, DPT, PhD

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

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

Suspicion or evidence of complete tendon or ligamentous tear
I have a broken bone in my leg or foot.
I have had surgery on my leg before.
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Psychologically Informed EducationExperimental Treatment1 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 EducationPlacebo Group1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials
354
Recruited
5,228,000+

Findings from Research

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.
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]
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.
[Pain concept modification in chronic pain patients by an educational video.].Kröner-Herwig, B., Lucht, S.[2021]
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.
Advancing Psychologically Informed Practice for Patients With Persistent Musculoskeletal Pain: Promise, Pitfalls, and Solutions.Keefe, FJ., Main, CJ., George, SZ.[2022]

References

The application of psychologically informed practice: observations of experienced physiotherapists working with people with chronic pain. [2020]
[Pain concept modification in chronic pain patients by an educational video.]. [2021]
Advancing Psychologically Informed Practice for Patients With Persistent Musculoskeletal Pain: Promise, Pitfalls, and Solutions. [2022]
Effectiveness of an educational intervention on levels of pain, anxiety and self-efficacy for patients with musculoskeletal trauma. [2022]
Preparation for elective colorectal surgery using a video: a questionnaire-based observational study. [2021]
Perspectives of patients with chronic pain about a pain science education video. [2022]
Patient information on phantom limb pain: a focus group study of patient experiences, perceptions and opinions. [2019]
Targeting Pain Science Education in Youth With Chronic Pain: What Are the Sticking Points for Youth and Their Parents? [2023]
Current Clinical Concepts: Integration of Psychologically Informed Practice for Management of Patients With Sport-Related Injuries. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Psychologically informed practice for management of low back pain: future directions in practice and research. [2022]
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