Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:42 PM
Study NCT ID:
NCT07423234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Education, Self-management and Physiotherapy for Chronic Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010353', 'term': 'Patient Education as Topic'}, {'id': 'D000073278', 'term': 'Self-Management'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Statistician'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Central sensitization', 'timeFrame': 'From enrollment to last evaluation (at 16 weeks after the first treatment)', 'description': '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.'}, {'measure': 'Central sensitization', 'timeFrame': 'From enrollment to last evaluation (at 16 weeks after the first treatment)', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Characteristic Pain Intensity (CPI)', 'timeFrame': 'From enrollement to the last evaluation (at 16 weeks after the first treatment)', 'description': "Graded Chronic Pain Scale (version 2.0). This scale measures two subscales : the Characteristic Pain Intensity (CPI) and the Pain Interference.\n\nCPI 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."}, {'measure': 'Pain Interference', 'timeFrame': 'From enrollement to the last evaluation (at 16 weeks after the first treatment)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Jaw function', 'timeFrame': 'From enrollement to last evaluation (at 16 weeks after the first treatment)', 'description': '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.'}, {'measure': 'Body Pain', 'timeFrame': 'From enrollment to last evaluation (at 16 weeks after the first treatment)', 'description': '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.'}, {'measure': 'Neck disability', 'timeFrame': 'From enrollment to last evaluation (at 16 weeks after the first treatment)', 'description': '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.'}, {'measure': 'Jaw mobility', 'timeFrame': 'From enrollment to last evaluation (at 16 weeks after the first treatment)', 'description': 'A stainless steel ruler will be used to measure the jaw range of motion (opening, protrusion, laterotrusions). Measures will be taken in millimeters.'}, {'measure': 'Catastrophizing', 'timeFrame': 'From enrollment to last evaluation (at 16 weeks after the first treatment)', 'description': '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.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'From enrollment to last evaluation (at 16 weeks after the first treatment)', 'description': '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.'}, {'measure': 'Self-efficacy', 'timeFrame': 'From enrollment to last evaluation (at 16 weeks after the first treatment)', 'description': '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.'}, {'measure': 'Oral Behaviors', 'timeFrame': 'From enrollement to last evaluation (at 16 weeks after the first treatment)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporomandibular Disorders', 'Patient education', 'Self-management', 'Chronic pain', 'Randomized controlled trial', 'Pain management'], 'conditions': ['Temporomandibular Disorder (TMD)', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n1. Does an education and self-management exercise program reduce jaw pain, improve jaw function and reduce how much pain interferes with daily activities?\n2. Does this program improve outcomes similarly to the usual treatment for TMDs, which includes also manual therapy and supervised exercise sessions?\n\nResearchers 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.\n\nParticipants will:\n\nAttend three evaluation visits (at the start of the study, after 6 weeks, and after 16 weeks);\n\nBe assigned to one of two treatment groups:\n\n1. A group receiving two physiotherapy-supervised education and self-management sessions with personalized home exercises; or\n2. A group receiving six physiotherapy usual treatment sessions, which may include education, exercises, and hands-on therapy;\n\nParticipants will complete questionnaires about:\n\nJaw pain, Jaw function, Body pain, Neck disability, Oral behaviors, Pain catastrophizing, Fear of movement, Confidence in managing pain.\n\nMeasures of mouth opening will be taken (non-painful, maximal and maximal with assistance) with a ruler at all time points.\n\nThis study includes adults aged 18 to 65 years who have jaw pain for at least 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic of painful TMD according to axis 1 of DC/TMD\n* Experiencing rest pain for at least 3 months\n* With a minimum pain intensity of 3 on a 10-point Numeric Pain Rating Scale (NPRS)\n\nExclusion Criteria:\n\n* History of jaw surgery\n* Recent trauma to head or jaw\n* Ongoing dental treatment\n* History of rheumatologic condition\n* Severe psychiatric condition (e.g severe anxiety or severe depression)'}, 'identificationModule': {'nctId': 'NCT07423234', 'briefTitle': 'Patient Education, Self-management and Physiotherapy for Chronic Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': "Ciusss de L'Est de l'Île de Montréal"}, 'officialTitle': 'Patient Education, Self-management and Physiotherapy in the Management of Chronic Painful Temporomandibular Disorders : a Two-arm Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-3822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient education and self-management', 'description': "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.", 'interventionNames': ['Behavioral: Patient education and self-management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual treatment', 'description': "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.", 'interventionNames': ['Procedure: Usual treatment (multimodal)']}], 'interventions': [{'name': 'Patient education and self-management', 'type': 'BEHAVIORAL', 'description': '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.\n\nParticipants 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.\n\nEach 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.', 'armGroupLabels': ['Patient education and self-management']}, {'name': 'Usual treatment (multimodal)', 'type': 'PROCEDURE', 'description': 'Usual care consists of a comprehensive physiotherapy program commonly used for adults with temporomandibular disorders (TMD). Treatment is delivered by a trained physiotherapist.\n\nInterventions 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).\n\nParticipants will receive the same written booklet as the education and self-management arm.', 'armGroupLabels': ['Usual treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Maisonneuve-Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': '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.\n\nThe full study protocol, data dictionary, and statistical analysis plan will also be available upon request.\n\nData will be shared in a de-identified format and in accordance with ethical approvals and applicable privacy regulations.', 'accessCriteria': '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.\n\nShared 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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ciusss de L'Est de l'Île de Montréal", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Researcher, Ph.D', 'investigatorFullName': 'François Desmeules', 'investigatorAffiliation': "Ciusss de L'Est de l'Île de Montréal"}}}}