Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain

NCT ID: NCT04752501

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2022-08-10

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.

Conditions

Patellofemoral Pain Syndrome; Knee Pain Chronic; Patellofemoral Syndrome; Anterior Knee Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Psychologically Informed Video Series

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.

Group Type: EXPERIMENTAL

Psychologically Informed Education

Intervention Type: OTHER

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

Biomedical Education Video Series

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

Group Type: ACTIVE_COMPARATOR

Biomedical Education (Control)

Intervention Type: OTHER

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

Interventions

Psychologically Informed Education

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

Intervention Type: OTHER

Biomedical Education (Control)

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mitchell Selhorst

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitchell Selhorst, DPT, PHD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital Sports and Ortho PT East Broad

Columbus, Ohio, United States

Countries

United States

References

Grotle M, Garratt AM, Krogstad Jenssen H, Stuge B. Reliability and construct validity of self-report questionnaires for patients with pelvic girdle pain. Phys Ther. 2012 Jan;92(1):111-23. doi: 10.2522/ptj.20110076. Epub 2011 Oct 20.

Reference Type: BACKGROUND

PMID: 22016375 (View on PubMed)

Leventhal H, Phillips LA, Burns E. The Common-Sense Model of Self-Regulation (CSM): a dynamic framework for understanding illness self-management. J Behav Med. 2016 Dec;39(6):935-946. doi: 10.1007/s10865-016-9782-2. Epub 2016 Aug 11.

Reference Type: BACKGROUND

PMID: 27515801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28009822 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22321917 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21372203 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15839307 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15129407 (View on PubMed)

Selhorst M, Hoehn J, Schmitt L, Benedict J, Fernandez-Fernandez A. The Effect of a Psychologically Informed Video Series to Treat Adolescents With Patellofemoral Pain: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2023 Oct;53(10):634-642. doi: 10.2519/jospt.2023.12041.

Reference Type: DERIVED

PMID: 37706686 (View on PubMed)

Other Identifiers

IRB18-00724.2

Identifier Type: -

Identifier Source: org_study_id