ClinicalTrials.Veeva

Menu

The Effect of Psychologically Informed Education in Adolescents With Patellofemoral Pain

Nationwide Children's Hospital logo

Nationwide Children's Hospital

Status

Completed

Conditions

Anterior Knee Pain Syndrome
Patellofemoral Pain Syndrome

Treatments

Other: Psychologically Informed Education Video
Other: Anatomy Education Video

Study type

Interventional

Funder types

Other

Identifiers

NCT03897907
IRB18-00724

Details and patient eligibility

About

This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with anterior knee pain. A set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participant/parents. Participants will then complete clinical tests of physical performance, numeric pain rating scale, and a self-report questionnaire of functional ability. Participants will then be randomized into one of two psychosocial intervention groups (psychologically informed education group and a control group). After participants receive their assigned education intervention, the clinical tests of pain and self-reported functional ability will be readministered. Participants with anterior knee pain will then complete follow-up surveys of their psychosocial beliefs, pain and self-reported functional ability through REDcap at immediately post-intervention, 2 weeks, 6 weeks, and 3 months.

Full description

This study will be a prospective randomized controlled trial design. Participants will complete the randomized intervention immediately after completing baseline testing. Post-intervention testing will also be completed immediately after the randomized intervention. A follow-up REDcap survey will be sent by email to assess function and pain at 2 weeks, 6 weeks and 3 months.

Intervention Psychologically Informed Education Group Psychologically Informed Education Medium There are many ways to provide patient education, but the investigators believe that adolescents will respond well to video education on a tablet. Adolescents are extremely comfortable with this technology, and the video will allow for standardized education among all participants.

Development of Psychologically Informed Education for adolescents with AKP Recommended adult pain science education will be modified using published recommendations for the adolescent population and tailored to anterior knee pain.(Robins, Perron, Heathcote, & Simons, 2016) The education session will teach participants how the body processes nociception and experiences pain, and pain does not mean tissues are being damaged. Additionally the psychologically informed education video will use the framework called the "Common Sense Model of Self-Regulation" which advocates for education to address five cognitive dimensions: (1) identity (the effort to evaluate symptoms and label the illness); (2) cause (the subjectively formulated belief of what is causing the symptoms); (3) time-line (the patient's perception of how long the problem will last); (4) consequences (the patient's predictions of how the illness will affect them in different areas of their life); and (5) controllability (the patient's belief regarding their outcome and personal ability to change it).(Leventhal, Phillips, & Burns, 2016) Control Group Participants in the control education group will watch a video on the iPad equal in length to the psychologically informed education video. The control video will discuss basic anatomy of the knee and provide no psychosocial education or positive reinforcement about their condition.

Enrollment

68 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Having patellofemoral pain as defined as: Pain around or behind the patella, which is aggravated by at least one activity that loads the patellofemoral joint during weight bearing on a flexed knee (e.g., squatting, stair ambulation, jogging/running, hopping/jumping)

Exclusion criteria

  1. Prior history of patellar dislocation.
  2. Suspicion of other diagnosis of the knee by evaluating physical therapist or principal investigator.
  3. Other concomitant injury of the leg.
  4. Prior history of knee surgery.
  5. 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).
  6. Numbness and tingling in any lumbar dermatome.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

68 participants in 2 patient groups, including a placebo group

Psychologically Informed Education
Experimental group
Description:
This arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with knee pain
Treatment:
Other: Psychologically Informed Education Video
Control Education
Placebo Comparator group
Description:
This arm will provide education of basic knee anatomy and will not address maladaptive psychological behaviors.
Treatment:
Other: Anatomy Education Video

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems