Proprioceptive Neuromuscular Facilitation Exercises in Temporomandibular Dysfunction

April 28, 2025 updated by: gizem ergezen, Istanbul Medipol University Hospital

The Immediate Effect of Proprioceptive Neuromuscular Facilitation on Pain and Maximal Mouth Opening in Temporomandibular Dysfunction: Pilot Study

Individuals who were diagnosed with reduction disc displacement by Research Diagnostic criteria for Temporomandibular Disorder (TMD / RDC) were included in the study. Proprioceptive neuromuscular facilitation exercises were performed for 30 minutes using neck jaw and tongue patterns with rhythmic stabilization (RS) and combination of isotonics (CI) techniques by physiotherapist. Maximal mouth openings were measured with caliper, pain intensities were measured with visual analogue scale and pressure pain thresholds with hand algometer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

TMD patients who are diagnosed by TMD/RDC are firstly assessed by physiotherapist for maximal mouth opening(MMO), pain intensity and pressure pain threshold. Then they will taught exercises with rhythmic initiation which includes repetation of the patern and 15 repetitions are applied as warm-up period. Proprioceptive neuromuscular facilitation (PNF) exercises are performed in the neck and jaw patterns with rhythmic stabilization (RS) and combination of isotonics (CI) techniques. In the neck, right rotation-right lateral flexion, left rotation-left lateral flexion pattern, and the opening and closing pattern according to the working mechanics of the masseter and temporal muscle in the chin, RS and CI techniques are used. By providing maximum resistance in accordance with the needs of each individual, the RS protocol consist of isometric contractions that would not involve changing movements for 10 seconds. The combination of isotonics technique include combined concentric, isometric, and eccentric contraction of the agonist muscle for 5 seconds of each contraction without rest. CI exercises consist of 15 repetitions per set. A 30-second rest given between sets to include recovery. After exercises immediate MMO, pain intensity and pain treshold assessment will be applied.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Beykoz
      • Istanbul, Beykoz, Turkey, 34810
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

University students

Description

Inclusion Criteria:

  • Volunteers between 18-25 years female, admitted to the study with clenching, grinding, clicking, jaw pain when eating hard foods, and limited and painful mouth movements.

Exclusion Criteria:

  • Having orthopedic, neurological or rheumatological cervical disorders which affect the jaw motions; receiving occlusal therapy as a companion to treatment, those who have an operation in the area of jaw, head and neck and those with vertigo that prevents head movements during exercises.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PNF group
Proprioceptive Neuromuscular Fascilitation exercises were given this group
Other: PNF exercises
PNF exercises were applied in 3 sets of 15 repetitions based on movement in the diagonal plane, using head, neck and chin patterns. Contractions were sustained for at least 10 seconds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Treshold
Time Frame: the immediate effect will be measured as soon as the exercise is finished
The pain threshold will be measured with an algometer at certain points on the muscles in the area where the exercise is applied.
the immediate effect will be measured as soon as the exercise is finished
Pain intensity
Time Frame: the immediate effect will be measured as soon as the exercise is finished
The level of pain felt will be marked with a visual analog scale on a 10-centimeter paper.
the immediate effect will be measured as soon as the exercise is finished
Maximum mouth opening
Time Frame: the immediate effect will be measured as soon as the exercise is finished
Individuals will be asked to open their mouths as much as they can, and mouth opening will be measured with a caliper.
the immediate effect will be measured as soon as the exercise is finished

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Unassisted opening
Time Frame: the immediate effect will be measured as soon as the exercise is finished
the individual is told to open their mouth and the gap is measured with a caliper.
the immediate effect will be measured as soon as the exercise is finished
maximum unassisted opening
Time Frame: the immediate effect will be measured as soon as the exercise is finished
Without trying to increase the mouth opening with hand or any help, the individual actively opens mouth as much as they can and the opening is measured with a caliper.
the immediate effect will be measured as soon as the exercise is finished
maximum assisted opening
Time Frame: the immediate effect will be measured as soon as the exercise is finished
It is measured with a caliper by asking individuals to open their mouths as much as they can and open more by helping with their hands at the last point.
the immediate effect will be measured as soon as the exercise is finished

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Esra Atılgan, PhD, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10840098-604.01.01-E.60748

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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