Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 10:52 AM
Study NCT ID:
NCT05993494
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2023-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals With Temporomandibular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2023-07-30', 'studyFirstSubmitQcDate': '2023-08-14', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Scale', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Pain Assessment'}, {'measure': 'Tampa Scale for Kinesiophobia', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Kinesiophobia Assessment for temporomandibular joint dysfunction'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Stress Assessment'}, {'measure': 'Central sensitization scale', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Central sensitization Assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporomandibular Joint Dysfunction', 'Pain', 'central sensitization', 'kinesiophobia', 'stress'], 'conditions': ['Temporomandibular Joint Disorders', 'Pain']}, 'descriptionModule': {'briefSummary': 'Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Recent research has focused specifically on pain catastrophe, kinesiophobia, and central sensitization in individuals with TMD. Therefore, the aim of this study is to examine the relationship between pain, central sensitization, kinesiophobia and stress level in individuals with temporomandibular dysfunction.', 'detailedDescription': 'Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Psychological factors are stated as comorbid in individuals with TMD. Individuals with TMD-related pain show higher levels of stress, anxiety, depression, somatic awareness, pain catastrophizing, and kinesiophobia compared to controls. Therefore, recent research has focused on pain catastrophe, kinesiophobia, and central sensitization, especially in individuals with TMD. Therefore, the aim of this study is to examine the relationship between pain, central sensitization, kinesiophobia and stress level in individuals with temporomandibular dysfunction. Ninety patients aged 18-65 years, who have TME-related complaints for at least 3 months, and diagnosed with TMD as a result of clinical and radiological evaluation by a dentist will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '-Patients diagnosed with Temporomandibular joint disorders', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-65,\n* Having complaints related to TMJ for at least 3 months,\n* Patients diagnosed with TMD as a result of clinical and radiological evaluation by the dentist\n\nExclusion Criteria:\n\n* Cognitive problems,\n* Any systemic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),\n* Serious systemic diseases,\n* Any neurological disorder (e.g. trigeminal neuralgia),\n* Pregnancy, breastfeeding status,\n* Previous treatment for TMJ or orofacial muscle pain'}, 'identificationModule': {'nctId': 'NCT05993494', 'briefTitle': 'Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals With Temporomandibular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Investigation of the Relationship Between Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals With Temporomandibular Dysfunction', 'orgStudyIdInfo': {'id': 'KTU-FTR-2023/6'}}, 'contactsLocationsModule': {'locations': [{'zip': '61000', 'city': 'Trabzon', 'state': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Karadeniz Technical University', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'overallOfficials': [{'name': 'Nurhayat Korkmaz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karadeniz Technical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Nurhayat KORKMAZ', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}