Psychologically Informed Education for Leg Injury
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Intervention
Participants are randomized into either a psychologically-informed video education group or a control group, and receive their assigned educational intervention.
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.
Treatment Details
Interventions
- Psychologically Informed Education Intervention
Psychologically Informed Education Intervention is already approved in United States for the following indications:
- 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