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Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain

Primary Purpose

Patellofemoral Pain Syndrome, Knee Pain Chronic, Patellofemoral Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychologically Informed Education
Biomedical Education (Control)
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Knee, Adolescent, Psychologically-informed, Anterior Knee Pain

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nationwide Children's Hospital Sports and Ortho PT East Broad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psychologically Informed Video Series

Biomedical Education Video Series

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
February 9, 2021
Last Updated
March 30, 2023
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04752501
Brief Title
Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain
Official Title
Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, Knee Pain Chronic, Patellofemoral Syndrome, Anterior Knee Pain Syndrome
Keywords
Knee, Adolescent, Psychologically-informed, Anterior Knee Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This research study is a blinded randomized controlled trial. The participants will not be made aware which education video series they watch is the control and which is the intervention. The study staff will be blinded to group allocation until after measurements are completed.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychologically Informed Video Series
Arm Type
Experimental
Arm Description
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.
Arm Title
Biomedical Education Video Series
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Psychologically Informed Education
Intervention Description
This arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with knee pain
Intervention Type
Other
Intervention Name(s)
Biomedical Education (Control)
Intervention Description
This arm will provide education of basic knee anatomy, lower extremity mechanics, and simple exercises and will not address maladaptive psychological behaviors
Primary Outcome Measure Information:
Title
Change in Anterior Knee Pain Scale
Description
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).
Time Frame
Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
Secondary Outcome Measure Information:
Title
Change in Numeric Pain Rating Scale
Description
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.
Time Frame
Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
Title
Change in self-reported physical activity level.
Description
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.
Time Frame
Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
Title
Change in Fear-Avoidance Beliefs
Description
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.
Time Frame
Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
Title
Change in Kinesiophobia
Description
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.
Time Frame
Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]
Title
Change in Pain Catastrophizing
Description
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.
Time Frame
Baseline, 1 week, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Selhorst, DPT, PHD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital Sports and Ortho PT East Broad
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Access Criteria
As a part of this research, it will be necessary to collect identifying information. Even though the final dataset will be stripped of identifiers prior to release for sharing, the patient sample is composed of minors who are a protected patient population Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Aggregate data including sample means, standard deviations, frequencies and significance values will be shared through peer-reviewed publications and conference abstracts. Email requests for data-sharing agreements to Mitchell.Selhorst@Nationwidechildrens.org
Citations:
PubMed Identifier
22016375
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.
Results Reference
background
PubMed Identifier
27515801
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.
Results Reference
background
PubMed Identifier
28009822
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.
Results Reference
background
PubMed Identifier
22321917
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.
Results Reference
background
PubMed Identifier
21372203
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.
Results Reference
background
PubMed Identifier
15839307
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.
Results Reference
background
PubMed Identifier
15129407
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.
Results Reference
background

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Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain

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