NCT05420896

Brief Summary

Individuals with temporomandibular joint dysfunction (TMD) may experience changes in muscle activation as a result of symptoms such as pain and limitation of movement. The aim of this study is to examine the efficacy of manual therapy electromyographically in patients with TMD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

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

June 10, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

June 13, 2022

Last Update Submit

February 20, 2023

Conditions

Keywords

temporomandibular joint dysfunctionmanual therapyEMGmaximal mouth opening

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.

    Change from initial assessment to 4 weeks after initial assessment.

Secondary Outcomes (6)

  • Electromyography (EMG)

    Change from initial assessment to 4 weeks after initial assessment.

  • Pain Pressure Threshold (PPT)

    Change from initial assessment to 4 weeks after initial assessment.

  • Maximum Mouth Opening (MMO)

    Change from initial assessment to 4 weeks after initial assessment.

  • TAMPA

    Change from initial assessment to 4 weeks after initial assessment.

  • Functional Limitation Scale of the Jaw-8

    Change from initial assessment to 4 weeks after initial assessment.

  • +1 more secondary outcomes

Study Arms (2)

Manual therapy

ACTIVE COMPARATOR

Upper cervical spine mobilization Posterior-anterior mobilization of the fifth cervical vertebra Suboccipital inhibition Suboccipital mobilization Trigger point application to my masseter, temporal and sternocleidomastoid muscles Intraoral and extraoral myofascial release Intraoral sphenopalatine ganglion technique TMJ mobilization Massage for chewing muscles The 45-minute treatment program, which includes applications including the techniques above, will be applied to the patients randomly assigned to the study group once a week for a total of 4 weeks.The changes in muscle activity of the masseter and anterior temporalis bilaterally will be recorded with EMG.

Other: Manual Therapy

Control group

NO INTERVENTION

Patients assigned to the control group randomly will be re-evaluated 4 weeks after their initial evaluation. No intervention will be applied during this period. After 4 weeks, when the patients are re-evaluated, they will be directed to the appropriate treatment.

Interventions

Upper cervical spine mobilization Posterior-anterior mobilization of the fifth cervical vertebra Suboccipital inhibition Suboccipital mobilization Trigger point application to my masseter, temporal and sternocleidomastoid muscles Intraoral and extraoral myofascial release Intraoral sphenopalatine ganglion technique TMJ mobilization Massage for chewing muscles The 45-minute treatment program, which includes applications including the techniques above, will be applied to the patients randomly assigned to the study group once a week for a total of 4 weeks.The changes in muscle activity of the masseter and anterior temporalis bilaterally will be recorded with EMG.

Manual therapy

Eligibility Criteria

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

You may qualify if:

  • No cognitive impairment
  • Diagnosed with temporomandibular joint(TMJ) dysfunction of myofascial origin,
  • Volunteers aged 18-65

You may not qualify if:

  • Malignancy and fracture of the cervical region and/or TMJ
  • Active infection
  • Patients actively receiving cervical and/or TMJ-related therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahçeşehir University

Istanbul, Europe, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Kumru Ateş, PhC

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR

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
PhD-C

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 15, 2022

Study Start

June 10, 2021

Primary Completion

September 5, 2022

Study Completion

November 10, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations