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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06148818
Other study ID # 2023/15
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date February 20, 2025

Study information

Verified date March 2024
Source Karadeniz Technical University
Contact nurhayat korkmaz, PhDstudent
Phone +90538736
Email krkmznrhyt@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

In this randomised controlled study, the effects of progressive neck motor control exercise therapy on craniocervical pain, posture, function and kinesiophobia in individuals with different types of temporomandibular dysfunction (myofascial, disc displacement with reduction, disc displacement without reduction) and their differences with the control group will be compared. Participants diagnosed by a dentist according to three different types of temporomandibular dysfunction will be included in the study. Participants will be divided into groups by block randomisation method. A total of 6 groups will be included in the study, including participants with three different types of temporomandibular dysfunction who voluntarily agree to participate in the study and meet the inclusion criteria, and the control group of each group. The study groups will receive the same treatment and patient education for 6 weeks, while the control groups will receive only patient education.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date February 20, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - 18 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms

  • Joint Diseases
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
Progressive neck motor control exercise therapy
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.
Patient education
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.

Locations

Country Name City State
Turkey Karadeniz Technical University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fonseca Anamnestic Index Assessment of Temporomandibular Dysfunction Severity 1st, sixth week, first mont
Primary Numeric Pain Scale Assessment of Pain, 0: No pain, 10: Maximum pain 1st, sixth week, first mont
Primary Pressure pain threshold Assessment of Pressure pain threshold 1st, sixth week, first mont
Primary Range of motion Assessment of Temporomandibular joint and neck range of motion 1st, sixth week, first mont
Primary Joint position error test Assessment of Cervical proprioception 1st, sixth week, first mont
Primary Endurance Assessment of Deep neck flexor endurance 1st, sixth week, first mont
Primary Photographic Posture Analysis Assessment of head and neck posture 1st, sixth week, first mont
Primary Mandibular Function Impairment Questionnaire Assessment of Mandibular Function 1st, sixth week, first mont
Secondary Tampa kinesiophobia scale Assessment of kinesiophobia for temporomandibular joint, 12 points: low kinesiophobia; 48 points:high kinesiophobia 1st, sixth week, first mont
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