Efficacy of Manuel Therapy and BETY in Patients With Temporomandibular Dysfunction Related Headache

Hasan Kalyoncu University

Status: Enrolling

Conditions: Temporomandibular Disorders; Headache

Treatments: Procedure: Patient education and preventive exercise; Procedure: Patient education, preventive exercise combined with BETY approach; Procedure: Patient education, preventive exercise combined with Manual Therapy protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05927545

2023-101

Details and patient eligibility

About

The aim of the study is to investigate the effects of Manual Therapy and the Cognitive Exercise Therapy Approach treatment in patients with TMD-related headaches.

Full description

60 subjects with TMD-related headaches, according to ICHD-3, will be included in the study after the voluntary consent form will be filled out. Subjects will randomly be divided into 3 groups according to the order.

Group 1: Patient education and exercise group: The patients in this group will be taught an exercise program after general education. Education training program about parafunctional activities of TMD and active exercises for masticatory and neck muscles. Patients will be asked to complete and follow-up home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks. The continuity of the exercises will be ensured by sending reminder messages to this group of patients about doing their exercises once a week by the physiotherapist.

Group 2; Manuel Therapy group: This group will receive the same patient education and exercises additionally manual therapy program which is planned to last 45 minutes will be applied twice a week, for 8 weeks.

Group 3; BETY group: This group will receive the same patient education and exercises in addition BETY approach, which is the Cognitive Exercise Therapy Approach treatment, will be applied in 2 sessions a week for 45 minutes and a total of 8 weeks of treatment.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages between 18 and 60 years old
• Getting a diagnosis of TMD-related headache
• Not having received FTR and manual therapy in the last 3 months
• Having pain ≥ 50 or more according to the headache impact test (HIT 6)
• Patients who have not received medical treatment in the last 3 months and will not receive medical treatment during the treatment
• Patients who describe pain in the jaw, face, temporal region or ear for at least 6 months and who have pain in the chewing muscles with palpation

Exclusion criteria

• Ages under 18 and over 60 years old
• Patients with disc displacement and/or attachment degeneration
• Patients with dental infection
• Patients who have undergone facial and ear surgery in the last six months
• Patients undergoing orthodontic treatment
• Patients using regular analgesics or anti-inflammatory drugs
• Patients with a history of trauma (whiplash injury, condylar trauma, fracture),
• Patients who have undergone any surgery related to the cervical and/or TMJ
• Patients with facial paralysis
• Patients with missing teeth in the upper jaw
• Patients with cognitive deficits
• Participation rate lower than 80% of the program schedule

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Home Exercise: Patient Education and Preventive Exercise

Active Comparator group

Description:

Group 1: The home Exercise Program includes an educational training program about parafunctional activities and correction exercises for patients having TMD-related headaches. The program includes tongue resting position, diaphragmatic breathing, head posture correction exercises, stretching and strengthening exercises for shoulder and back muscles, and active cervical and thoracic mobilization.

Treatment:

Procedure: Patient education and preventive exercise

Manual Therapy Combined with Home Exercise

Active Comparator group

Description:

Group 2: MT group includes in addition to the home exercise program, deep friction massage, myofascial release techniques and stretching techniques to masticatory and neck muscles, temporomandibular joint and cervical mobilization will be applied.

Treatment:

Procedure: Patient education, preventive exercise combined with Manual Therapy protocol

Cognitive Exercise Therapy Approach Combined with Home Exercise

Active Comparator group

Description:

Group 3: Cognitive Exercise Therapy Approach (CETA) includes cognitive exercise therapy and the home exercise program. The Cognitive Exercise Therapy approach is an innovative exercise approach that aims to change the patient's cognition about the disease through exercise and is suitable for the biopsychosocial model. CETA is an exercise approach aimed at changing the patient's cognitive perception of the disease through exercise, placing the responsibility of disease management on the patient. The approach will be explained in the first session, and patients will be taught proper posture for the neck, shoulders, thoracic, and lumbopelvic region, as well as correct breathing control. Each 1-hour session will include a warm-up, exercise period, and cool-down.

Treatment:

Procedure: Patient education, preventive exercise combined with BETY approach