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Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries

Primary Purpose

Leg Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychologically Informed Education Video Series
Anatomy and biomedical education videos
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Injury focused on measuring Adolescent, Atraumatic, Education, Patellofemoral, Tendinopathy, Apophysitis, Overuse

Eligibility Criteria

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

Inclusion criteria Age between 12 and 17 years Atraumatic lower extremity pain for >4 weeks Exclusion criteria Suspicion or evidence of complete tendon or ligamentous tear. Current fracture in the lower extremity. Prior history of surgery in the lower extremity. Neurologic or developmental disorder, which alters lower extremity function. Numbness and tingling in any lumbar dermatome. 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).

Sites / Locations

  • Nationwide Children's Hospital Sports and Ortho Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Psychologically Informed Education

Control Education

Arm Description

is arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with atraumatic lower extremity injuries.

This arm will provide education of basic leg anatomy and will not address maladaptive psychological behaviors.

Outcomes

Primary Outcome Measures

Change in Lower Extremity Function Scale.
The lower extremity function scale is a 20-item self-report questionnaire used to evaluate functional ability during everyday tasks (0-80). Each item is scored on a 0-4 point scale with higher scores representing greater functional ability. The lower extremity function scale has validity in the adolescent population and has a minimal clinical important difference of 9 points.
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 physical activity levels as measure by activity monitor
Physical activity levels will be assessed with a wearable activity monitor: Total energy expenditure will be assessed using the Fitbit Inspire 3(TM) with Heart Rate Monitoring over a seven-day period. The Fitbit Inspire 3 (TM) is a wrist-worn activity monitor that demonstrates acceptable validity and reliability for assessing total energy expenditure. Higher levels of total energy expenditure levels represent higher levels of physical activity.

Secondary Outcome Measures

Change in Fear-Avoidance Beliefs
Fear avoidance beliefs as measured by the Fear Avoidance Beliefs Questionnaire-Physical Activity Subscale. The Fear Avoidance Beliefs Questionnaire-Physical Activity Subscale is a 4-item self-report questionnaire (0-24). Each item is scored 0-6 with higher scores representing higher levels of fear-avoidance beliefs.
Change in Kinesiophobia
Change in kinesiophobia beliefs as measure by the Tampa Scale for Kinesiophobia-11. The Tampa Scale of Kinesiophobia-11 is an 11 item self-report questionnaire (11-44 scale). Ratings range from 1 (strongly disagree) to 4 (strongly agree). Higher scores represent higher levels of kinesiophobia.
Change in Pain Catastrophizing
Change in pain catastrophizing as measured by the pain catastrophizing scale-child version. The Pain Catastrophizing Scale-child is a 13-item self-report measure (0-52). Each item is rated on a 5-point scale, ranging from 0 (not at all) to 4 (all the time). With higher scores representing higher levels of pain catastrophizing
Change in Pain Self Efficacy Questionnaire
The Pain Self Efficacy Questionnaire is a 10-item scale which assesses confidence in functioning despite pain. Each item is scored 0-6 with higher scores representing higher levels of pain self-efficacy (0-60). The PSEQ was originally designed for adults but has been found valid and reliable for adolescents

Full Information

First Posted
January 18, 2023
Last Updated
January 30, 2023
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05701618
Brief Title
Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries
Official Title
Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
January 23, 2025 (Anticipated)
Study Completion Date
January 23, 2025 (Anticipated)

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 leg pain. A set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participants. Participants will then complete self-report questionnaires assessing pain, quality of life and functional ability followed by an assessment of physical activity levels assessed with a wearable activity monitor;. Participants will then be randomized into one of two intervention groups (psychologically-informed video education group and a control group). After participants receive their assigned educational intervention, the self-report questionnaires will be re-administered. Participants with leg pain pain will then complete follow-up assessment of their psychological beliefs, pain, quality of life, physical activity levels, and self-reported functional ability through REDcap at 1 week, 4 weeks, 3 months, 6 months, and 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Injury
Keywords
Adolescent, Atraumatic, Education, Patellofemoral, Tendinopathy, Apophysitis, Overuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychologically Informed Education
Arm Type
Experimental
Arm Description
is arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with atraumatic lower extremity injuries.
Arm Title
Control Education
Arm Type
Placebo Comparator
Arm Description
This arm will provide education of basic leg anatomy and will not address maladaptive psychological behaviors.
Intervention Type
Other
Intervention Name(s)
Psychologically Informed Education Video Series
Intervention Description
A short three video series (5-8.5 minutes each) provides psychologically-informed education at an age-appropriate level to address kinesiophobia, pain catastrophizing, and fear-avoidance beliefs.30 Participants will view the three-part education video series on an iPad at their first visit (video 1), one week (video 2), and three weeks (video 3).
Intervention Type
Other
Intervention Name(s)
Anatomy and biomedical education videos
Intervention Description
Participants in the control group will watch three videos equal in length to the psychologically-informed videos. The control videos will discuss anatomy of the lower extremity, basic instruction in proper lower extremity biomechanics, and simple lower extremity exercises. The control videos will provide no psychologically-informed education or positive reinforcement about the condition.
Primary Outcome Measure Information:
Title
Change in Lower Extremity Function Scale.
Description
The lower extremity function scale is a 20-item self-report questionnaire used to evaluate functional ability during everyday tasks (0-80). Each item is scored on a 0-4 point scale with higher scores representing greater functional ability. The lower extremity function scale has validity in the adolescent population and has a minimal clinical important difference of 9 points.
Time Frame
Baseline, 1 month, 3 months, 6 months, 1 year
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 month, 3 months, 6 months, 1 year
Title
Change in physical activity levels as measure by activity monitor
Description
Physical activity levels will be assessed with a wearable activity monitor: Total energy expenditure will be assessed using the Fitbit Inspire 3(TM) with Heart Rate Monitoring over a seven-day period. The Fitbit Inspire 3 (TM) is a wrist-worn activity monitor that demonstrates acceptable validity and reliability for assessing total energy expenditure. Higher levels of total energy expenditure levels represent higher levels of physical activity.
Time Frame
Baseline, 1 month, 3 months, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Change in Fear-Avoidance Beliefs
Description
Fear avoidance beliefs as measured by the Fear Avoidance Beliefs Questionnaire-Physical Activity Subscale. The Fear Avoidance Beliefs Questionnaire-Physical Activity Subscale is a 4-item self-report questionnaire (0-24). Each item is scored 0-6 with higher scores representing higher levels of fear-avoidance beliefs.
Time Frame
Baseline, 1 month, 3 months, 6 months, 1 year
Title
Change in Kinesiophobia
Description
Change in kinesiophobia beliefs as measure by the Tampa Scale for Kinesiophobia-11. The Tampa Scale of Kinesiophobia-11 is an 11 item self-report questionnaire (11-44 scale). Ratings range from 1 (strongly disagree) to 4 (strongly agree). Higher scores represent higher levels of kinesiophobia.
Time Frame
Baseline, 1 month, 3 months, 6 months, 1 year
Title
Change in Pain Catastrophizing
Description
Change in pain catastrophizing as measured by the pain catastrophizing scale-child version. The Pain Catastrophizing Scale-child is a 13-item self-report measure (0-52). Each item is rated on a 5-point scale, ranging from 0 (not at all) to 4 (all the time). With higher scores representing higher levels of pain catastrophizing
Time Frame
Baseline, 1 month, 3 months, 6 months, 1 year
Title
Change in Pain Self Efficacy Questionnaire
Description
The Pain Self Efficacy Questionnaire is a 10-item scale which assesses confidence in functioning despite pain. Each item is scored 0-6 with higher scores representing higher levels of pain self-efficacy (0-60). The PSEQ was originally designed for adults but has been found valid and reliable for adolescents
Time Frame
Baseline, 1 month, 3 months, 6 months, 1 year

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 Age between 12 and 17 years Atraumatic lower extremity pain for >4 weeks Exclusion criteria Suspicion or evidence of complete tendon or ligamentous tear. Current fracture in the lower extremity. Prior history of surgery in the lower extremity. Neurologic or developmental disorder, which alters lower extremity function. Numbness and tingling in any lumbar dermatome. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitchell Selhorst, DPT, PhD
Phone
6143559764
Email
Mitchell.Selhorst@Nationwidechildrens.org
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 Physical Therapy
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Selhorst, DPT
Phone
614-355-9764
Email
Mitchell.Selhorst@Nationwidechildrens.org

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
33449504
Citation
Holden S, Kasza J, Winters M, van Middelkoop M, Rathleff MS; Adolescent Knee Health Group. Prognostic factors for adolescent knee pain: an individual participant data meta-analysis of 1281 patients. Pain. 2021 Jun 1;162(6):1597-1607. doi: 10.1097/j.pain.0000000000002184.
Results Reference
background
PubMed Identifier
31704460
Citation
Selhorst M, Hoehn J, Degenhart T, Schmitt L, Fernandez-Fernandez A. Psychologically-informed video reduces maladaptive beliefs in adolescents with patellofemoral pain. Phys Ther Sport. 2020 Jan;41:23-28. doi: 10.1016/j.ptsp.2019.10.009. Epub 2019 Oct 31.
Results Reference
background
PubMed Identifier
32223042
Citation
Maclachlan LR, Collins NJ, Hodges PW, Vicenzino B. Psychological and pain profiles in persons with patellofemoral pain as the primary symptom. Eur J Pain. 2020 Jul;24(6):1182-1196. doi: 10.1002/ejp.1563. Epub 2020 Apr 12.
Results Reference
background
PubMed Identifier
33490842
Citation
Coronado RA, Brintz CE, McKernan LC, Master H, Motzny N, Silva FM, Goyal PM, Wegener ST, Archer KR. Psychologically informed physical therapy for musculoskeletal pain: current approaches, implications, and future directions from recent randomized trials. Pain Rep. 2020 Sep 23;5(5):e847. doi: 10.1097/PR9.0000000000000847. eCollection 2020 Sep-Oct.
Results Reference
background
PubMed Identifier
31910939
Citation
Yang X, Jago R, Zhang Q, Wang YY, Zhang J, Zhao WH. Validity and Reliability of the Wristband Activity Monitor in Free-living Children Aged 10-17 Years. Biomed Environ Sci. 2019 Nov;32(11):812-822. doi: 10.3967/bes2019.103.
Results Reference
result
PubMed Identifier
30802913
Citation
Stahlschmidt L, Hubner-Mohler B, Dogan M, Wager J. Pain Self-Efficacy Measures for Children and Adolescents: A Systematic Review. J Pediatr Psychol. 2019 Jun 1;44(5):530-541. doi: 10.1093/jpepsy/jsz002.
Results Reference
result

Learn more about this trial

Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries

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