- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07932743
Calf Strengthening With or Without Hip Strengthening for Athletes With Recurring Shin Splints
Effects of Progressive Loading of Soleus With and Without Hip Strengthening on Pain, Strength, Dynamic Balance and Return to Sports in Athletes With Recurrent Medial Tibial Stress Syndrome
The goal of this clinical trial is to learn whether adding hip strengthening exercises to a calf strengthening program works better than the calf program alone for athletes aged 18 to 40 who keep getting shin splints (pain along the inner edge of the shin bone during or after running). The study will find out which program better reduces shin pain, increases calf and hip muscle strength, improves balance while reaching on one leg, and helps athletes return to their sport without pain. Researchers will compare a progressive calf (soleus) strengthening program alone with the same calf program plus hip strengthening exercises. Participants will receive one of the two programs 3 times a week for 8 weeks (24 sessions), along with advice on managing training load, stretching, balance exercises and a gradual return-to-running plan. They will complete tests of pain, muscle strength, balance, daily function and return to sport at the start, at week 4 and at week 8.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Punjab Province
-
Lahore, Punjab Province, Paquistão, 54000
- University of Management & Technology
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
-
Athletes aged 18-40 years participating in competitive or recreational sports.
- Both male and female athletes.
- Diagnosis of recurrent medial tibial stress syndrome according to the Yates and White criteria, characterized by exercise-induced pain along the posteromedial border of the tibia with tenderness extending over 5 cm or more.
- Pain intensity ranging from 4 to 6 on the Numeric Pain Rating Scale (NPRS).
- Pain occurring during running or within 24 hours following running activity.
- History of two or more symptomatic episodes of MTSS within the previous 12 months.
Exclusion Criteria:
-
● Confirmed chronic exertional compartment syndrome.
- History of lower-limb surgery within the previous six months.
- Clinically confirmed tibial stress fracture or any other bony pathology.
- Acute lower-limb injury (sprain, strain, or fracture) within the previous six weeks.
- Use of systemic corticosteroids, bisphosphonates, or non-steroidal anti-inflammatory drugs (NSAIDs) for more than 14 consecutive days within 30 days before enrolment.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Progressive Loading of Soleus (PLS)
Progressive soleus loading program plus basic rehabilitation, 3 supervised sessions per week for 8 weeks (24 sessions). |
Structured progressive soleus loading exercises to improve plantar-flexor strength, muscular endurance and tibial load tolerance. Load and intensity are progressed gradually according to each participant's tolerance and clinical response. |
|
Experimental: Progressive Loading of Soleus Combined with Hip Strengthening
The same progressive soleus loading program and basic rehabilitation as Arm 1, plus hip strengthening, 3 supervised sessions per week for 8 weeks (24 sessions). |
Strengthening exercises for the hip abductors, extensors and external rotators, performed for approximately 15 to 20 minutes per session, with individualized progression. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Intensity (Numeric Pain Rating Scale)
Prazo: Baseline (Week 0), Week 4 and Week 8.
|
An 11-point self-reported scale from 0 (no pain) to 10 (worst imaginable pain), rating average pain during running or sports activities. Lower scores indicate less pain. |
Baseline (Week 0), Week 4 and Week 8.
|
|
Muscle Strength (Handheld Dynamometer)
Prazo: Baseline (Week 0), Week 4 and Week 8.
|
Isometric strength of the plantar-flexor and hip muscles, measured with a handheld dynamometer. Higher values indicate greater strength. |
Baseline (Week 0), Week 4 and Week 8.
|
|
Dynamic Balance (Y-Balance Test)
Prazo: Baseline (Week 0), Week 4 and Week 8.
|
Single-leg reach in the anterior, posteromedial and posterolateral directions, normalized to limb length and reported as a composite score (% of limb length). Higher scores indicate better dynamic balance. |
Baseline (Week 0), Week 4 and Week 8.
|
|
Pain-Free Return to Sport
Prazo: Baseline (Week 0), Week 4 and Week 8.
|
Whether the participant completes the graded return-to-running program and resumes sport without reproduction of medial tibial stress syndrome symptoms (achieved / not achieved). |
Baseline (Week 0), Week 4 and Week 8.
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RE-172-2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The results data collected , de-identified individual participant data will be shared.
Prazo de Compartilhamento de IPD
6 months after the publication of the manuscript
Critérios de acesso de compartilhamento IPD
The data can be requested from the corresponding author
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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