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Clinical Trials/NCT04752501
NCT04752501
Completed
Not Applicable

Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain

Nationwide Children's Hospital1 site in 1 country68 target enrollmentMarch 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellofemoral Pain Syndrome
Sponsor
Nationwide Children's Hospital
Enrollment
68
Locations
1
Primary Endpoint
Change in Anterior Knee Pain Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 8, 2021
End Date
August 10, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mitchell Selhorst

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Change in Numeric Pain Rating Scale(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.(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(Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months])
  • Change in 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(Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months])

Study Sites (1)

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