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- Ensaio Clínico NCT07567703
Comparison of Laser and Shockwave Therapy for Piriformis Syndrome With Adjunctive Exercise (LASWEX-PS)
A Comparative Study of Laser Therapy and Shockwave Therapy in the Treatment of Piriformis Syndrome: The Role of Exercise as an Adjunctive Treatment
Visão geral do estudo
Status
Condições
Descrição detalhada
Piriformis syndrome is a common musculoskeletal condition that contributes to chronic low back and gluteal pain, often leading to functional limitations. This prospective randomized controlled trial was conducted to compare the effectiveness of low-level laser therapy (LLLT) combined with therapeutic exercise versus radial extracorporeal shockwave therapy (rESWT) combined with exercise in patients with piriformis syndrome.
A total of 70 participants were randomly assigned into two equal groups. Both interventions were administered over a period of four weeks, with follow-up assessment conducted one month post-treatment. Outcome measures included pain intensity using the Visual Analog Scale (VAS), functional disability using the Oswestry Disability Index (ODI), hip range of motion (ROM), and quality of life using the Short Form-36 (SF-36).
Inclusion criteria:
Adults aged 18 to 65 years who had a confirmed diagnosis of piriformis syndrome. piriformis syndrome required a positive FAIR test and EMG evidence of sciatic nerve involvement. Eligible participants had chronic symptoms lasting at least three months and a baseline Visual Analog Scale (VAS) pain score of ≥4.
Exclusion criteria:
Participants were excluded if they had a history of surgical interventions involving the lumbar spine, sacroiliac joint, or hip; systemic inflammatory diseases such as ankylosing spondylitis or rheumatoid arthritis; neurological disorders impairing lower limb function; or were pregnant or lactating. Individuals with malignancy, bleeding disorders, or pacemaker implantation Pain Intensity measured by Visual Analogue Scale (VAS), Functional Disability - Oswestry Disability Index (ODI) was used to assess functional impairment in lower back pain and functional limitations., Range of Motion (ROM):It had been used to assess joint mobility will be assessed using a standard goniometer, Quality of Life - Short Form-36 (SF-36): Health-related quality of life will be assessed using the Short Form-36 (SF-36) questionnaire assessment performed at baseline , posttreatment after 4 weeks and 3 months follow up post treatment
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Cairo, Egito
- Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults aged 18 to 65 years who had a confirmed diagnosis of piriformis syndrome. piriformis syndrome required a positive FAIR test and EMG evidence of sciatic nerve involvement. Eligible participants had chronic symptoms lasting at least three months and a baseline Visual Analog Scale (VAS) pain score of ≥4.
Exclusion Criteria:
- Participants were excluded if they had a history of surgical interventions involving the lumbar spine, sacroiliac joint, or hip; systemic inflammatory diseases such as ankylosing spondylitis or rheumatoid arthritis; neurological disorders impairing lower limb function; or were pregnant or lactating. Individuals with malignancy, bleeding disorders, or pacemaker implantation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Laser + Exercise
Participants receive low-level laser therapy combined with therapeutic exercise for management of piriformis syndrome.
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Participants receive low-level laser therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.
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Experimental: Shockwave + Exercise Group
Participants receive radial extracorporeal shockwave therapy combined with therapeutic exercise.
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Participants receive radial extracorporeal shockwave therapy combined with a structured therapeutic exercise program for management of piriformis syndrome.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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1. Pain Intensity
Prazo: 1. Baseline, post-intervention (4 weeks), and 3-month follow-up
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1. Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
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1. Baseline, post-intervention (4 weeks), and 3-month follow-up
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2. Hip Range of Motion
Prazo: Baseline, post-intervention (4 weeks), and 3-month follow-up
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Hip joint range of motion will be measured in degrees using a standard universal goniometer.
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Baseline, post-intervention (4 weeks), and 3-month follow-up
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3. Quality of Life
Prazo: Baseline, post-intervention (4 weeks), and 3-month follow-up
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Health-related quality of life will be assessed using the SF-36 questionnaire.
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Baseline, post-intervention (4 weeks), and 3-month follow-up
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Functional Disability
Prazo: Baseline, post-intervention (4 weeks), and 3-month follow-up
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Functional disability will be evaluated using the Oswestry Disability Index (ODI), which measures disability related to low back and gluteal pain.
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Baseline, post-intervention (4 weeks), and 3-month follow-up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sahar M Abdelmutilibe, PHD, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
Publicações e links úteis
Publicações Gerais
- MF DEO, Johnson DS, Demchak T, Tomazoni SS, Leal-Junior EC. Low-intensity LASER and LED (photobiomodulation therapy) for pain control of the most common musculoskeletal conditions. Eur J Phys Rehabil Med. 2022;58(2):282-9.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- Dor
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Doenças Neuromusculares
- Doenças do Sistema Nervoso Periférico
- Neuralgia
- Dor pélvica
- Mononeuropatias
- Síndromes de Compressão Nervosa
- Neuropatia ciática
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Síndrome do Músculo Piriforme
- Terapêutica
- Modalidades de fisioterapia
- Atendimento ao paciente
- Reabilitação
- Cuidados posteriores
- Continuidade do atendimento ao paciente
- Terapia a laser
- Fototerapia
- Terapia de exercícios
- Terapia com luz de baixo nível
Outros números de identificação do estudo
- FPTBSUREC/0212/15426 (Outro identificador: Faculty of Physical Therapy, Beni Suef University)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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