Clinical trial NCT04752501: Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain
Official title: Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Knee Pain Chronic
Patellofemoral Syndrome
Anterior Knee Pain Syndrome
Keywords: Knee
Adolescent
Psychologically-informed
Anterior Knee Pain
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Anterior Knee Pain Scale
timeFrame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
Secondary outcomes:
measure: Change in Numeric Pain Rating Scale
timeFrame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
measure: Change in self-reported physical activity level.
timeFrame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
measure: Change in Fear-Avoidance Beliefs
timeFrame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
measure: Change in Kinesiophobia
timeFrame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
measure: Change in Pain Catastrophizing
timeFrame: Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital Sports and Ortho PT East Broad
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Mitchell Selhorst, DPT, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Robins H, Perron V, Heathcote LC, Simons LE. Pain Neuroscience Education: State of the Art and Application in Pediatrics. Children (Basel). 2016 Dec 21;3(4):43. doi: 10.3390/children3040043.
citation: Vlaeyen JWS, Linton SJ. Fear-avoidance model of chronic musculoskeletal pain: 12 years on. Pain. 2012 Jun;153(6):1144-1147. doi: 10.1016/j.pain.2011.12.009. Epub 2012 Feb 8. No abstract available.
citation: Wang YC, Hart DL, Stratford PW, Mioduski JE. Baseline dependency of minimal clinically important improvement. Phys Ther. 2011 May;91(5):675-88. doi: 10.2522/ptj.20100229. Epub 2011 Mar 3.
citation: Watson CJ, Propps M, Ratner J, Zeigler DL, Horton P, Smith SS. Reliability and responsiveness of the lower extremity functional scale and the anterior knee pain scale in patients with anterior knee pain. J Orthop Sports Phys Ther. 2005 Mar;35(3):136-46. doi: 10.2519/jospt.2005.35.3.136.
citation: Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch Phys Med Rehabil. 2004 May;85(5):815-22. doi: 10.1016/s0003-9993(03)00613-0.