Clinical trial NCT05607823: 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
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders
Temporomandibular Joint Disorders
Keywords: core stability
exercise
pain
manuel therapies
temporomandibular disorder
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain severity: VAS
timeFrame: Change from Baseline pain severity at 10 weeks.
measure: Pain Threshold: Digital algometer
timeFrame: Change from Baseline pain threshold at 10 weeks.
measure: Range of Motion
timeFrame: Change from Baseline range of motion at 10 weeks.
measure: Facial asymmetry
timeFrame: Change from Baseline facial asymmetry at 10 weeks.
measure: Degree of pelvic tilt
timeFrame: Change from Baseline degree of pelvic tilt at 10 weeks.
measure: Degree of lordosis
timeFrame: Change from Baseline degree of lordosis at 10 weeks.
Secondary outcomes:
measure: Flexibility of lumbal extensor muscles
timeFrame: Change from Baseline Finger-to-floor distance (EPZM) at 10 weeks.
measure: Flexibility of hamstring muscles
timeFrame: Change from Baseline sit-reach test at 10 weeks.
measure: Performance of stabilizer muscles
timeFrame: Change from Baseline lumbopelvic stabilization at 10 weeks.
measure: Functionality
timeFrame: Change from Baseline Helkimo Index at 10 weeks.
measure: Sleep
timeFrame: Change from Baseline Pittsburgh Sleep Quality Index (PUKI) at 10 weeks.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Sultan İğrek
Study officials:
affiliation: Marmara University Institute of Health Sciences
name: Tugba Kuru Colak, Asst. Prof
role: STUDY_DIRECTOR
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