Adding Core Stabilization Training to Manuel Therapy in Temporomandibular Disorders

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607823
• Other study ID #: 09.2022.951
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2022
• Source: Marmara University
• Contact: Sultan Igrek, MSc
• Phone: +05372100654
• Email: sultanigrek[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Joint Diseases
• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Sultan Igrek	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline pain severity at 10 weeks.
Primary	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.	Change from Baseline pain threshold at 10 weeks.
Primary	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.	Change from Baseline range of motion at 10 weeks.
Primary	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.	Change from Baseline facial asymmetry at 10 weeks.
Primary	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.	Change from Baseline degree of pelvic tilt at 10 weeks.
Primary	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.	Change from Baseline degree of lordosis at 10 weeks.
Secondary	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.	Change from Baseline Finger-to-floor distance (EPZM) at 10 weeks.
Secondary	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.	Change from Baseline sit-reach test at 10 weeks.
Secondary	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.	Change from Baseline lumbopelvic stabilization at 10 weeks.
Secondary	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.	Change from Baseline Helkimo Index at 10 weeks.
Secondary	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.	Change from Baseline Pittsburgh Sleep Quality Index (PUKI) at 10 weeks.

External Links

•   Assessment of Temporomandibular Joint Dysfunctions and the Position of Pelvis
•   Effects of Core Stability Exercises, Lumbar Lordosis and Low- Back Pain: A Systematic Review.
•   Investigation of the Relationship Between Temporomandibular Disorder and Postural Analysis.
•   Manual Therapy for Temporomandibular Disorders: A Review of the Literature. J Body Mov Ther.
•   Pressure pain threshold and pain perception in temporomandibular disorder patients: is there any correlation?
•   The prevalence of symptoms and signs of temporomandibular dysfunctions in patients with the posttraumatic stress disorder
•   The Validity and Reliability of the Pittsburgh Sleep Quality Index