Skip to main content
OpenTrials
Completed

NCT Number: NCT04752501

Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patellofemoral Pain Syndrome Anterior Knee Pain Syndrome Joint Diseases Knee Pain Chronic Musculoskeletal Diseases Patellofemoral Syndrome

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital Sports and Ortho PT East Broad

Columbus, Ohio, 43213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychologically Informed Education

Other

This arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with knee pain

Biomedical Education (Control)

Other

This arm will provide education of basic knee anatomy, lower extremity mechanics, and simple exercises and will not address maladaptive psychological behaviors

Primary outcomes

  1. Change in Anterior Knee Pain Scale

    Time frame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]

    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).

Secondary outcomes

  1. Change in Numeric Pain Rating Scale

    Time frame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]

    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.

  2. Change in self-reported physical activity level.

    Time frame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]

    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.

  3. Change in Fear-Avoidance Beliefs

    Time frame: 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 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.

  4. Change in Kinesiophobia

    Time frame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]

    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.

  5. Change in Pain Catastrophizing

    Time frame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]

    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.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2021
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.