Chronic Pain, Temporomandibular Disorder (TMD)
Conditions
Keywords
Temporomandibular Disorders, Patient education, Self-management, Chronic pain, Randomized controlled trial, Pain management
Brief 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. The main questions it aims to answer are: 1. Does an education and self-management exercise program reduce jaw pain, improve jaw function and reduce how much pain interferes with daily activities? 2. 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: 1. A group receiving two physiotherapy-supervised education and self-management sessions with personalized home exercises; or 2. 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.
Interventions
BEHAVIORALPatient education and self-management
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.
PROCEDUREUsual treatment (multimodal)
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.
Sponsors
Ciusss de L'Est de l'Île de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Statistician
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristic Pain Intensity (CPI) | From enrollement to the last evaluation (at 16 weeks after the first treatment) | 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. |
| Pain Interference | From enrollement to the last evaluation (at 16 weeks after the first treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Jaw function | From enrollement to last evaluation (at 16 weeks after the first treatment) | 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. |
| Body Pain | From enrollment to last evaluation (at 16 weeks after the first treatment) | 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. |
| Neck disability | From enrollment to last evaluation (at 16 weeks after the first treatment) | 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. |
| Jaw mobility | From enrollment to last evaluation (at 16 weeks after the first treatment) | A stainless steel ruler will be used to measure the jaw range of motion (opening, protrusion, laterotrusions). Measures will be taken in millimeters. |
| Catastrophizing | From enrollment to last evaluation (at 16 weeks after the first treatment) | 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. |
| Kinesiophobia | From enrollment to last evaluation (at 16 weeks after the first treatment) | 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. |
| Self-efficacy | From enrollment to last evaluation (at 16 weeks after the first treatment) | 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. |
| Oral Behaviors | From enrollement to last evaluation (at 16 weeks after the first treatment) | 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. |
Countries
Canada
Outcome results
None listed