Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain

Study Overview
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Brief Summary
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This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with patellofemoral pain. A set of psychosocial surveys assessing fear avoidance beliefs, kinesiophobia, and pain catastrophizing will be completed by the participant/parents. Participants will then complete an activity questionnaire, numeric pain rating scale, and a self-report questionnaire of functional ability. Participants will then be randomized into one of two groups (psychologically informed education group and a control group). Participants will view a series of educational videos (based upon group assignment) and complete physical therapy exercises for lower extremity strengthening, flexibility, and neuromuscular control. Participants with patellofemoral pain will then complete follow-up surveys of their psychosocial beliefs, pain and self-reported functional ability through REDcap at immediately post-intervention, 1 week, 3 weeks, 6 weeks, and 3 months.

Official Title
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Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain

Conditions
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Patellofemoral Pain Syndrome, Knee Pain Chronic, Patellofemoral Syndrome, Anterior Knee Pain Syndrome

Intervention / Treatment
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* Other: Psychologically Informed Education
* Other: Biomedical Education (Control)


Participation Criteria
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Eligibility Criteria
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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: Prior history of patellar dislocation. Suspicion of other diagnosis of the knee by evaluating physical therapist or principal investigator. Other concomitant injury of the leg. Prior history of knee surgery. 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). Numbness and tingling in any lumbar dermatome.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychologically Informed Video Series<br>This 3 part educational video series 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); Simple methods of cognitive restructuring; and how to respond to activity-related pain. | Other: Psychologically Informed Education<br>* This arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with knee pain<br>|
| Active Comparator: Biomedical Education Video Series<br>Participants in the control (biomedical education) group will watch a series videos on the iPad equal in length to the psychologically informed video series. The control video will discuss basic anatomy of the knee and provide no psychosocial education or positive reinforcement about their condition, basic strengthening exercises and proper lower extremity mechanics | Other: Biomedical Education (Control)<br>* This arm will provide education of basic knee anatomy, lower extremity mechanics, and simple exercises and will not address maladaptive psychological behaviors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anterior Knee Pain Scale | Assessment 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 8-10 points represent the minimal clinical difference (Crossley, 2004). | Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numeric Pain Rating Scale | The 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. | Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months] | 
| Change in self-reported physical activity level. | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Activity. PROMIS physical activity scale assesses activity over the past week. Each question has five response options ranging in value from 1 to 5. The responses are summed with scores ranging from 8-40 with 8 representing the lowest physical activity and 40 representing the highest physical activity. Raw scores are rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. | Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months] | 
| Change in Fear-Avoidance Beliefs | Change in fear avoidance beliefs as measure by the Fear Avoidance Beliefs Questionnaire Physical Activity scale (FABQ-PA). The FABQ-PA quantifies the patient's fear of pain and beliefs about avoiding activity. The FABQ-PA is a 5-item self-report measure which assesses an individual's fear-avoidance of painful activity and is modified for the knee. The FABQ-PA is modified by changing the word back to knee on the questionnaire. Each item is scored on a 0-6 scale, with 0 indicating completely disagree and 6 indicating completely agree. Questions 2-5 are summed to create a final score of 0-24, with high scores indicating higher fear avoidance beliefs. | Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months] | 
| Change in Kinesiophobia | Change in kinesiophobia beliefs as measure by the Tampa Scale for Kinesiophobia-11 scale. The TSK-11 is an 11-item questionnaire that assesses fear of injury due to movement. Patients are asked to make ratings of their degree of agreement with each of the 11 statements, for instance, 'Pain lets me know when to stop exercising so that I don't injure myself'. Ratings range from 1 (strongly disagree) to 4 (strongly agree). The responses are summed to yield a total score of 11-44 where higher values reflect higher kinesiophobia. | Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months] | 
| Change in Pain Catastrophizing | Change in pain catastrophizing as measured by the pain catastrophizing scale-child version (PCS-c). The PCS-c is a 13-item self-report measure designed to assess a child's pain catastrophizing. Each item is rated on a 5-point scale, ranging from 0 (not at all) to 4 (all the time). The responses are summed to yield a total score of 0-52 where higher values reflect higher pain catastrophizing. | Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee, Adolescent, Psychologically-informed, Anterior Knee Pain