Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

The Effect of Psychologically Informed Education in Adolescents With Anterior Knee Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897907
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Mitchell Selhorst, Nationwide Children's Hospital

Brief Summary:
This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with anterior knee pain. A set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participant/parents. Participants will then complete clinical tests of physical performance, numeric pain rating scale, and a self-report questionnaire of functional ability. Participants will then be randomized into one of two psychosocial intervention groups (psychologically informed education group and a control group). After participants receive their assigned education intervention, the clinical tests of pain and self-reported functional ability will be readministered. Participants with anterior knee pain will then complete follow-up surveys of their psychosocial beliefs, pain and self-reported functional ability through REDcap at immediately post-intervention, 2 weeks, 6 weeks, and 3 months.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Anterior Knee Pain Syndrome Other: Psychologically Informed Education Video Other: Anatomy Education Video Not Applicable

Detailed Description:

This study will be a prospective randomized controlled trial design. Participants will complete the randomized intervention immediately after completing baseline testing. Post-intervention testing will also be completed immediately after the randomized intervention. A follow-up REDcap survey will be sent by email to assess function and pain at 2 weeks, 6 weeks and 3 months.

Intervention Psychologically Informed Education Group Psychologically Informed Education Medium There are many ways to provide patient education, but the investigators believe that adolescents will respond well to video education on a tablet. Adolescents are extremely comfortable with this technology, and the video will allow for standardized education among all participants.

Development of Psychologically Informed Education for adolescents with AKP Recommended adult pain science education will be modified using published recommendations for the adolescent population and tailored to anterior knee pain.(Robins, Perron, Heathcote, & Simons, 2016) The education session will teach participants how the body processes nociception and experiences pain, and pain does not mean tissues are being damaged. Additionally the psychologically informed education video 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).(Leventhal, Phillips, & Burns, 2016) Control Group Participants in the control education group will watch a video on the iPad equal in length to the psychologically informed education video. The control video will discuss basic anatomy of the knee and provide no psychosocial education or positive reinforcement about their condition.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: This research study is a double-blinded randomized controlled trial. The participants will not be made aware which education video they watch is the control and which is the intervention. The study staff will be blinded to group allocation until after measurements are completed.
Primary Purpose: Treatment
Official Title: The Psychosocial Impact on Pain and Function in Adolescents With Anterior Knee Pain
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Arm Intervention/treatment
Experimental: Psychologically Informed Education
This arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with knee pain
Other: Psychologically Informed Education Video
The education session 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)

Placebo Comparator: Control Education
This arm will provide education of basic knee anatomy and will not address maladaptive psychological behaviors.
Other: Anatomy Education Video
Participants in the control education group will watch a video on the iPad equal in length to the psychologically informed education video. The control video will discuss basic anatomy of the knee and provide no psychosocial education or positive reinforcement about their condition.




Primary Outcome Measures :
  1. Change in Anterior Knee Pain Scale [ Time Frame: Time Frame: Baseline, Immediately post-interventions, 2 weeks (12-16 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 10 points represent the minimal clinical difference (Crossley, 2004).


Secondary Outcome Measures :
  1. Change in Numeric Pain Rating Scale [ Time Frame: Time Frame: Baseline, Immediately post-interventions, 2 weeks (12-16 days post-evaluation), 6 weeks (39-46 days post-evaluation), and 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  1. Prior history of patellar dislocation.
  2. Suspicion of other diagnosis of the knee by evaluating physical therapist or principal investigator.
  3. Other concomitant injury of the leg.
  4. Prior history of knee surgery.
  5. 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).
  6. Numbness and tingling in any lumbar dermatome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897907


Contacts
Layout table for location contacts
Contact: Mitchell Selhorst, DPT 614-355-9764 Mitchell.Selhorst@Nationwidechildrens.org

Locations
Layout table for location information
United States, Ohio
Nationwide Children's Hospital Sports and Ortho Physical Therapy Recruiting
Columbus, Ohio, United States, 43215
Contact: Mitchell Selhorst, DPT    614-355-9764    Mitchell.Selhorst@Nationwidechildrens.org   
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Mitchell Selhorst, DPT Nationwide Children's Hospital

Publications:
Layout table for additonal information
Responsible Party: Mitchell Selhorst, Physical Therapist/Principle Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03897907    
Other Study ID Numbers: IRB18-00724
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Patellofemoral Pain Syndrome
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases