- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07560917
Temporomandibular Disorder (TMD) Diagnostic Concordance Between Physiotherapist and Surgeon (TMD)
Improving Access and Care Quality for Temporomandibular Disorder Patients - a Prospective Study to Examine Diagnostic Concordance Between Advanced-practice Physical Therapist and Oral and Maxillofacial Surgeon
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Temporomandibular disorders (TMD), involving the temporomandibular joint and masticatory muscles, are the leading cause of orofacial pain, affecting approximately 5-12% of the global population and generating an estimated $4 billion in annual healthcare costs. While 50-90% of individuals experience symptom relief through non-surgical interventions, fewer than 10% ultimately require surgical treatment. For patients who do not respond to conservative management, referral to a medical specialist is typically necessary to guide further care. In Canada, however, high demand for specialized services results in prolonged wait times. At the McGill Oral and Maxillofacial Surgery (OMFS) Division, patients can wait more than six months for an initial consultation and over a year for a surgical procedure. When accounting for additional delays related to diagnostic imaging and prior referrals, total wait times may exceed two years. These delays can have deleterious consequences, including worsening pain, increased functional disability, and a significant decline in quality of life for patients awaiting timely interventions. Above all, in the absence of a structured triage process, many patients are prematurely referred to surgical services, often before exhausting appropriate non-surgical options. This contributes to unnecessary delays in care, increased healthcare costs, and excessive demand on already overburdened speciality clinics.
The implementation of innovative care models led by advanced practice physiotherapists (APPTs) offers a promising solution. APPTs are highly trained health professionals with advanced competencies in musculoskeletal assessment, differential diagnosis, and evidence-based management, with the ability, depending on regulated scope of practice, to independently recommend investigations, initiate treatment plans, and make referrals when necessary. Advanced practice physiotherapy (APPT) models of care have been successfully deployed in various specialized care settings-such as orthopaedics, neurosurgery and rheumatology, where they have improved patient flow, reduced wait times, and maintained or improved patients' clinical outcomes. In these contexts, APPTs function as a first-contact autonomous practitioners, managing a substantial proportion of MSKD cases that would otherwise be directed to physicians or surgeons.
By integrating APPTs into the triage pathway for TMJ referrals, patients could be more effectively directed toward appropriate non-surgical care, such as physiotherapy, education, and self-management strategies, when surgical intervention is not warranted. This approach would help preserve the Oral and Maxillofacial Surgery department resources for patients with conditions that truly require surgical expertise. While APPT models have been successfully implemented and evaluated in various musculoskeletal care settings, no studies to date have described or assessed the implementation of such a model specifically for the management and triage of TMDs. This represents a significant gap in the literature and an important opportunity to explore the potential benefits of APPT-led care in improving access and efficiency in specialized orofacial pain services.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Philip Lu
- Número de telefone: 604-562-0028
- E-mail: philip.lu@mcgill.ca
Locais de estudo
-
-
Quebec
-
Montreal, Quebec, Canadá
- Montreal General Hospital
-
Contato:
- Philip Lu
- Número de telefone: 604-562-0028
- E-mail: philip.lu@mcgill.ca
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Referred for new consultation at the MUHC TMJ clinic for temporomandibular joint (TMJ) pain or dysfunction
- Residents of the province of Quebec and benefiaries of provincial universal health insurance coverage (Régie de l'Assurance Maladie du Québec - RAMQ)
- Be able to understand and communicate in either French of English
- Be legally capable of providing informed consent
Exclusion Criteria:
- Presenting for a follow-up visit (i.e., not a new consultation)
- Have undergone TMJ surgery within the past six months
- Referred directly from a recognized orofacial pain dentist or oral medicine specialist
- Referred for acute TMJ trauma requiring urgent management (e.g., fractures, dislocations)
- Present with complex or multi-system pathology that could confound the diagnostic process and are not related to TMD
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Physiotherapy Assessment
|
This is a non-randomized study as each participant will undergo two independent clinical assessments: one performed by the advanced-practice physical therapist (APPT) and one by the oral and maxillofacial surgeon (OMFS) and/or resident under supervision. For logistical and feasibility reasons, the APPT will conduct the first assessment. After a brief rest period, the participant will be seen by the OMFS. Both clinicians will be blinded to each other's findings, and participants will be explicitly instructed not to share any information from the first assessment during the second. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Prazo: Day 1
|
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
|
Day 1
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
9-item Visit-Specific Satisfaction Questionnaire (VSQ-9)
Prazo: Day 1
|
9-item Visit-Specific Satisfaction Questionnaire (VSQ-9)
|
Day 1
|
Colaboradores e Investigadores
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
- Doenças musculoesqueléticas
- Doenças estomatognáticas
- Doenças do Sistema Nervoso
- Processos Patológicos
- Doenças Neuromusculares
- Doenças articulares
- Doenças dos maxilares
- Doenças Mandibulares
- Desordens Craniomandibulares
- Condições Patológicas, Sinais e Sintomas
- Doença
- Doenças Musculares
- Distúrbios da Articulação Temporomandibular
Outros números de identificação do estudo
- 2026-12105
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .