Adding Core Stabilization Training to Manuel Therapy in Temporomandibular Disorders

November 2, 2022 updated by: Marmara University

Adding Core Stabilization Training to Orofacial Manuel Therapy in Individuals With Temporomandibular Disorders: A Randomized Controlled Study

Primary aim of this study is to determine whether core stabilization training in addition to orofacial manual therapy is more effective on Temporomandibular Disorders (TMD) symptoms than orofacial manual therapy alone in patients with TMD. These secondary aim is to determine the effectiveness of orofacial manual therapy on TMD symptoms in patients with TMD. Patients will be treated for 10 sessions once a week, for a total of 10 weeks. Evaluation was planned to be done twice, at the beginning and end of the treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary aim of this study is to determine whether core stabilization training in addition to orofacial manual therapy is more effective on Temporomandibular Disorders (TMD) symptoms than orofacial manual therapy alone in patients with TMD. These secondary aim is to determine the effectiveness of orofacial manual therapy on TMD symptoms in patients with TMD. The patients to be included in the study will be randomly divided into three groups and it is planned to include 15 people in each group. Home exercises and patient education will be provided to all patients.

  • Group 1 (CST group): Orofacial manual therapy + core stabilization training (CST) + home exercise and patient education
  • Group 2 (OMT group): Orofacial manual therapy (OMT) + home exercise and patient education
  • Group 3 (Control group): Home exercise and patient education.

Pain intensity, pressure pain threshold, joint range of motion, posture, flexibility, stabilization of core muscles, functionality and sleep quality will be evaluated by using Visual Analog Scale (VAS), digital algometer, ruler, Palpation Meter (PALM), bubble inclinometer, tape measure, Finger-to-floor distance (EPZM) and sit-reach test, pressure biofeedback unit, "Helkimo Index", "Pittsburgh Sleep Quality Index (PUKI)" respectively. Patients will be treated for 10 sessions once a week, for a total of 10 weeks. Evaluation was planned to be done twice, at the beginning and end of the treatment.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • 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 Contact

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

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteered to participate,
  • Aged between 18-60 years old,
  • Having the diagnosis of Temporomandibular Disorders (TMB),

Exclusion Criteria:

  • Having a malignant condition, trauma and surgery of the cranial and cervical region,
  • Not being cooperative,
  • Regular use of analgesic and anti-inflammatory drugs,
  • Having dentofacial anomalies,
  • Having active inflammatory arthritis,
  • Having lumbal pathology,
  • Having metabolic diseases (Gout, osteoporosis, Cushing's disease and hyper/hypo-parathyroidism),
  • Having connective tissue, rheumatological (Systemic lupus erythematosus and scleroderma) and hematological disorders (Anemia and leukemia),
  • Having a diagnosed psychiatric illness,
  • Receiving TMD-related physical therapy less than 6 months ago

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CST Group
The core stabilization group. Participants in this group will be received core stabilization training, orofacial manuel therapy and conventional physiotherapy (Home exercise program and patient education) as treatment. The number of participants is planned to be 15.
Other: Core Stabilization Training
Core Stabilization training will be based on dynamic neuromuscular stabilization and consists of three stages. In the first session, it is to teach the simultaneous activation of the transversus abdominis, pelvic floor, multifidus and diaphragm muscles and to improve muscle coordination and proprioception in the entire spinal region. In the second and third phases, exercises will be made more intense to improve muscular endurance and stability. The difficulty of the exercises will be increased by working in different positions, using resistance bands, exercise balls and body weight, and adding movements to the extremities. A total of 10 sessions of treatment program will be applied to the patients for ten weeks, once a week.
Other: Orofacial Manual Therapy
As orofacial manual therapy, soft tissue (intraoral and extraoral trigger point therapy and myofascial release of painful muscles) and joint mobilization (caudal and ventro-caudal traction, ventral and mediolateral translation), muscle energy technique, fascia mandibularis release, occipital release and ligamentous treatment was planned.
Other: Conventional Physiotherapy
Conventional physiotherapy consists of home exercise and patient education. Patient education consists of parafunctional behaviors, habits, a diet with soft food, and posture education. The exercises consist of exercises for the mandible, cervical and thoracic region and breathing. All movements are planned to be done at home 3 times a day, every day of the week.
Experimental: OMT Group
The orofacial manuel therapy group. Participants in this group will be received orofacial manuel therapy and conventional physiotherapy (Home exercise program and patient education) as treatment. The number of participants is planned to be 15.
Other: Orofacial Manual Therapy
As orofacial manual therapy, soft tissue (intraoral and extraoral trigger point therapy and myofascial release of painful muscles) and joint mobilization (caudal and ventro-caudal traction, ventral and mediolateral translation), muscle energy technique, fascia mandibularis release, occipital release and ligamentous treatment was planned.
Other: Conventional Physiotherapy
Conventional physiotherapy consists of home exercise and patient education. Patient education consists of parafunctional behaviors, habits, a diet with soft food, and posture education. The exercises consist of exercises for the mandible, cervical and thoracic region and breathing. All movements are planned to be done at home 3 times a day, every day of the week.
Experimental: Control Group
Participants in this group will be received only conventional physiotherapy (Home exercise program and patient education) as treatment. The number of participants is planned to be 15.
Other: Conventional Physiotherapy
Conventional physiotherapy consists of home exercise and patient education. Patient education consists of parafunctional behaviors, habits, a diet with soft food, and posture education. The exercises consist of exercises for the mandible, cervical and thoracic region and breathing. All movements are planned to be done at home 3 times a day, every day of the week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain severity: VAS
Time Frame: Change from Baseline pain severity at 10 weeks.
Pain will be defined with Visual Analog Scale (VAS). A 10-cm long horizontal visual analog scale (VAS) with marks 0 point (no pain) and 10 point (unbearable pain) will be used for evaluating the pain severity. The patients will be asked to mark the representing point of their pain levels. The values will be recorded in cm. In the study, the pain felt by the patients at rest, at maximum mouth opening and during clenching will be evaluated separately according to this scale.
Change from Baseline pain severity at 10 weeks.
Pain Threshold: Digital algometer
Time Frame: Change from Baseline pain threshold at 10 weeks.
The algometer is a reliable instrument for measuring the sensitivity of the masticatory muscles. The measurement will be made at 8 points. A force (Newton in force) of 1 kg (weight in kilogram) per square centimeter (surface area in centimeter square) is applied to the patient for 3 seconds, and this is continued until the patient feels pain (weight and surface area will be combined to report Newton in kg/ cm2). The physiotherapist will passively support the individual's head with the other hand. This process will be repeated three times and the average value will be calculated.
Change from Baseline pain threshold at 10 weeks.
Range of Motion
Time Frame: Change from Baseline range of motion at 10 weeks.
Mouth opening, protrusion and right and left lateral deviation will be measured starting from 0 using a 15 cm ruler. Repeated measuring reduces the standard error of measurement, hence repeated measurements were also included in our study (three times) with the largest recorded range taken.
Change from Baseline range of motion at 10 weeks.
Facial asymmetry
Time Frame: Change from Baseline facial asymmetry at 10 weeks.
For facial asymmetry evaluation, the distance between the anterior notch of the chin and the mandible line will be measured with a tape measure.
Change from Baseline facial asymmetry at 10 weeks.
Degree of pelvic tilt
Time Frame: Change from Baseline degree of pelvic tilt at 10 weeks.
Palpation Meter (PALM), (Salt Lake City, United Kingdom, USA) will be used for pelvic tilt evaluation. The Palpation Meter has an angle inclinometer and two 360-swivel arms, one of arms will be placed in the Spina iliaca Anterior Superior (SIAS) and the other in the Spina iliaca Posterior Superior (SIPS). In this position, the angle indicated by the inclinometer will be recorded as the pelvic tilt angle.
Change from Baseline degree of pelvic tilt at 10 weeks.
Degree of lordosis
Time Frame: Change from Baseline degree of lordosis at 10 weeks.
Bubble inclinometer (White Plains, New York 10602 USA) will be used for lumbar lordosis evaluation. The degree of lordosis will be determined by measuring the spinous processes of the T12-L1 and S2-3 vertebrae with a bubble inclinometer and adding the degrees found.
Change from Baseline degree of lordosis at 10 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flexibility of lumbal extensor muscles
Time Frame: Change from Baseline Finger-to-floor distance (EPZM) at 10 weeks.
Finger-to-floor distance (EPZM) will be used for flexibility of lumbal extensor. In the EPZM test, individuals will stand on a stool and are asked to bend their torso forward to reach as far as possible with both hands without bending the knees. The distance between the stool level and the middle finger will be measured by the therapist and and this distance will be recorded in cm. The individual will be asked to repeat this movement three times and the highest value will be taken as the test score.
Change from Baseline Finger-to-floor distance (EPZM) at 10 weeks.
Flexibility of hamstring muscles
Time Frame: Change from Baseline sit-reach test at 10 weeks.
Sit-reach test will be used for flexibility of hamstring muscles. For the sit-and-reach test, the individual will be seated without shoes in a long sitting position on the floor, with his feet propped on a 30 cm bench that is scaled by dividing the top into cm. The body will be asked to lie forward on the coffee table as much as possible without bending the knees, wait 2 seconds at the extreme point where the fingers are extended, and this distance will be recorded in cm. The individual will be asked to repeat this movement three times and the highest value will be taken as the test score.
Change from Baseline sit-reach test at 10 weeks.
Performance of stabilizer muscles
Time Frame: Change from Baseline lumbopelvic stabilization at 10 weeks.
Lumbopelvic stabilization will be assessed using a pressure biofeedback unit (Stabilizer Pressure Biofeedback Unit, Chattanooga Group Inc., Hixson, Tennessee, USA). Individuals will be asked to lie on their back in a hooked position. The pressure cell of the instrument will be placed under the lumbar vertebrae. The subjects will be asked to perform the abdominal drawing-in maneuver as previously taught, with no spinal or pelvic movement. The change in pressure will be recorded in mmHg and the time that the contraction can be maintained in seconds.
Change from Baseline lumbopelvic stabilization at 10 weeks.
Functionality
Time Frame: Change from Baseline Helkimo Index at 10 weeks.
"Helkimo Index" will be used to evaluate Temporomandibular Joint (TMJ) pain and dysfunction. This index evaluates the clinical dysfunction of the stomatognathic system based on the 5 signs of TMD. Pain during mandible movement, TMJ pain, pain in masticatory muscles, TMJ sound and maximum mouth opening are evaluated with different questions between 0-5. The total dysfunction score ranges from 0 to 25. 0 no dysfunction; Values 1-4 are mild dysfunction; Values from 4 to 9 indicate moderate dysfunction; Values above 9 indicate severe dysfunction.
Change from Baseline Helkimo Index at 10 weeks.
Sleep
Time Frame: Change from Baseline Pittsburgh Sleep Quality Index (PUKI) at 10 weeks.
"Pittsburgh Sleep Quality Index (PUKI)" will be used to assess sleep quality and impairment. It consists of 7 subscales that assess subjective sleep quality, sleep latency and duration, habitual sleep efficiency, sleep disorders, use of sleep medication, and loss of daytime functionality. A high total score indicates poor sleep quality.
Change from Baseline Pittsburgh Sleep Quality Index (PUKI) at 10 weeks.

Collaborators and Investigators

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

Sponsor

Marmara University

Investigators

  • Study Director: Tugba Kuru Colak, Asst. Prof, Marmara University Institute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

October 22, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2022.951

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.

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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