- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Philip Lu
- Phone Number: 604-562-0028
- Email: philip.lu@mcgill.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada
- Montreal General Hospital
-
Contact:
- Philip Lu
- Phone Number: 604-562-0028
- Email: philip.lu@mcgill.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Time Frame: Day 1
|
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
9-item Visit-Specific Satisfaction Questionnaire (VSQ-9)
Time Frame: Day 1
|
9-item Visit-Specific Satisfaction Questionnaire (VSQ-9)
|
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-12105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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