Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Weighted Dangling Exercises vs Vastus Medialis Oblique Muscle Neuromuscular Stimulation for Knee Osteoarthritis

8 de julho de 2026 atualizado por: Mahnoor Fatima, University of Lahore

Effectiveness of Weighted Dangling Exercises Versus Vastus Medialis Oblique Muscle Neuromuscular Stimulation in Patients With Knee Osteoarthritis

This randomized controlled trial aims to compare the effectiveness Weighted dangling exercises versus vastus medialis oblique muscle neuromuscular electrical stimulation(VMO+NMES) in patients with knee osteoarthritis. The study will recruit 48 participants (accounting for 10% attrition), aged 40-60 years, from University of Lahore Teaching Hospital using convenience sampling. Participants will be randomly allocated into two groups: an interventional group receiving WDE and other interventional group undergoing VMO strength training with NMES. Both interventions will be administered three times per week for 8 weeks under professional supervision. Outcome measures including pain intensity (NPRS), Functional Disability (Western Ontario and McMaster Universities Osteoarthritis Index),Muscle Strength (MMT) will be assessed at baseline, 4 weeks, and 8 weeks. Data will be analyzed using SPSS, with appropriate parametric or non-parametric tests applied after checking data normality. Ethical approval will be obtained, informed consent will be secured, and participant confidentiality will be strictly maintained.

Visão geral do estudo

Descrição detalhada

This study is a single-blinded randomized controlled trial designed to evaluate and compare the therapeutic effectiveness Weighted dangling exercises versus vastus medialis oblique muscle neuromuscular electrical stimulation(VMO+NMES) in patients with knee osteoarthritis. The study will recruit 48 participants (accounting for 10% attrition), aged 40-60 years, from University of Lahore Teaching Hospital over a duration of 9 months following synopsis approval. A total sample size of 48 participants (24 per group) has been determined using epitool software, based on theWestern Ontario and McMaster Universities Osteoarthritis Index) , with a confidence level of 95%, power of 80%, and a 10% attrition allowance. Participants aged 40-60 years, of both genders, with clinically confirmed knee osteoarthritis. Symptoms of unilateral knee pain and crepitus persist for at least 6 months during ascending and descending motion. Radiographic Knee osteoarthritis examination. Exclusion includes recent surgery (within three months) history of hip or knee joint replacement, tibial osteotomy, or those with systemic arthritis, history of trauma such as knee fracture and other with muscular disease of neurological disorders that would affect lower extremity function is excluded. Eligible participants will be enrolled after providing written informed consent and randomized using a computer-generated block randomization method, with allocation concealment ensured through sealed opaque envelopes. Outcome assessors will be blinded to group allocation to minimize assessment bias. The one group will receive weighted dangling exercise. A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down. Other group receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO). The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical. The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF. Sessions will be conducted three times weekly for 8 weeks, totaling 24 supervised sessions. Primary and secondary outcome measures include pain intensity (Numeric Pain Rating Scale),theWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC), muscle strength, assessed at baseline, 4 weeks, and 8 weeks post-intervention. Data will be analyzed using SPSS (version 25/27). Descriptive statistics will summarize participant characteristics, while inferential statistics will be applied based on data distribution, with significance determined accordingly. Ethical considerations will strictly adhere to the guidelines of the Institutional Research Ethics Board (IREB), University of Lahore. Participant confidentiality, voluntary participation, right to withdraw, and safety monitoring will be ensured throughout the study. No serious adverse effects are anticipated.

Tipo de estudo

Intervencional

Inscrição (Estimado)

48

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

    • Punjab Province
      • Lahore, Punjab Province, Paquistão, 54000
        • Recrutamento
        • University of Lahore Teaching Hospital, Lahore, Pakistan
        • Contato:
        • Contato:
        • Investigador principal:
          • Mahnoor Fatima, MS MSK
        • Investigador principal:
          • Hafiza Sana Ashraf, PhD PT*

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

Both genders and aged between 40 and 60 years. Symptoms of unilateral knee pain and crepitus persist for at least 6 months during ascending and descending motion. Radiographic KOA; grade 2 or more according to Kellgren and Lawrence scale. Patient referred by an orthopedic physician Those who have taken oral corticosteroids within the last month or who received intra-articular corticosteroid injection or analgesic injection intervention for hip or knee pain within the last 3 month

Exclusion Criteria:

  • Recent surgery (within three months) history of hip or knee joint replacement, tibial osteotomy, orthoses with systemic arthritis, history of trauma such as knee fracture and other with muscular disease of neurological disorders that would affect lower extremity function is excluded.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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: interventional group A
The experimental group A will receive weighted dangling exercise. A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down
This group receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO). The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical. The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF
Comparador Ativo: interventional group B
Experimental group B receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO). The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical. The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF
The one group will receive weighted dangling exercise. A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down

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,4 weeks and 8 weeks
Pain in this study is defined as subjective discomfort in the knee joint caused by osteoarthritis. It was evaluated using the Numeric Pain Rating Scale (NPRS), which is a reliable and proven technique for quantifying pain intensity. Participants score their discomfort on an 11-point scale, with 0 indicating "no pain" and 10 representing "the worst pain imaginable.
baseline,4 weeks and 8 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Functional disability:(WOMAC)
Prazo: Baseline 4 weeks and 8 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which is a well-used and validated questionnaire. The WOMAC measures three dimensions: pain (5 things), stiffness (2 items), and physical function (17 items). Each item is assessed on a scale of 0 (no difficulty) to 4 (severe difficulty), with a total WOMAC score of 0-96. Higher scores indicate greater functional disability. The questionnaire examines pain while walking or ascending stairs, stiffness in the morning or later in the day, and difficulty with sitting, standing, and lifting objects.
Baseline 4 weeks and 8 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Mahnoor Fatima, MS MSK*, University Institute of Physical Therapy, University of Lahore
  • Investigador principal: Hafiza Sana Ashraf, PhD PT*, University Institute of Physical Therapy, University of Lahore

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de maio de 2026

Conclusão Primária (Estimado)

25 de agosto de 2026

Conclusão do estudo (Estimado)

10 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

8 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de julho de 2026

Primeira postagem (Real)

14 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • UOL/IREB/25/15/03/26 (Outro identificador: University Of Lahore)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

Se inscrever