NCT06141863

Brief Summary

Cervical spine problems are associated with temporomandibular joint (TMJ) and related muscles.The aim of the present study was to investigate temporomandibular joint dysfunction (TMD) and pain in individuals with cervical disc herniation (CDH) according to the level of neck disability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 15, 2023

Last Update Submit

November 20, 2023

Conditions

Keywords

Temporomandibular Joint Dysfunction SyndromeIntervertebral Disc DisplacementDisabilityNeckJaw

Outcome Measures

Primary Outcomes (2)

  • Neck Disability Index

    Assessment of neck disability

    one day assessment

  • Fonseca Anamnestic Index

    Assessment of temporomandibular dysfunction

    one day assessment

Secondary Outcomes (1)

  • Visual Analogue Scale

    one day assessment

Study Arms (2)

Group 1

no disability and mild disability

Other: questionnaire

Group 2

moderate and severe disability

Other: questionnaire

Interventions

Neck Disability Index, The Fonseca Anamnestic Index (FAI) and Visual Analogue Scale (VAS)

Group 1Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with cervical disc herniation. Patients who were referred to physiotherapy after diagnosis were evaluated in terms of study suitability before starting treatment. We divided the participants into two groups based on their level of neck disability to compare their TMD.

You may qualify if:

  • Diagnosed with cervical disc herniation aged between 18 and 65,
  • who could read and write in Turkish

You may not qualify if:

  • Individuals with a history of head and neck surgery, fracture, physiotherapy or medical treatment cervical or temporomandibular joint treatment within the last six months,
  • presence of any inflammatory rheumatic diseases, such as ankylosing spondylitis and rheumatoid arthritis, facial paralysis, infection, advanced osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, 61000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction SyndromeIntervertebral Disc Displacement

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Temporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic DiseasesSpinal DiseasesBone DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Turgay Altunalan, Assist Prof

    Karadeniz Technical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Professor

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

May 1, 2022

Primary Completion

November 30, 2022

Study Completion

December 30, 2022

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations