Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752501
• Other study ID #: IRB18-00724.2
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: August 10, 2022

Study information

• Verified date: March 2023
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 10, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Knee Pain Syndrome
• Knee Pain Chronic
• Patellofemoral Pain Syndrome
• Patellofemoral Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Psychologically Informed Education
This arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with knee pain
• 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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital Sports and Ortho PT East Broad	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]