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- Ensaio Clínico NCT07598526
Comparative Effects of Mulligan Mobilization With and Without Myofascial Release Technique in Management of Post Traumatic Elbow Stiffness
13 de maio de 2026 atualizado por: Maryam Safdar, University of Faisalabad
The Randomize Clinical Trial will involve 30 participants with post traumatic elbow stiffness recruited from Madinah Teaching Hospital and Chiniot General hospital Faisalabad.
Consecutive sampling technique will be used.
Study will include individuals with >30° extension loss and <120° flexion, 50° in both directions for pronation-supination, who are 3-6 weeks post-POP removal from radiograph confirmation of skeletal/bone healing will be insured, who have elbow pain from 3 to 5/10 on NPRS and have fully healed fractures.
Both intra-articular and extra-articular injuries will be accepted.
DASH Score with 45 to 50 points.
Study will exclude pathological or acute fractures, burns, brain trauma, neurological or psychological disorders, history of pre-operative osteoarthritis.
Consent will be taken written and verbal from participants before including into study.
Patients will be allocated with online randomization generator method into 2 groups.
Group A will receive Mulligan Mobilization with Myofascial release technique, while Group B will receive Mulligan Mobilization alone.
Hot pack for 20 minutes before treatment and static stretching after treatment will apply in both groups.
Each stretch is performed 10 repetition with hold duration of 30 sec and rest period 15 sec between each stretch.
Total 3 sessions per week for 4 weeks (12 sessions) on alternative days will be given.
Outcome of study will be elbow pain, elbow range of motion (flexion and extension) and functional disability will be measure by using Numerical Pain Rating Scale, Universal Goniometer and Dash Questionnaire Score respectively.
Data will be investigated by using SPSS version 2023.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
Elbow stiffness is a disabling condition that interferes in daily living activities after trauma.
The study's goal is to compare the results of Mulligan Mobilization with and without Myofascial Release Technique in management of post traumatic elbow stiffness.
The Randomize Clinical Trial will involve 30 participants with post traumatic elbow stiffness recruited from Madinah Teaching Hospital and Chiniot General hospital Faisalabad.
Consecutive sampling technique will be used.
Study will include individuals with >30° extension loss and <120° flexion, 50° in both directions for pronation-supination, who are 3-6 weeks post-POP removal from radiograph confirmation of skeletal/bone healing will be insured, who have elbow pain from 3 to 5/10 on NPRS and have fully healed fractures.
Both intra-articular and extra-articular injuries will be accepted.
DASH Score with 45 to 50 points.
Study will exclude pathological or acute fractures, burns, brain trauma, neurological or psychological disorders, history of pre-operative osteoarthritis.
Consent will be taken written and verbal from participants before including into study.
Patients will be allocated with online randomization generator method into 2 groups.
Group A will receive Mulligan Mobilization with Myofascial release technique, while Group B will receive Mulligan Mobilization alone.
Hot pack for 20 minutes before treatment and static stretching after treatment will apply in both groups.
Each stretch is performed 10 repetition with hold duration of 30 sec and rest period 15 sec between each stretch.
Total 3 sessions per week for 4 weeks (12 sessions) on alternative days will be given.
Outcome of study will be elbow pain, elbow range of motion (flexion and extension) and functional disability will be measure by using Numerical Pain Rating Scale, Universal Goniometer and Dash Questionnaire Score respectively.
Data will be investigated by using SPSS version 2023.
Tipo de estudo
Intervencional
Inscrição (Estimado)
30
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
- Nome: Maryam Safdar Dr, MS Physical Therapy (MSK)
- Número de telefone: +92-3217978088
- E-mail: maryamsafdar.DPT@tuf.edu.pk
Estude backup de contato
- Nome: Dr Muhammad Ateeb, PhD Public Health
- Número de telefone: +92-3357333383
- E-mail: mateeb.oric@tuf.edu.pk
Locais de estudo
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Punjab Province
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Faisalābad, Punjab Province, Paquistão, 38000
- Outdoor Patient Department (OPD) of Madinah Teaching Hospital and Chiniot General Hospital, Faisalabad.
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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
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Participants aged between 17 and 44 years will be included in the study (Sun et al., 2025).
- Both male and female patients experiencing mild to moderate elbow pain (3/10 to 5/10 on NPRS) along with restricted range of motion will be eligible (Zulfqar et al., 2021).
- Subjects having elbow movement limitation of more than 30° in extension, flexion less than 120°, and 50° restriction in both pronation and supination will be included (Masci et al., 2020).
- Participants will be recruited 3 to 6 weeks after POP removal, and radiographic confirmation of bone/skeletal healing will be ensured before inclusion (Morrey et al., 2017).
- Patients with both intra-articular and extra-articular fractures will be considered eligible.
- Individuals with DASH scores ranging from 45 to 50 points will be included.
- Only patients willing to participate in the study will be enrolled.
Exclusion Criteria:
- Patients with a history of previous surgical excision will be excluded from the study (Zheng et al., 2018).
- Participants presenting with pathological fractures will not be included (Zulfqar et al., 2021).
- Patients in the acute stage of fracture will be excluded from participation (Zulfqar et al., 2021).
- Individuals with metabolic or malignant conditions causing elbow stiffness, such as gout or osteosarcoma, will not be eligible (Fusaro et al., 2014).
- Patients with elbow fractures associated with a history of metal implants will be excluded (Zheng et al., 2018).
- Individuals who have already received physiotherapy treatment or medication for the condition will not be included.
- Patients diagnosed with psychological illnesses that may interfere with following instructions will be excluded.
- Participants with brain trauma or referred neurological symptoms, including numbness, dizziness, or hyperesthesia, will not be considered (Fusaro et al., 2014).
- Patients with structural or postural abnormalities involving the shoulder or wrist will be excluded.
- Individuals with open skin wounds or burn injuries around the affected area will not be included.
- Patients with a pre-operative history of arthritis will also be excluded from the study.
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 |
|---|---|
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Experimental: Group A (Mulligan Mobilization with Myofascial Release Technique)
Participants in Group A will receive a structured treatment program including Mulligan mobilization along with myofascial release techniques aimed at reducing pain, improving functional disability, and enhancing elbow range of motion.
Each session will last 40-45 minutes and will be administered three times per week for four weeks.
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The patient will be positioned supine at the edge of the table with the shoulder abducted to 90°, elbow flexed, and forearm supinated.
The therapist will stabilize the distal humerus and use a belt around the pelvis while applying a sustained glide through the forearm.
Active elbow flexion/extension will be performed with gentle, pain-free overpressure at end range.
The technique will be repeated 6-10 times for 1-3 sets with 15-second rest intervals.
Myofascial release will be applied with the patient supine, elbow slightly flexed and forearm pronated.
The therapist will treat from lateral epicondyle to wrist extensors while the patient performs small elbow movements.
Both groups will receive a hot pack application for 20 minutes as a baseline treatment prior to the intervention, followed by static stretching after the session.
Each stretch will be performed for 10 repetitions, with a 30-second hold and a 15-second rest interval between stretches.
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Comparador Ativo: Group B (Mulligan Mobilization alone)
Participants in Group B will be treated with Mulligan Mobilization alone to help reduce pain and improve elbow range of motion.
The intervention will be delivered in 40-45 minute sessions, three times per week, for four consecutive weeks.
|
The patient will be positioned supine at the edge of the table with the shoulder abducted to 90°, elbow flexed, and forearm supinated.
The therapist will stabilize the distal humerus and use a belt around the pelvis while applying a sustained glide through the forearm.
Active elbow flexion/extension will be performed with gentle, pain-free overpressure at end range.
The technique will be repeated 6-10 times for 1-3 sets with 15-second rest intervals.
Both groups will receive a hot pack application for 20 minutes as a baseline treatment prior to the intervention, followed by static stretching after the session.
Each stretch will be performed for 10 repetitions, with a 30-second hold and a 15-second rest interval between stretches.
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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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Elbow pain
Prazo: Baseline and week 4
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The Numeric Pain Rating Scale (NPRS) is an 11-point scale used to assess pain intensity.
The scale ranges from 0, indicating no pain, to 10, representing the worst imaginable pain.
It is considered a reliable and valid tool for evaluating changes in pain severity over time
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Baseline and week 4
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Elbow range of motion
Prazo: Baseline and week 4
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The universal goniometer is a reliable and effective instrument commonly used to assess elbow joint range of motion
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Baseline and week 4
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Functional disability
Prazo: Baseline and Week 4
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The DASH questionnaire is designed to evaluate upper limb function and related symptoms.
It assesses the level of difficulty an individual experiences while performing daily activities involving the arm, shoulder, and hand due to pain, weakness, or movement limitations.
The questionnaire contains 30 items, and scores range from 0 (no disability) to 100 (maximum disability), with higher scores indicating greater functional impairment
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Baseline and Week 4
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Dr Maryam Safdar, The University of Faisalabad
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Pourahmadi MR, Mohsenifar H, Dariush M, Aftabi A, Amiri A. Effectiveness of mobilization with movement (Mulligan concept techniques) on low back pain: a systematic review. Clin Rehabil. 2018 Oct;32(10):1289-1298. doi: 10.1177/0269215518778321. Epub 2018 May 30.
- Kain J, Martorello L, Swanson E, Sego S. Comparison of an indirect tri-planar myofascial release (MFR) technique and a hot pack for increasing range of motion. J Bodyw Mov Ther. 2011 Jan;15(1):63-7. doi: 10.1016/j.jbmt.2009.12.002. Epub 2010 Jan 27.
- Masci G, Cazzato G, Milano G, Ciolli G, Malerba G, Perisano C, Greco T, Osvaldo P, Maccauro G, Liuzza F. The stiff elbow: Current concepts. Orthop Rev (Pavia). 2020 Jun 25;12(Suppl 1):8661. doi: 10.4081/or.2020.8661. eCollection 2020 Jun 29.
- Zhang D, Nazarian A, Rodriguez EK. Post-traumatic elbow stiffness: Pathogenesis and current treatments. Shoulder Elbow. 2020 Feb;12(1):38-45. doi: 10.1177/1758573218793903. Epub 2018 Aug 8.
- Sevik Kacmaz K, Unver B. Immediate Effects of Mulligan Mobilization on Elbow Proprioception in Healthy Individuals: A Randomized Placebo-Controlled Single-Blind Study. J Manipulative Physiol Ther. 2023 Jan;46(1):59-64. doi: 10.1016/j.jmpt.2023.05.001. Epub 2023 Jul 7.
- Birinci T, Razak Ozdincler A, Altun S, Kural C. A structured exercise programme combined with proprioceptive neuromuscular facilitation stretching or static stretching in posttraumatic stiffness of the elbow: a randomized controlled trial. Clin Rehabil. 2019 Feb;33(2):241-252. doi: 10.1177/0269215518802886. Epub 2018 Oct 10.
- van Rijn SF, Zwerus EL, Koenraadt KL, Jacobs WC, van den Bekerom MP, Eygendaal D. The reliability and validity of goniometric elbow measurements in adults: A systematic review of the literature. Shoulder Elbow. 2018 Oct;10(4):274-284. doi: 10.1177/1758573218774326. Epub 2018 Jun 3.
- Zheng W, Liu J, Song J, Fan C. Risk factors for development of severe post-traumatic elbow stiffness. Int Orthop. 2018 Mar;42(3):595-600. doi: 10.1007/s00264-017-3657-1. Epub 2017 Oct 7.
- Young I, Dunning J, Mourad F, Escaloni J, Bliton P, Fernandez-de-Las-Penas C. Clinimetric analysis of the numeric pain rating scale, patient-rated tennis elbow evaluation, and tennis elbow function scale in patients with lateral elbow tendinopathy. Physiother Theory Pract. 2025 Aug;41(8):1712-1720. doi: 10.1080/09593985.2025.2450090. Epub 2025 Jan 10.
- Sun Z, Li J, van Riet R, Ho PC, Hildebrand KA, Puah KL, Shih JT, Li Z, Chanlalit C, Kekatpure AL, Zhang K, Liu S, Gong M, Huang F, Yan H, Mi J, Lu J, Zha Y, Xiang Z, Xiang M, Li F, Jiang S, Liu W, Zhong B, Ding J, Ruan H, Ouyang Y, Wang W, Yu S, Chen S, Qian Y, Xu Y, Hu Y, Xu J, Jiang X, Jeon IH, Fan C. Clinical guideline on the open arthrolysis for post-traumatic elbow stiffness in adult patients. J Shoulder Elbow Surg. 2026 Mar;35(3):811-825. doi: 10.1016/j.jse.2025.07.015. Epub 2025 Aug 25.
- Ling SK, Lui TH, Faan YS, Lui PW, Ngai WK. Post-traumatic elbow rotational stiffness. Shoulder Elbow. 2014 Apr;6(2):119-23. doi: 10.1177/1758573214524935. Epub 2014 Mar 3.
- He X, Fen Q, Yang J, Lei Y, Heng L, Zhang K. Risk Factors of Elbow Stiffness After Open Reduction and Internal Fixation of the Terrible Triad of the Elbow Joint. Orthop Surg. 2021 Apr;13(2):530-536. doi: 10.1111/os.12879. Epub 2021 Feb 22.
- Fusaro I, Orsini S, Stignani Kantar S, Sforza T, Benedetti MG, Bettelli G, Rotini R. Elbow rehabilitation in traumatic pathology. Musculoskelet Surg. 2014 Apr;98 Suppl 1:95-102. doi: 10.1007/s12306-014-0328-x. Epub 2014 Mar 25.
- Fan M, Xu F, Fei C, Liu Y, Yang Z, Song Z. Post-traumatic elbow stiffness: etiology, risk factors and current treatments. Front Surg. 2025 Aug 26;12:1643326. doi: 10.3389/fsurg.2025.1643326. eCollection 2025.
- Akhtar A, Hughes B, Watts AC. The post-traumatic stiff elbow: A review. J Clin Orthop Trauma. 2021 May 19;19:125-131. doi: 10.1016/j.jcot.2021.05.006. eCollection 2021 Aug.
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 (Estimado)
20 de maio de 2026
Conclusão Primária (Estimado)
20 de setembro de 2026
Conclusão do estudo (Estimado)
20 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
13 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de maio de 2026
Primeira postagem (Real)
20 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TUF/EIRB/179/26
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 .
Ensaios clínicos em Group A (Mulligan Mobilization with Myofascial Release Technique)
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Riphah International UniversityAinda não está recrutandoDor lombar | Estenose espinalPaquistão
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Riphah International UniversityAinda não está recrutandoFascite Plantar | Síndrome da Dor no CalcanharPaquistão