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- Ensaio Clínico NCT07594223
Efficacy of Activator Trigger Point and Shock Wave Therapy on Pain and Function in Active Upper Trapezius Trigger Points: A Randomized Controlled Study
This study will be conducted as a randomized controlled trial to evaluate the efficacy of trigger point activator and extracorporeal shock wave therapy in patients with active myofascial trigger points in the upper fibers of the trapezius muscle. Participants who meet the inclusion criteria will be recruited and informed consent will be obtained prior to participation. The subjects will then be randomly allocated into two equal groups. Group A: will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle. Group B: will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period. Outcome measures will be assessed before the beginning of the treatment program and after completion of the intervention period. Pain intensity and pressure pain threshold will be assessed using an algometer. Functional disability related to the neck will be evaluated using the Neck Disability Index (NDI). All collected data will be recorded and statistically analyzed to determine the effectiveness of both treatment modalities in reducing pain and improving functional outcomes.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study will be conducted as a randomized controlled trial to evaluate the efficacy of trigger point activator and extracorporeal shock wave therapy in patients with active myofascial trigger points in the upper fibers of the trapezius muscle. Participants who meet the inclusion criteria will be recruited and informed consent will be obtained prior to participation. The subjects will then be randomly allocated into two equal groups. Group A: will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle. Group B: will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period. Outcome measures will be assessed before the beginning of the treatment program and after completion of the intervention period. Pain intensity and pressure pain threshold will be assessed using an algometer. Functional disability related to the neck will be evaluated using the Neck Disability Index (NDI). All collected data will be recorded and statistically analyzed to determine the effectiveness of both treatment modalities in reducing pain and improving functional outcomes. 15. Participants of the study:
- The number of participants: 200 (50 per group to ensure 40 completers per arm after attrition).
Important characteristics
- Adult (27:40 years):
- Gender: both gender
Diagnosis: Active upper trapezius trigger points Inclusion criteria
- Male or female participants aged between 25 and 40 years.
- Body Mass Index (BMI) between 20 and 30 kg/m².
- Presence of active myofascial trigger points in the upper fibers of the trapezius muscle confirmed by clinical examination.
- Complaints of neck pain associated with upper trapezius trigger points.
- Ability and willingness to participate in the treatment sessions and follow the study protocol.
Exclusion criteria:
- History of neck trauma, cervical spine fracture, or cervical spine surgery.
- Presence of neurological disorders affecting the cervical region.
- Presence of cervical disc prolapse or severe cervical spine pathology.
- Diagnosis of fibromyalgia or systemic musculoskeletal disorders.
- Presence of skin diseases, wounds, or infections at the treatment area.
- Patients with malignancy or severe systemic diseases.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mina Wahba, phD
- Número de telefone: +062 3707068
- E-mail: mina.magdy@the.suezuni.edu.eg
Locais de estudo
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Suez, Egito
- Suez Uni
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Contato:
- Doha Hamed, PhD
- E-mail: dohahamed@buc.edu.eg
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
1. Male or female participants aged between 25 and 40 years. 2. Body Mass Index (BMI) between 20 and 30 kg/m². 3.Presence of active myofascial trigger points in the upper fibers of the trapezius muscle confirmed by clinical examination.
- Complaints of neck pain associated with upper trapezius trigger points. 5. Ability and willingness to participate in the treatment sessions and follow the study protocol.
Exclusion Criteria:
- 1. History of neck trauma, cervical spine fracture, or cervical spine surgery. 2. Presence of neurological disorders affecting the cervical region. 3. Presence of cervical disc prolapse or severe cervical spine pathology. 4. Diagnosis of fibromyalgia or systemic musculoskeletal disorders. 5. Presence of skin diseases, wounds, or infections at the treatment area. 6. Patients with malignancy or severe systemic diseases.
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 |
|---|---|
|
Experimental: treatment
receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.
|
will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.
|
|
Comparador Ativo: Shockwave
will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period.
|
will receive extracorporeal shock wave therapy applied to the same region.
12.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Neck Disability Index (NDI)
Prazo: 6 weeks
|
Questionnaire assessing neck function valid and reilable
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6 weeks
|
|
VAS
Prazo: 6 weeks
|
Pain score
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- SuezU1
Plano para dados de participantes individuais (IPD)
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