NCT06526845

Brief Summary

Telerehabilitation is a treatment method that allows the patient to access treatment remotely, regardless of where they are, thanks to developing technology. Telerehabilitation provides us with opportunities such as patient evaluation, monitoring, therapy, consultation, education and patient follow-up. Within the scope of our study, the effects of applying an exercise program to patients through a home exercise program and telerehabilitation will be investigated. The purpose of this study for individuals with temporomandibular joint dysfunction is; To investigate the effectiveness of exercises for myofascial pain through telerehabilitation in individuals with myofascial pain and TMJ dysfunction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

July 17, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 17, 2024

Last Update Submit

July 24, 2024

Conditions

Keywords

Temporomandibular Joint DisordersTelerehabilitationExercise

Outcome Measures

Primary Outcomes (7)

  • Fonseca Anamnestic Index

    Temporomandibular dysfunction is assessed using the Fonseca Anamnestic Index .

    Change from Fonseca Anamnestic Index at 6 weeks.

  • Visual Analogue Scale

    Participants; It is performed to evaluate jaw and facial pain when waking up in the morning, during the day, at bedtime, when chewing and at rest. Visual Analogue Scale includes scoring between 0-10. The minimum value is 0 score - no pain; The maximum score of 10 indicates unbearable pain. A higher score means more pain and a worse outcome.

    Change from Visual Analog Scale at 6 weeks.

  • Painless Maximum Mouth Opening

    It will be done to evaluate the painless maximum mouth opening of the participants. It will be performed to evaluate the pain-free maximum mouth opening of the participants. The patient will be asked to open his mouth as far as possible and the distance between the lower and upper incisors will be measured with a millimeter ruler. The result will be recorded in mm.

    Change from Painless Maximum Mouth Opening at 6 weeks.

  • Painful Maximum Mouth Opening

    It will be performed to evaluate the participants' maximum mouth opening with pain. The patient will be asked to open his mouth to the last painful point and the distance between the lower and upper incisors will be measured with a millimeter ruler. The result will be recorded in mm.

    Change from Painful Maximum Mouth Opening at 6 weeks.

  • Maximum Mouth Opening With Passive Assistance

    It will be carried out to evaluate the maximum mouth opening of the participants with passive assistance (dentist or physiotherapist). The patient will be asked to open his mouth as far as possible with the support of a dentist or physiotherapist, and the distance between the lower and upper incisors will be measured with a millimeter ruler. The result will be recorded in mm.

    Change from Maximum Mouth Opening With Passive Assistance at 6 weeks.

  • Mandibula Lateral Shift

    It evaluates the right and left shifts of the mandibula in participants. The patient first moves his lower jaw to the right and how far it moves from the midline is measured with a millimetric ruler. The measured value is recorded in millimeters. Then, the same process is performed for the left side.

    Change from Mandibula Lateral Shift at 6 weeks.

  • Oral Health Impact Profile-14 (OHIP-14)

    It evaluates the quality of life in temporomandibular joint dysfunction. The total score varies between 0-84. A high score indicates that you have bad oral habits.

    Change from Oral Health Impact Profile-14 (OHIP-14) at 6 weeks.

Secondary Outcomes (3)

  • Oral Behaviour Checklist

    Change from Oral Behaviour Checklist at 6 weeks.

  • Cervical Region Joint Range of Motion

    Change from Cervical Region Joint Range of Motion at 6 weeks.

  • Neck Disability Index

    Change from Neck Disability Index at 6 weeks.

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

All exercises in the brochure will be performed by patients via telerehabilitation.It will be applied twice a week for 6 weeks.

Other: Video-Conference based rehabilitation

Home-Based Exercise Group

ACTIVE COMPARATOR

Patient education will be provided by showing all the exercises in practice. Then, brochures will be given to the patients so that they can practice them at home.It will be applied twice a week for 6 weeks.

Other: Home-Based rehabilitation

Interventions

All exercises in the brochure will be performed by patients via telerehabilitation. The exercises included in the exercise package are as follows: * Post-isometric relaxation exercise and relaxation exercise with diaphragmatic breathing * Neck Exercises: 5 neck exercises including cervical isometric flexion, extension, right and left lateral flexion and chin tuck exercises. * Soft tissue-friction massage: It will be applied to the area where myofascial pain develops due to TMJD. * Mandibular mobility exercises: opening and closing the mouth slowly and rhythmically, lateral movements, protrusion movement, hold-relax technique, jaw isometric exercises * Stretching exercises: Stretching exercises for chewing muscles (masseter muscle stretching, temporalis muscle stretching, pterygoid muscle stretching).

Telerehabilitation Group

Patient education will be provided by showing all exercises in practice. Brochures will then be given to patients so they can apply them at home. The exercises in the brochure are as follows; * Post-isometric relaxation exercise and relaxation exercise with diaphragmatic breathing * Neck Exercises: 5 neck exercises including cervical isometric flexion, extension, right and left lateral flexion and chin tuck exercises. * Soft tissue-friction massage: It will be applied to the area where myofascial pain develops due to TMJD. * Mandibular mobility exercises: opening and closing the mouth slowly and rhythmically, lateral movements, protrusion movement, hold-relax technique, jaw isometric exercises * Stretching exercises: Stretching exercises for chewing muscles (masseter muscle stretching, temporalis muscle stretching, pterygoid muscle stretching).

Home-Based Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People between the ages of 18-65 with myofascial temporomandibular pain
  • Displacement of the disc with anterior reduction,
  • Pain in the masticatory muscle/temporomandibular area lasting more than a month
  • Symptoms lasting at least three months,
  • People who have the opportunity to provide informed consent and participate in treatment and evaluation clinics.

You may not qualify if:

  • Anterior disc displacement without reduction,
  • Primary arthrogenic pain,
  • Other temporomandibular disorders,
  • Neurological or psychiatric disorders,
  • People who have had temporomandibular joint and/or cervical spine surgery,
  • Abuse of painkillers or abuse of existing medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buket AKINCI

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersMotor Activity

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesBehavior

Study Officials

  • Buket AKINCI, Assoc.Prof.

    Consultor

    STUDY DIRECTOR
  • Nükhet KÜTÜK, Prof.

    study chair

    STUDY CHAIR
  • Beliz SERDAROĞLU, Dt.

    study chair

    STUDY CHAIR
  • Naile FAZLIOĞLU, PT.

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Buket AKINCI, Assoc.Prof.

CONTACT

Naile Fazlıoğlu, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 30, 2024

Study Start

July 23, 2024

Primary Completion

October 30, 2024

Study Completion

December 30, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations