Clinical trial NCT05701618: 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
Overall status: RECRUITING
Phase: NA
Conditions: Leg Injury
Keywords: Adolescent
Atraumatic
Education
Patellofemoral
Tendinopathy
Apophysitis
Overuse
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 86
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria

1. Age between 12 and 17 years
2. Atraumatic lower extremity pain for \>4 weeks

Exclusion criteria

1. Suspicion or evidence of complete tendon or ligamentous tear.
2. Current fracture in the lower extremity.
3. Prior history of surgery in the lower extremity.
4. Neurologic or developmental disorder, which alters lower extremity function.
5. Numbness and tingling in any lumbar dermatome.
6. 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).

Primary outcomes:
measure: Change in Lower Extremity Function Scale.
timeFrame: Baseline, 1 month, 3 months, 6 months, 1 year
measure: Change in Numeric Pain Rating Scale
timeFrame: Baseline, 1 month, 3 months, 6 months, 1 year
measure: Change in physical activity levels as measure by activity monitor
timeFrame: Baseline, 1 month, 3 months, 6 months, 1 year
Secondary outcomes:
measure: Change in Fear-Avoidance Beliefs
timeFrame: Baseline, 1 month, 3 months, 6 months, 1 year
measure: Change in Kinesiophobia
timeFrame: Baseline, 1 month, 3 months, 6 months, 1 year
measure: Change in Pain Catastrophizing
timeFrame: Baseline, 1 month, 3 months, 6 months, 1 year
measure: Change in Pain Self Efficacy Questionnaire
timeFrame: Baseline, 1 month, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital Sports and Ortho Physical Therapy
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Mitchell Selhorst, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.