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NCT Number: NCT07423234

Patient Education, Self-management and Physiotherapy for Chronic Temporomandibular Disorders

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Temporomandibular Disorder (TMD) Agnosia Chronic Pain Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T2M4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Patient education and self-management

Behavioral

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

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.

Primary outcomes

  1. Characteristic Pain Intensity (CPI)

    Time frame: 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.

  2. Pain Interference

    Time frame: 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 outcomes

  1. Jaw function

    Time frame: 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.

  2. Body Pain

    Time frame: 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.

  3. Neck disability

    Time frame: 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.

  4. Jaw mobility

    Time frame: 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.

  5. Catastrophizing

    Time frame: 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.

  6. Kinesiophobia

    Time frame: 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.

  7. Self-efficacy

    Time frame: 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.

  8. Oral Behaviors

    Time frame: 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.

Other outcomes

  1. Central sensitization

    Time frame: From enrollment to last evaluation (at 16 weeks after the first treatment)

    Pain drawings will be completed by participants using a pen on paper method (round nib 1.5 mm) on body charts from axis II of the DC/TMD (body, face and jaw). The extent of body pain will be computer-analyzed.

  2. Central sensitization

    Time frame: From enrollment to last evaluation (at 16 weeks after the first treatment)

    Central Sensitization Inventory (CSI). The CSI consists of 25 items assessing symptoms of central sensitization, rated on a 5-point Likert scale (0=Never, 4=Always), totaling 0-100. A score of 40 or higher indicates the likely presence of a Central Sensitization Syndrome (CSS), with higher scores representing greater symptom severity.

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Registry information

Official study title

Patient Education, Self-management and Physiotherapy in the Management of Chronic Painful Temporomandibular Disorders : a Two-arm Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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