Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in Numeric Pain Rating Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 12 and 17 years
- •Atraumatic lower extremity pain for >4 weeks
排除标准
- •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).
研究组 & 干预措施
Psychologically Informed Education
is arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with atraumatic lower extremity injuries.
干预措施: Psychologically Informed Education Video Series (Other)
Control Education
This arm will provide education of basic leg anatomy and will not address maladaptive psychological behaviors.
干预措施: Anatomy and biomedical education videos (Other)
结局指标
主要结局
Change in Numeric Pain Rating Scale
时间窗: Baseline, 1 month, 3 months, 6 months, 1 year
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 Lower Extremity Function Scale.
时间窗: Baseline, 1 month, 3 months, 6 months, 1 year
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 physical activity levels as measure by activity monitor
时间窗: Baseline, 1 month, 3 months, 6 months, 1 year
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.
次要结局
- Change in Kinesiophobia(Baseline, 1 month, 3 months, 6 months, 1 year)
- Change in Fear-Avoidance Beliefs(Baseline, 1 month, 3 months, 6 months, 1 year)
- Change in Pain Catastrophizing(Baseline, 1 month, 3 months, 6 months, 1 year)
- Change in Pain Self Efficacy Questionnaire(Baseline, 1 month, 3 months, 6 months, 1 year)
研究者
Mitchell Selhorst
Physical Therapist/Principal Investigator
Nationwide Children's Hospital