Temporomandibular Disorder (TMD)NCT07423234
Patient Education, Self-management and Physiotherapy for Chronic Temporomandibular Disorders
A study testing Patient education and self-management and Usual treatment (multimodal) in people with Temporomandibular Disorder (TMD) and Chronic Pain, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
The goal of this clinical trial is to understand whether a simple education and self-management program with home exercises can reduce pain and improve daily function in adults with long-lasting jaw pain caused by temporomandibular disorders (TMD) as much as a more intensive hands-on physiotherapy approach. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Disorder (TMD), Chronic Pain
- What is being tested?
- Patient education and self-management and Usual treatment (multimodal)
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jan 2026to Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic of painful TMD according to axis 1 of DC/TMD
- Experiencing rest pain for at least 3 months
- With a minimum pain intensity of 3 on a 10-point Numeric Pain Rating Scale (NPRS)
Who cannot join
- History of jaw surgery
- Recent trauma to head or jaw
- Ongoing dental treatment
- History of rheumatologic condition
- Severe psychiatric condition (e.g severe anxiety or severe depression)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Education, Self-management and Physiotherapy in the Management of Chronic Painful Temporomandibular Disorders : a Two-arm Randomized Controlled Trial
The goal of this clinical trial is to understand whether a simple education and self-management program with home exercises can reduce pain and improve daily function in adults with long-lasting jaw pain caused by temporomandibular disorders (TMD) as much as a more intensive hands-on physiotherapy approach.
The main questions it aims to answer are:
Read more
- Does an education and self-management exercise program reduce jaw pain, improve jaw function and reduce how much pain interferes with daily activities?
- Does this program improve outcomes similarly to the usual treatment for TMDs, which includes also manual therapy and supervised exercise sessions?
Researchers will compare an education and self-management program with home exercises to usual physiotherapy care to see which approach leads to better pain relief and daily functioning over time.
Participants will:
Attend three evaluation visits (at the start of the study, after 6 weeks, and after 16 weeks);
Be assigned to one of two treatment groups:
- A group receiving two physiotherapy-supervised education and self-management sessions with personalized home exercises; or
- A group receiving six physiotherapy usual treatment sessions, which may include education, exercises, and hands-on therapy;
Participants will complete questionnaires about:
Jaw pain, Jaw function, Body pain, Neck disability, Oral behaviors, Pain catastrophizing, Fear of movement, Confidence in managing pain.
Measures of mouth opening will be taken (non-painful, maximal and maximal with assistance) with a ruler at all time points.
This study includes adults aged 18 to 65 years who have jaw pain for at least 3 months.
- Conditions
- Temporomandibular Disorder (TMD), Chronic Pain
- Being tested
- Patient education and self-management, Usual treatment (multimodal)
- Keywords
- Temporomandibular Disorders, Patient education, Self-management, Chronic pain, Randomized controlled trial, Pain management
- Medical subject headings
- Temporomandibular Joint Disorders, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education and self-managementBehavioural
This intervention is a structured, patient-centered education and self-management program for adults with painful temporomandibular disorders (TMD). It is delivered one-on-one by a trained physiotherapist and focuses on improving understanding of jaw pain, reducing harmful oral habits, and restoring confident jaw movement.
Participants receive individualized education about TMD, pain mechanisms, stress and habit influences, and practical strategies to manage daily activities such as chewing, speaking, posture, and sleep. The program addresses fear of movement and emphasizes safe, gradual jaw use.
Each participant is given a personalized home exercise program targeting jaw and neck mobility, coordination, and muscle relaxation. Participants also set personal goals to support long-term self-management.
Usual treatment (multimodal)Procedure or surgery
Usual care consists of a comprehensive physiotherapy program commonly used for adults with temporomandibular disorders (TMD). Treatment is delivered by a trained physiotherapist.
Interventions may include hands-on manual therapy to reduce muscle tension, joint mobilizations to restore normal jaw movement, and supervised therapeutic exercises targeting jaw and neck mobility, coordination, and strength. Participants also receive education and advice regarding posture, oral habits, and daily activity modifications. Participants will have prescribed at-home therapeutic exercises (up to 5 jointly chosen by PT and patient).
Participants will receive the same written booklet as the education and self-management arm.
| Study group | Role | What they receive |
|---|---|---|
| Patient education and self-management | Experimental | Each of the two sessions will be conducted individually with one of two physiotherapists and will last 45 minutes each. The first session will be used at baseline to deliver proper insights to the patient regarding normal physiology and their TMD, pain pathophysiology using references and visual aids (i.e. video, biomechanical demonstration on human skeleton model) to facilitate understanding. Depending on clinical presentation and scores to self-administered questionnaires, counseling and recommendations will be tailored. Lastly, an exercise program, including self-relief manual techniques and rehabilitation exercises for posture, mobility and strength of the neck and jaw will be demonstrated, practiced and prescribed to the participants (up to 5 exercises). At home, each patient will have access to an informational binder featuring the recommendations and prescribed exercise program to ensure patient's capacity to follow the intended program. Receives: Behavioral: Patient education and self-management |
| Usual treatment | Active comparator | This group will be offered six (30 min, 1x/week) in-clinic PT-supervised sessions from one of two experienced physiotherapists over a 5-week period. The usual intervention group will receive personalized care tailored to each participant's presentation with the intention of reducing pain, increasing mobility and strength, and optimizing daily function. Care provided will not be standardized and will include a combination of manual therapy techniques, at-home exercises (up to 5 jointly chosen by PTs and participants) and education regarding potential contributing factors to the presenting TMD. Treatments will not only focus on the TMJ, but may also involve treatment for the neck, head and shoulder griddle based on the physiotherapist's expert clinical reasoning. All therapies will be documented for analysis. Receives: Procedure: Usual treatment (multimodal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristic Pain Intensity (CPI)
Graded Chronic Pain Scale (version 2.0). This scale measures two subscales : the Characteristic Pain Intensity (CPI) and the Pain Interference.
CPI is used to quantify a patient's jaw and face pain experience by averaging three scores from the past 6 months: current pain, average pain, and worst pain, on a 0-10 scale. The final score ranges from 0 to 100, with higher scores indicating more pain.
Measured: From enrollement to the last evaluation (at 16 weeks after the first treatment)
Pain Interference
Pain Interference (subscale of the GCPS 2.0) is assessed by measuring how pain restricts daily, social, family, and work activities over the past 30 days, using a 0-10 scale. The final score ranges from 0 to 100, with higher scores indicating greater pain interference.
Measured: From enrollement to the last evaluation (at 16 weeks after the first treatment)
Secondary outcomes (8)
Jaw function
Jaw Functional Limitation Scale-20. This 20-item questionnaire used to assess mastication, vertical jaw mobility, and communication limitations, with total scores ranging from 0 to 200. Higher scores indicate greater functional limitations.
Measured: From enrollement to last evaluation (at 16 weeks after the first treatment)
Body Pain
Brief Pain Inventory. This questionnaire uses a 0-10 numeric rating scale for 11 items, focusing on body pain severity and interference. It calculates two main scores: a 4-item Pain Severity Score (mean of worst, least, average, and current pain) and a 7-item Pain Interference Score (mean of disruption to daily life). The final scores for both pain and interference ranges from 0 to 10, where a higher score indicates greater pain or interference.
Measured: From enrollment to last evaluation (at 16 weeks after the first treatment)
Neck disability
Neck Disability Index (NDI) the NDI is a 10-section questionnaire assessing self-rated neck pain, with each section scored from 0 (no pain) to 5 (worst pain). The total raw score ranges from 0 to 50, where higher scores indicate greater disability related to the neck.
Measured: From enrollment to last evaluation (at 16 weeks after the first treatment)
Jaw mobility
A stainless steel ruler will be used to measure the jaw range of motion (opening, protrusion, laterotrusions). Measures will be taken in millimeters.
Measured: From enrollment to last evaluation (at 16 weeks after the first treatment)
Catastrophizing
Pain Catastrophizing Scale (PCS). The PCS is a 13-item tool assessing rumination, magnification, and helplessness regarding pain, using a 0-4 scale (0=never, 4=always). Total scores range from 0-52, with higher scores indicating greater catastrophizing.
Measured: From enrollment to last evaluation (at 16 weeks after the first treatment)
Kinesiophobia
Tampa Scale of Kinesiophobia (TSK-TMD). The TSK-TMD is a 17-item questionnaire (range 17-68) used to measure fear of movement and re-injury, with higher scores indicating greater fear.
Measured: From enrollment to last evaluation (at 16 weeks after the first treatment)
Self-efficacy
Patient Self-Efficacy Questionnaire-10 (PSEQ-10) The PSEQ-10 is a 10-item tool measuring a patient's confidence in performing activities despite pain. Items are rated on a 7-point scale (0 = "Not at all confident" to 6 = "Completely confident"), yielding a total score from 0-60. Higher scores indicate stronger self-efficacy.
Measured: From enrollment to last evaluation (at 16 weeks after the first treatment)
Oral Behaviors
Oral Behavior Checklist (OBC). The OBC is a 21-item questionnaire (2 sleep, 19 awake) that rates parafunctional habits on a 5-point Likert scale (0-4) over the past month, with total scores ranging from 0-84. A higher score indicates a higher risk of TMD related to oral behaviors.
Measured: From enrollement to last evaluation (at 16 weeks after the first treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start16 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorder (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Desmeules, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423234
- Sponsor's protocol ID
- 2025-3822
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications will be available upon reasonable request to the corresponding author. This includes primary and secondary outcome measures, baseline demographic and clinical characteristics, and study time-point data used for statistical analyses. The full study protocol, data dictionary, and statistical analysis plan will also be available upon request. Data will be shared in a de-identified format and in accordance with ethical approvals and applicable privacy regulations.