Exercise Therapy and Physical Activity Modification for Patients With Sever's Disease (SDX)
Exercise Therapy and Physical Activity Modification for Patients With Sever's Disease: A Randomized Controlled Trial
Sever's disease is an overuse injury to the calcaneal growth plate caused by repetitive traction stress from the Achilles tendon in youth. Limited evidence exists to guide effective treatment for Sever's disease and disrupt short- and long-term pain and disability. Exercise therapy has the strongest evidence to promote tissue healing and is supported for other growth plate injuries. This study aims to determine if a comprehensive exercise therapy and activity modification intervention produces a clinically meaningful improvement in (Aim 1) pain and lower extremity function, (Aim 2) muscle and tendon structure, and (Aim 3) physical activity, compared to a non-exercise palliative approach for patients with Sever's disease. Differences between groups after completing 12 weeks of intervention.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Sever's disease (calcaneal apophysitis) is a debilitating overuse injury to the calcaneal apophysis (growth plate) caused by repetitive traction stress on the growth plate. The condition occurs in 3.7 per 1,000 young patients, most commonly between ages 8-15 years old. Patients with Sever's disease experience months of heel pain with running and jumping activities, reduced quality of life, and struggle to participate in social and sports activities. Symptoms can progress from self-limiting to complete loss of function and may persist into adulthood, leading to early retirement from sport. Therefore, effective rehabilitation is essential to curb the substantial negative implications on physiological and psychological health that may continue into adulthood and contribute to healthcare utilization and global physical inactivity trends.
There is a lack of high-quality evidence to guide intervention for Sever's disease. Expert opinion maintains that pain and dysfunction resolve spontaneously when patients reach skeletal maturity. As a result, palliative interventions consisting of activity avoidance or cessation are often prescribed for symptom relief. At the tissue level, these passive strategies risk the healthy maturation of load-bearing tissues through physical activity (PA) in the most critical years of growth.Recent evidence of altered Achilles tendon structure in patients with Sever's disease suggests this condition may have lifelong implications. This underscores an immediate need to develop an evidence-based treatment strategy that supports tissue remodeling during this critical time of growth and encourages a physically active lifestyle in adulthood. Exercise therapy promotes tissue healing and is effective for patients with Achilles tendinopathy and other apophyseal injuries. Our pilot study determined that this treatment approach is feasible and safe for patients with Sever's disease and preliminary results support conducting a larger clinical trial to determine efficacy to improve clinical outcomes. We propose to conduct a 12-week randomized controlled trial to evaluate the effectiveness of a comprehensive tendon-loading protocol compared to a palliative control approach for treating Sever's disease. The experimental group (EXP) will receive a comprehensive intervention including a tendon-loading protocol and education on daily pain monitoring to allow continued sports participation within a tolerable pain range. The control group (CTL) will be instructed to participate in activities of daily life and sports as tolerated. Both groups will be provided gel heel cups and an activity diary. Both groups will be asked to don a wearable ActivPAL activity monitor for seven consecutive days after data collection at baseline, 6-, and 12- weeks. Our specific aims are: (1) To determine if the comprehensive intervention produces clinically meaningful improvement in symptom severity, lower extremity function, and psychosocial factors compared to palliative care over 12 weeks. (2) Evaluate changes in triceps surae and Achilles tendon morphology and mechanical properties over time. (3) Explore weekly PA volume and intensity at time of diagnosis and changes during intervention.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Shawn L Hanlon, PhD
- Número de telefone: 657-278-5869
- E-mail: shanlon@fullerton.edu
Locais de estudo
-
-
California
-
Fullerton, California, Estados Unidos, 92831
- Recrutamento
- Kinesiology and Health Sciences Building
-
Contato:
- Shawn L Hanlon, PhD
- Número de telefone: 657-278-3316
- E-mail: shanlon@fullerton.edu
-
Contato:
- E-mail: shawnhanlon90@gmail.com
-
Investigador principal:
- Shawn L Hanlon, PhD
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Insidious onset of heel pain over several weeks
- Pain on palpation of the calcaneus or Achilles tendon
- Complaint of heel pain with running or jumping activities.
Exclusion Criteria:
- Any underlying condition predisposing heel pain (i.e., spina bifida, osteogenesis imperfecta, Larsen syndrome, cerebral palsy)
- Any other injury that limits their ability to run or jump.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: Experimental Group
The experimental group will receive supervised progressive tendon-loading exercise therapy, pain-guided activity modification education, and feedback on daily activity. Both groups will receive gel heel cushion inserts for footwear. |
Therapeutic Achilles-tendon loading exercise; Activity modification using a Pain Monitoring Model |
|
Comparador Ativo: Control Group
The control group will not receive progressive tendon-loading exercise. The control group will receive the same education as the experimental group, except the control group will be asked to participate in activities as tolerated and rest as needed. The control group will be asked to record the same activity diary as the experimental group, but will not receive feedback on their daily activity. Both groups will receive gel heel cushion inserts for footwear. |
Conventional Clinician advice for pediatric overuse injury management. |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Self-reported Achilles tendon or heel pain and Symptoms with Activity
Prazo: Baseline, 6 weeks, and 12 weeks after randomization.
|
The Victorian Institute of Sport Assessment-Achilles (VISA-A) will be used. Survey completed via participant interview at baseline. Survey completed online by participants for follow-up visits. |
Baseline, 6 weeks, and 12 weeks after randomization.
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Single-leg Countermovement Jump Height
Prazo: Baseline, 6 weeks, and 12 weeks after randomization.
|
Participants will be instructed to keep their arms behind their back and jump as high as possible on a flat surface. Jump height will be measured in cm via the MuscleLab contact grid. |
Baseline, 6 weeks, and 12 weeks after randomization.
|
|
Single-leg Drop Countermovement Jump Height
Prazo: Baseline, 6 weeks, and 12 weeks after randomization.
|
The drop CMJ is performed by standing on the edge of a 20cm box, then stepping off to land and immediately rebounding as high as possible. Jump height will be measured in cm via the MuscleLab contact grid. |
Baseline, 6 weeks, and 12 weeks after randomization.
|
|
Total Heel-rise Work
Prazo: Baseline, 6 weeks, and 12 weeks after randomization.
|
The heel-rise endurance test is performed barefoot while standing on a single leg on a slant board fixed at 10 degrees of dorsiflexion. Participants will be instructed to perform as many heel-rises as possible while maintaining a straight knee and a slight forward lean, lifting the heel as high as possible, to a metronome set at 60 beats/min (30 heel-rises/min). Participants will place only two fingers from each hand on the wall to maintain balance. The test will conclude when the participant is unable maintain the test cadence, elect to stop due to fatigue or pain, or perform consistent repetitions with compensation. A linear encoder will be taped to the posterior calcaneus, which records linear displacement (heel-rise height, cm) for each repetition. Total heel-rise work will be calculated in Joules by summing the displacement for each repetition, multiplied by body mass and the force of gravity. |
Baseline, 6 weeks, and 12 weeks after randomization.
|
|
Achilles Tendon Cross-sectional Area
Prazo: Baseline, 6 weeks, and 12 weeks after randomization.
|
B-mode ultrasound imaging (GE P9 Xdclear R4.5, GE Healthcare) will be used to assess the Achilles tendon cross-sectional area in short-axis images. CSA will be measured at the thickest portion of the free Achilles tendon. |
Baseline, 6 weeks, and 12 weeks after randomization.
|
|
Shear Wave Velocity
Prazo: Baseline, 6 weeks, and 12 weeks after randomization.
|
Shear wave velocity (SWV) will be measured using Ultrasound Shear Wave Elastography. SWV is a measurement of resistance to deformation (stiffness) in tendon. Participants will be positioned prone, with legs past the mid-shank suspended over the edge of the exam table and feet resting against a custom wall-mounted slant board to fix the ankles at 15 degrees of dorsiflexion. The region of interest will be between the anterior-posterior borders of the Achilles tendon visualized on b-mode ultrasound imaging in longitudinal axis and centered over the thickest portion of the free Achilles tendon. This distance will be documented from the cephalad border of the Achilles tendon osteotendinous junction (calcaneal notch). In cases of uniform thickness, the ROI will be standardized to 2cm proximal to the calcaneal notch. The average of three trials will be analyzed. |
Baseline, 6 weeks, and 12 weeks after randomization.
|
|
Achilles Tendon Echogenicity
Prazo: Baseline, 6 weeks, and 12 weeks after randomization.
|
The percentage of white to greyscale pixels (range 0-255) is calculated within a region of interest using the LAX Achilles tendon thickness images. |
Baseline, 6 weeks, and 12 weeks after randomization.
|
|
Daily Step Count
Prazo: 2 weeks before randomization, Baseline, 6 weeks, and 12 weeks after randomization.
|
Number of steps taken during waking hours measured using a wearable accelerometer- and inclinometer-based sensor (ActivPAL). Participants will wear the device continuously for 7 days at each study time point. |
2 weeks before randomization, Baseline, 6 weeks, and 12 weeks after randomization.
|
|
Daily Activity Minutes
Prazo: 2 weeks before randomization, Baseline, 6 weeks, and 12 weeks after randomization.
|
Daily minutes/day spent sitting, standing, stepping, and being sedentary will be averaged for each participant across all valid days using a wearable accelerometer- and inclinometer-based sensor (ActivPAL4+). Participants will wear the device continuously for 7 days at each study time point. Additionally, daily minutes at a moderate-to-vigorous activity stepping cadence will be analyzed. |
2 weeks before randomization, Baseline, 6 weeks, and 12 weeks after randomization.
|
|
Foot and Ankle Outcome Score
Prazo: Baseline, 6 weeks, and 12 weeks after randomization.
|
Assesses foot and ankle-related symptoms, function, participation, and quality of life |
Baseline, 6 weeks, and 12 weeks after randomization.
|
|
Tampa Scale For Kinesiophobia
Prazo: Baseline, 6 weeks, and 12 weeks after randomization.
|
Baseline, 6 weeks, and 12 weeks after randomization.
|
|
|
Oxford Foot And Ankle Questionnaire Child Version
Prazo: Baseline, 6 weeks, and 12 weeks after randomization.
|
Baseline, 6 weeks, and 12 weeks after randomization.
|
|
|
Global Rating of Change
Prazo: 6 weeks, and 12 weeks after randomization.
|
"Please rate the overall change in your condition from the time that you began the study until now." Measured on an 11-point likert scale, where -5 is "A very great deal worse", 0 is "No change", and +5 is "A very great deal better". |
6 weeks, and 12 weeks after randomization.
|
|
Global Rating of Function
Prazo: 6 weeks, and 12 weeks after randomization.
|
"On a scale of 0 - 100, please rate the use/function of your injured body part?" 0 is No Function/Unable to Use Injured Body Part, and 100 is ull Function/ Full use of Injured Body Part. |
6 weeks, and 12 weeks after randomization.
|
|
Satisfaction
Prazo: 6 weeks, and 12 weeks after randomization.
|
"How satisfied are you with the current use/function of your injured body part?" 0-10 scale, where 0 is "Not satisfied" and 10 is "Very satisfied". |
6 weeks, and 12 weeks after randomization.
|
|
Patient Acceptable Symptom Scale
Prazo: 6 weeks, and 12 weeks after randomization.
|
"Considering all the activities and sports you do each day, how much you hurt, and what you can do with and without pain, are you satisfied with your current condition?" Yes/No answer. |
6 weeks, and 12 weeks after randomization.
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Shawn L Hanlon, PhD, California State University, Fullerton
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- HSR-25-26-54
- #25NIP02 (Número de outro subsídio/financiamento: National Athletic Trainers' Association Research and Education Foundation)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Data will be shared upon reasonable request as decided by the Principal Investigator.
Prazo de Compartilhamento de IPD
At the conclusion of data collection (est. July 31, 2028).
Critérios de acesso de compartilhamento IPD
Data will be made publicly available no later than six months after the final publication.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .