NCT06148818

Brief Summary

The primary aim of this study was to investigate the effects of progressive neck motor control exercises on craniocervical pain, posture, function and kinesiophobia in different types of temporomandibular dysfunction. The secondary aim of the study was to examine the differences between the effects of progressive neck motor control exercises on different types of temporomandibular dysfunction.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

November 4, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 29, 2025

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

November 20, 2023

Last Update Submit

January 27, 2025

Conditions

Keywords

Temporomandibular Joint Dysfunction SyndromePainneck motor control exerciseposturekinesiophobiafunction

Outcome Measures

Primary Outcomes (8)

  • Fonseca Anamnestic Index

    Assessment of Temporomandibular Dysfunction Severity

    1st, sixth week, first mont

  • Numeric Pain Scale

    Assessment of Pain, 0: No pain, 10: Maximum pain

    1st, sixth week, first mont

  • Pressure pain threshold

    Assessment of Pressure pain threshold

    1st, sixth week, first mont

  • Range of motion

    Assessment of Temporomandibular joint and neck range of motion

    1st, sixth week, first mont

  • Joint position error test

    Assessment of Cervical proprioception

    1st, sixth week, first mont

  • Endurance

    Assessment of Deep neck flexor endurance

    1st, sixth week, first mont

  • Photographic Posture Analysis

    Assessment of head and neck posture

    1st, sixth week, first mont

  • Mandibular Function Impairment Questionnaire

    Assessment of Mandibular Function

    1st, sixth week, first mont

Secondary Outcomes (1)

  • Tampa kinesiophobia scale

    1st, sixth week, first mont

Study Arms (6)

Myofascial

EXPERIMENTAL

Myofascial Temporomandibular Dysfunction

Other: Progressive neck motor control exercise therapyOther: Patient education

disc displacement with reduction

EXPERIMENTAL

Temporomandibular joint disc displacement with reduction

Other: Progressive neck motor control exercise therapyOther: Patient education

disc displacement without reduction

EXPERIMENTAL

Temporomandibular joint disc displacement without reduction

Other: Progressive neck motor control exercise therapyOther: Patient education

Myofascial2

OTHER

Myofascial Temporomandibular Dysfunction

Other: Patient education

disc displacement with reduction2

OTHER

Temporomandibular joint disc displacement with reduction

Other: Patient education

disc displacement without reduction2

OTHER

Temporomandibular joint disc displacement without reduction

Other: Patient education

Interventions

The exercise programme will be conducted as a single session two days a week for 6 weeks. The sessions will always be conducted by the same physiotherapist. Each exercise session will consist of 10 minutes of warm-up exercises, 40 minutes of neck motor control exercises and 10 minutes of cool down exercises. Each exercise will be performed as 2 sets of 10 repetitions.

Myofascialdisc displacement with reductiondisc displacement without reduction

The content of this education consists of information about the disease and symptoms, chewing recommendations, dietary changes, parafunctional habits, activities to be avoided, posture recommendations.

MyofascialMyofascial2disc displacement with reductiondisc displacement with reduction2disc displacement without reductiondisc displacement without reduction2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 55 years old,
  • Temporomandibular joint-related complaints for at least 3 months,
  • Temporomandibular dysfunction is diagnosed as a result of clinical and radiological evaluation by the dentist,
  • Neck pain of 3 or more according to the numeric pain scale

You may not qualify if:

  • Cognitive problems,
  • The one with the splint,
  • Those who have used painkillers or muscle relaxants for temporomandibular dysfunction complaints in the last 1 week,
  • With any systematic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),
  • Those with serious systemic diseases,
  • Any neurological disorder (e.g. trigeminal neuralgia),
  • Pregnancy or breastfeeding,
  • Treated for Temporomandibular joint or orofacial muscle pain in the last 3 months,
  • Has undergone an operation/trauma to the cervical region and/or temporomandibular joint,
  • Positive vertebrobasilar artery test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction SyndromePainKinesiophobia

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Temporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nurhayat Korkmaz, PhDstudent

    Karadeniz Technical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

nurhayat korkmaz, PhDstudent

CONTACT

Nurhayat Korkmaz, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assisstant

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

November 4, 2024

Primary Completion

May 30, 2025

Study Completion

June 30, 2025

Last Updated

January 29, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations