Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals With Temporomandibular Dysfunction

Sponsor
Karadeniz Technical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05993494
Collaborator
(none)
90
1
8.5
10.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Investigation of the Relationship Between Pain, Central Sensitization, Kinesiophobia and Stress Level in Individuals With Temporomandibular Dysfunction
    Actual Study Start Date :
    May 15, 2023
    Anticipated Primary Completion Date :
    Dec 30, 2023
    Anticipated Study Completion Date :
    Jan 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Numeric Pain Scale [through study completion, an average of 1 year]

      Pain Assessment

    2. Tampa Scale for Kinesiophobia [through study completion, an average of 1 year]

      Kinesiophobia Assessment for temporomandibular joint dysfunction

    3. Perceived Stress Scale [through study completion, an average of 1 year]

      Stress Assessment

    4. Central sensitization scale [through study completion, an average of 1 year]

      Central sensitization Assessment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Between the ages of 18-65,

    • Having complaints related to TMJ for at least 3 months,

    • Patients diagnosed with TMD as a result of clinical and radiological evaluation by the dentist

    Exclusion Criteria:
    • Cognitive problems,

    • Any systemic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),

    • Serious systemic diseases,

    • Any neurological disorder (e.g. trigeminal neuralgia),

    • Pregnancy, breastfeeding status,

    • Previous treatment for TMJ or orofacial muscle pain

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karadeniz Technical University Trabzon Turkey 61000

    Sponsors and Collaborators

    • Karadeniz Technical University

    Investigators

    • Principal Investigator: Nurhayat Korkmaz, Karadeniz Technical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nurhayat KORKMAZ, Research assistant, Karadeniz Technical University
    ClinicalTrials.gov Identifier:
    NCT05993494
    Other Study ID Numbers:
    • KTU-FTR-2023/6
    First Posted:
    Aug 15, 2023
    Last Update Posted:
    Aug 15, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nurhayat KORKMAZ, Research assistant, Karadeniz Technical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 15, 2023