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Adding Core Stabilization Training to Manuel Therapy in Temporomandibular Joint Disorders

Adding Core Stabilization Training to Orofacial Manuel Therapy in Individuals With Temporomandibular Joint Disc Displacement With Reduction: A Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05607823
Enrollment
45
Registered
2022-11-07
Start date
2022-11-06
Completion date
2024-02-10
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders

Keywords

core stability, exercise, Temporomandibular joint disorders, facial pain, comprehensive health care

Brief summary

This study aims to compare the effectiveness of three different treatment approaches in individuals with DDwR symptoms. It is hypothesized that adding core stabilization training (CST) to orofacial manual therapy (OMT) will enhance treatment outcomes. 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

This study aims to compare the effectiveness of three different treatment approaches in individuals with DDwR symptoms. It is hypothesized that adding core stabilization training (CST) to orofacial manual therapy (OMT) will enhance treatment outcomes. 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 Numeric Pain Scale (NPS), 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.

Interventions

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.

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.

OTHERConventional 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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants did not know which treatment group they were in.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Volunteered to participate, * Aged between 18-60 years old, * Having the diagnosis of Temporomandibular Disorders (TMD) - Reduction Disc Displacement (DDwR)

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 arthritis, * Having lumbal pathology, * Having metabolic diseases, * Having connective tissue, rheumatological and hematological disorders, * Having a diagnosed psychiatric illness, * Receiving TMD-related physical therapy less than 6 months ago

Design outcomes

Primary

MeasureTime frameDescription
Degree of lordosisChange 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.
Pain severity: VASChange from Baseline pain severity at 10 weeks.The severity of pain in the orofacial region was evaluated using a Numeric Pain Scale (NPS). The patients were instructed to mark the level of pain felt during rest, clenching and maximum mouth opening on a 10-cm line ranging from 0 (no pain) to 10 (intolerable pain).
Pain Threshold: Digital algometerChange 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.
Range of MotionChange 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.
Facial asymmetryChange 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.
Degree of pelvic tiltChange 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.

Secondary

MeasureTime frameDescription
Flexibility of hamstring musclesChange 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.
Performance of stabilizer musclesChange 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.
FunctionalityChange 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.
SleepChange 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.
Flexibility of lumbal extensor musclesChange 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026