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The Effect of Psychologically Informed Education in Adolescents With Patellofemoral Pain

The Effect of Psychologically Informed Education in Adolescents With Patellofemoral Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03897907
Enrollment
68
Registered
2019-04-01
Start date
2019-04-05
Completion date
2022-06-30
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Knee Pain Syndrome, Patellofemoral Pain Syndrome

Brief summary

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.

Detailed 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.

Interventions

OTHERPsychologically Informed Education Video

The education session will teach participants how the body processes nociception and experiences pain, and pain does not mean tissues are being damaged. Additionally we 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)

OTHERAnatomy Education Video

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.

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

This research study is a double-blinded randomized controlled trial. The participants will not be made aware which education video they watch is the control and which is the intervention. The study staff will be blinded to group allocation until after measurements are completed.

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Anterior Knee Pain ScaleTime Frame: Baseline, 2 weeks (12-16 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 monthsAssessment of change of the Anterior Knee Pain Scale (AKPS). The AKPS is a self-reported 13 item questionnaire with discrete categories related to various levels of current knee function. Categories within each item are weighted, and responses are summed to provide an overall score of 0-100, with 100 representing no disability. The Anterior Knee Pain Scale is found to be valid and reliable in patients from 12-50 years of age presenting with anterior knee pain with a test-retest reliability of .95 (Watson, 2005). A change of 10 points represent the minimal clinical difference (Crossley, 2004).

Secondary

MeasureTime frameDescription
Change in Numeric Pain Rating ScaleTime Frame: Baseline, 2 weeks (12-16 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 monthsThe 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.
Change in Fear-Avoidance BeliefsTime Frame: Baseline, immediately post-intervention, 2 weeks (12-16 days post-evaluation),Fear avoidance beliefs as measured by the Fear Avoidance Beliefs Questionnaire-Physical Activity Subscale
Change in KinesiophobiaTime Frame: Baseline, immediately post-intervention, 2 weeks (12-16 days post-evaluation),Change in kinesiophobia beliefs as measure by the Tampa Scale for Kinesiophobia-11 scale
Change in Pain CatastrophizingTime Frame: Baseline, immediately post-intervention, 2 weeks (12-16 days post-evaluation),Change in pain catastrophizing as measured by the pain catastrophizing scale-child version

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026