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Adding Core Stabilization Training to Manuel Therapy in Temporomandibular Disorders

Primary Purpose

Temporomandibular Disorders, Temporomandibular Joint Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Core Stabilization Training
Orofacial Manual Therapy
Conventional Physiotherapy
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders focused on measuring core stability, exercise, pain, manuel therapies, temporomandibular disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sultan İğrekRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CST Group

OMT Group

Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Pain severity: VAS
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.
Pain Threshold: Digital algometer
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.
Range of Motion
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.
Facial asymmetry
For facial asymmetry evaluation, the distance between the anterior notch of the chin and the mandible line will be measured with a tape measure.
Degree of pelvic tilt
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.
Degree of lordosis
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.

Secondary Outcome Measures

Flexibility of lumbal extensor muscles
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.
Flexibility of hamstring muscles
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.
Performance of stabilizer muscles
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.
Functionality
"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.
Sleep
"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.

Full Information

First Posted
October 22, 2022
Last Updated
January 30, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05607823
Brief Title
Adding Core Stabilization Training to Manuel Therapy in Temporomandibular Disorders
Official Title
Adding Core Stabilization Training to Orofacial Manuel Therapy in Individuals With Temporomandibular Disorders: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders, Temporomandibular Joint Disorders
Keywords
core stability, exercise, pain, manuel therapies, temporomandibular disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
There are three study groups: 1.CST group: Participants in this group will be received core stabilization training, orofacial manuel therapy and conventional physiotherapy (Home exercise program and patient education). 2. OMT group: Participants in this group will be received orofacial manuel therapy and conventional physiotherapy (Home exercise program and patient education) as treatment. 3. Control Group: Participants in this group received only conventional physiotherapy (Home exercise program and patient education) as treatment.
Masking
Participant
Masking Description
Participants did not know which treatment group they were in.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CST Group
Arm Type
Experimental
Arm Description
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.
Arm Title
OMT Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Core Stabilization Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Orofacial Manual Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain severity: VAS
Description
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.
Time Frame
Change from Baseline pain severity at 10 weeks.
Title
Pain Threshold: Digital algometer
Description
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.
Time Frame
Change from Baseline pain threshold at 10 weeks.
Title
Range of Motion
Description
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.
Time Frame
Change from Baseline range of motion at 10 weeks.
Title
Facial asymmetry
Description
For facial asymmetry evaluation, the distance between the anterior notch of the chin and the mandible line will be measured with a tape measure.
Time Frame
Change from Baseline facial asymmetry at 10 weeks.
Title
Degree of pelvic tilt
Description
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.
Time Frame
Change from Baseline degree of pelvic tilt at 10 weeks.
Title
Degree of lordosis
Description
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.
Time Frame
Change from Baseline degree of lordosis at 10 weeks.
Secondary Outcome Measure Information:
Title
Flexibility of lumbal extensor muscles
Description
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.
Time Frame
Change from Baseline Finger-to-floor distance (EPZM) at 10 weeks.
Title
Flexibility of hamstring muscles
Description
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.
Time Frame
Change from Baseline sit-reach test at 10 weeks.
Title
Performance of stabilizer muscles
Description
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.
Time Frame
Change from Baseline lumbopelvic stabilization at 10 weeks.
Title
Functionality
Description
"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.
Time Frame
Change from Baseline Helkimo Index at 10 weeks.
Title
Sleep
Description
"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.
Time Frame
Change from Baseline Pittsburgh Sleep Quality Index (PUKI) at 10 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sultan Igrek, MSc
Phone
+05372100654
Email
sultanigrek@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tugba Kuru Colak, Asst. Prof
Organizational Affiliation
Marmara University Institute of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Sultan İğrek
City
İstanbul
ZIP/Postal Code
34275
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
Phone
05372100654

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
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Links:
URL
https://clinicaltrials.gov/ct2/show/NCT03490643
Description
Investigation of the Relationship Between Temporomandibular Disorder and Postural Analysis.
URL
https://www.jotsrr.org/abstract/assessment-of-temporomandibular-joint-dysfunctions-and-the-position-of-pelvis-2269.html
Description
Assessment of Temporomandibular Joint Dysfunctions and the Position of Pelvis
URL
https://www.semanticscholar.org/paper/Manual-therapy-for-temporomandibular-disorders%3A-A-Kalamir-Pollard/eff17b74aec032c4f05e66879a61cd158ddda70d
Description
Manual Therapy for Temporomandibular Disorders: A Review of the Literature. J Body Mov Ther.
URL
https://www.semanticscholar.org/paper/Effects-of-Core-Stability-Exercises%2C-Lumbar-and-A-%C5%A0kundri%C4%87-Vuki%C4%87evi%C4%87/47619c8a9f55f65a910228f96be0b0debffebcc6
Description
Effects of Core Stability Exercises, Lumbar Lordosis and Low- Back Pain: A Systematic Review.
URL
https://www.scielo.br/j/rdor/a/dV5P7vngMkggzjZqKrCvHsR/?lang=en
Description
Pressure pain threshold and pain perception in temporomandibular disorder patients: is there any correlation?
URL
https://go.gale.com/ps/i.do?id=GALE%7CA210224245&sid=googleScholar&v=2.1&it=r&linkaccess=abs&issn=00017019&p=AONE&sw=w&userGroupName=anon%7E1a84b215
Description
The prevalence of symptoms and signs of temporomandibular dysfunctions in patients with the posttraumatic stress disorder
URL
https://www.turkpsikiyatri.com/turkceOzet?Id=327
Description
The Validity and Reliability of the Pittsburgh Sleep Quality Index

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Adding Core Stabilization Training to Manuel Therapy in Temporomandibular Disorders

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