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

NCT07423234 | Active Not Recruiting

• 1 other identifier: 2025-3822
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 2.Does this program improve outcomes similarly to the usual treatment for TMDs, which includes also manual therapy and supervised exercise sessions?
3. 3.A group receiving two physiotherapy-supervised education and self-management sessions with personalized home exercises; or
4. 4.A group receiving six physiotherapy usual treatment sessions, which may include education, exercises, and hands-on therapy;

Conditions

Temporomandibular Disorder (TMD); Chronic Pain

Keywords

Temporomandibular Disorders; Patient education; Self-management; Chronic pain; Randomized controlled trial; Pain management

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollement to the last evaluation (at 16 weeks after the first treatment)

Secondary Outcomes (8)

• Jaw function

  From enrollement to last evaluation (at 16 weeks after the first treatment)

• Body Pain

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

• Neck disability

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

• Jaw mobility

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

• Catastrophizing

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

Other Outcomes (2)

• Central sensitization

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

• Central sensitization

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

Study Arms (2)

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.

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.

Procedure: Usual treatment (multimodal)

Interventions

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.

Patient education and 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.

Usual treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Chronic Pain; Agnosia

Interventions

Patient Education as Topic; Self-Management

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Researcher, Ph.D

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 20, 2026
• Study Start: January 16, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data and supporting documents will be available beginning 12 months after publication of the primary study results and will remain available for 5 years following publication.
• Access Criteria: Access to de-identified individual participant data and supporting documents will be granted to qualified researchers who submit a reasonable request with a clear research purpose. Requests must be sent to the corresponding author. Shared materials may include de-identified outcome data, baseline characteristics, and supporting study documents (protocol, data dictionary, and statistical analysis plan). Data will be provided in a secure electronic format following approval of the request and in accordance with ethical approvals and applicable privacy regulations.

Locations

CA (1)