Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Scale
研究概览
简要总结
Invesigators plan to conduct a 12-week longitudinal cohort study of 30 subjects with calcaneal apophysitis. Subjects will be included if they are between 7-17 years-old, have experienced an insidious onset of heel pain with running or jumping activities, and have no underlying diagnosis predisposing heel pain and no other injury that limits their ability to run and jump. Parents of subjects will be invited to participate by completing questionnaires related to their perspective of their child's symptoms, physical activity level, quality of life, and their satisfaction with the treatment protocol. Subjects will be asked to attend 4 monthly sessions consisting of evaluation and treatment.
详细描述
Investigators will recruit 30 subjects between ages 7-17 with heel pain and also invite their parent/guardian to participate in this research study. Participants will be evaluated at baseline, 4-weeks, 8-weeks and 12-weeks. Data collections at each assessment visit will be identical except for the baseline visit. The baseline evaluation will consist of questionnaires related to past medical history in addition to all other procedures. All evaluations will include patient-reported outcome measures, clinical measures, and measurement of tendon structure, mechanical properties, and muscle-tendon function Treatment sessions will occur immediately following the evaluation sessions (4 total). During treatment sessions, participants will be provided with education, therapeutic exercise instruction, and discussion of their training diary and home exercise program. Treatment sessions will last 30-45 minutes. In addition to the 4 in-person treatment sessions, virtual visits will take place 2 weeks in between each in-person visits, (one virtual visit maximum every 4 weeks) as needed. Virtual visits will be no longer than 30 minutes to discuss patient needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insidious onset of heel pain with running or jumping activities lasting at least three weeks
- •Location of pain is focal at the calcaneus over the Achilles tendon attachment and/or the Achilles tendon
排除标准
- •Subjects having an underlying diagnosis predisposing to heel pain (spina bifida, osteogenesis imperfecta, Larsen syndrome, cerebral palsy)
- •History of calcaneal fracture or foot/ankle surgery in the past 6 months
- •Another injury that limits the ability to perform exercises on the injured leg
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Scale
时间窗: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
The PROMIS Pain Interference Scale assesses symptom severity and pain with daily activity. Raw scores range from 8-40, where lower scores indicate less pain interference.
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
时间窗: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
The VISA-A was specifically designed to assess symptom severity in individuals with Achilles tendinopathy and has demonstrated validity, reliability and responsiveness. Scores range from 0-100, where a higher score indicates less pain and symptoms with activity. This outcome measure has been used in previous trials with adolescents.
Compliance
时间窗: Average compliance rate for each group over first year of study recruitment
Compliance will be tracked using training diaries. The number of training diaries and prescribed exercise sessions completed, and days in adherence with activity modification guidelines will be recorded. Compliance rates will be reported as a percentage, relative to the participants duration of participation in the study.
Tendon Mechanical Properties
时间窗: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Subjects will be examined using continuous shear wave elastography (cSWE). This is a non-invasive technique that uses a low-amplitude vibration to mechanically perturbate the tendon. The resultant shear wave is imaged using ultrasound. The area of maximum tendon pathology will be identified using palpation and B mode ultrasound imaging. The distance from calcaneal insertion to this area will be measured to allow for identification of a comparable location on the asymptomatic side as well as to ensure the same area is assessed at each follow-up. The ultrasound probe for cSWE will be placed at this location and the actuator will be placed just proximal to the ultrasound probe.
Tendon Structure
时间窗: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Ultrasound images will be obtained using the LOGIQ e Ultrasound (GE Healthcare) system using a wide-band linear array probe (5.0-13.0 MHz). The subject will be prone lying with the hips and knees straight and the ankles hanging outside the treatment table. Three longitudinal images where the calcaneal insertion and as much of the tendon is visible will be saved. Three extended field of view images of the tendon between the insertion to the calcaneus and the start of the soleus muscle will be saved. Longitudinal and cross-sectional images will be taken at the area of tenderness to palpation on the injured side and at the same position on the contralateral side. These images will be used to evaluate tendon thickening, cross-sectional area, and the occurrence of hypoechoic areas.
Muscle-Tendon Function
时间窗: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Muscle-tendon function will be assessed by a functional test battery including a single-leg counter movement jump (CMJ), a single-leg drop CMJ, single-leg hopping, and the heel-rise endurance test. For jump tests, the jump height for three trials will be recorded using a light mat (MuscleLab®, Ergotest Innovations, Porsgrunn, Norway). The drop CMJ jump is performed on single leg by jumping from a 20cm high box, landing, and immediately jumping up for maximum height. Hopping is similar or jumping rope on one foot; two trials of 20 hops will be recorded using a light mat to calculate hop frequency, average height, and plyometric quotient (flight time / contact time). The heel-rise endurance test is a single-leg standing heel-rise test. The heel-rise test for endurance is performed on one leg at a time with the participant standing on a box with an incline of 10°. A metronome is used to maintain the frequency of 30 heel-rises per minute.
次要结局
- PROMIS Pediatric Physical Activity Short Form questionnaire(Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks)
- The Fear of Pain Questionnaire Child Report (FOBQC)(Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks)
- PROMIS Parent Proxy Pain Interference questionnaire(Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks)
- The Foot and Ankle Outcomes Score (FAOS)(Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks)
- The Global Rating of Change (GROC) scale(Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks)
- Ankle range of motion(Change over time with evaluations at baseline, 4-weeks, 8-weeks,10-weeks, and 12-weeks)
- PROMIS Pediatric Global Health questionnaire(Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks)
- PROMIS Parent Proxy Pain Intensity questionnaire(Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks)
- PROMIS Parent Proxy Global Health questionnaire(Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks)
- PROMIS Parent Proxy Physical Activity questionnaire(Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks)
- Fear of Pain Questionnaire Parent Report (FOBQP)(Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks)
研究者
Karin Silbernagel
Professor
University of Delaware