Adding Core Stabilization Training to Manuel Therapy in Temporomandibular Joint Disorders

NCT05607823 | Completed

• 1 other identifier: 09.2022.951
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Pain severity: VAS

  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).

  Change from Baseline pain severity at 10 weeks.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (5)

• Flexibility of lumbal extensor muscles

  Change from Baseline Finger-to-floor distance (EPZM) at 10 weeks.

• Flexibility of hamstring muscles

  Change from Baseline sit-reach test at 10 weeks.

• Performance of stabilizer muscles

  Change from Baseline lumbopelvic stabilization at 10 weeks.

• Functionality

  Change from Baseline Helkimo Index at 10 weeks.

• Sleep

  Change from Baseline Pittsburgh Sleep Quality Index (PUKI) at 10 weeks.

Study Arms (3)

CST Group

EXPERIMENTAL

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; Other: Orofacial Manual Therapy; Other: Conventional Physiotherapy

OMT Group

EXPERIMENTAL

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; Other: Conventional Physiotherapy

Control Group

EXPERIMENTAL

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

Interventions

Core Stabilization Training OTHER

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.

CST Group

Orofacial Manual Therapy OTHER

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.

CST Group; OMT Group

Conventional Physiotherapy OTHER

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.

CST Group; Control Group; OMT Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Sultan İğrek

Istanbul, 34275, Turkey (Türkiye)

Location

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Related Links

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

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Motor Activity; Facial Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tugba Kuru Colak, Asst. Prof

  Marmara University Institute of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants did not know which treatment group they were in.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: November 7, 2022
• Study Start: November 6, 2022
• Primary Completion: November 1, 2023
• Study Completion: February 10, 2024
• Last Updated: August 27, 2025

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)