PNF Exercises on Treatment of Temporomandibular Dysfunction

April 17, 2023 updated by: Marwa Shafiek Mustafa Saleh, Cairo University

Efficacy of PNF Exercises on Treatment of Temporomandibular Dysfunction in Patients With Forward Head Posture: A Double-blind, Randomized, Controlled Trial

Temporomandibular joint dysfunction (TMJD) is an important health problem that occurs approximately in 22 to 35 percent of adults, different physiotherapy methods are reported as treatment options for management of TMJD. Although that, there is no previous studies about the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture. So, the purpose of the present double-blind, randomized, controlled trial is to investigate the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture.

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.

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.
Interventional

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.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Giza, Egypt
        • marwa S saleh

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patients of both genders of age between 20-40 years
  • having symptoms of TMD for at least six weeks duration established by an expert physician or orthopaedician
  • having forward head posture with CVA < 53
  • pain over TMJ between 3 to 6 on NPRS
  • mouth opening < 25mm.

Exclusion criteria:

Patients will be excluded if they exhibited any of the following criteria:

  • TMJ fracture undergone any surgical procedure for TMJ
  • Fracture surrounding TMJ
  • Dislocation or subluxation of TMJ
  • systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases, or facial paralysis
  • recently any dental treatment is taken or surgery over TMJ
  • hematological cervical disorders which may affect the jaw
  • Neurological deficits e.g. Bells palsy, Trigeminal neuralgia.
  • Recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection
  • Participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study
  • DDwR, DDwoR
  • Patients were excluded from the study if they were receiving any other form of treatment for their TMJ dysfunction.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: control group
Other: traditional physical therapy treatment
  • Ultrasound: Continuous ultrasound at 1MHZ to temporomandibular joint at 1.0-1.25 W/CM2 for 5 min over each affected TMJ and masseter area, with the mouth in a slightly open position.
  • Forward head posture correction exercises including: chin tuck exercise, Strengthening shoulder retractors, stretching of sternocleidomastoid muscle, and Stretching of pectoralis muscle.
Experimental: study group
Other: proprioceptive neuromuscular facilitation exercises
PNF exercises will be done for Masseter, Temporalis, Lateral pterygoid and medial pterygoid muscles. Each contraction will be held for 10 seconds, and each stretch (relaxation phase) will be allowed to continue as long as the muscle tension continued to give away.

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
Pressure Pain Threshold
Time Frame: change from base line at 6 weeks.
A pressure algometer will be used for the objective measurement of the PPT. The algometer was pressed on the masseter, temporalis muscles until the patient feel pain. The unit of measurement will be in kg/cm2, and three measurements will be taken every 30 seconds. The average of the three consecutive measurements will be taken as the final value.
change from base line at 6 weeks.

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
ROM assessment
Time Frame: change from base line at 6 weeks.
A caliper will be used to measure mandibular depression, protrusion and lateral deviation.
change from base line at 6 weeks.
Temporomandibular Disorder Disability Questionnaire
Time Frame: change from base line at 6 weeks.

This questionnaire consists of the following:

  • The Temporomandibular Disorder Disability Index. It consists of 10 questions with 5 possible answers, rating a 0 to 4 score level for each of the answers.
  • The Temporomandibular Disorder symptom intensity scale and the Temporomandibular Disorder symptom frequency scale are two visual analogue scales which address the frequency and intensity of a patient's TMJ symptoms and consist of 7 sections for each scale where the patient must rate his/her intensity and frequency of symptoms on a scale of 0 to 10 score level.
  • The Pain Drawing sheet is used by the patients to capture pain location and quality.
change from base line at 6 weeks.
Numerical Rating Scale (NRS)
Time Frame: change from baseline at 6 weeks.
The patient will be asked to indicate a number between 0 and 100 on a horizontal line, that best described his/her perceived level of pain intensity when it is at its worst and when it is at is least. The average of these two totals indicates the average pain experienced by the patient as a percentage.
change from baseline at 6 weeks.

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.
Cairo 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 25, 2023

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.
March 25, 2023

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.
April 15, 2023

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).
January 21, 2023

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.
January 21, 2023

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.
February 2, 2023

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.
April 18, 2023

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 17, 2023

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, 2023

More Information

Terms related to this study

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.
  • PNF exercises for TMJ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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