Clinical trial NCT05902026: The BETY-Biopsychosocial Questionnaire (BETY-BQ) in Individuals With Temporomandibular Dysfunction-Related Headache
Official title: Validity and Reliability of the BETY-Biopsychosocial Questionnaire (BETY-BQ) in Individuals With Temporomandibular Dysfunction-Related Headache.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Temporomandibular Disorders
Headache
Keywords: Temporomandibular disorders
Headache
Exercise Therapy
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Temporomandibular Dysfunction-Related Headache

Brief summary: This study investigates the validity and reliability of the BETY- Biopsychosocial Questionnaire (BETY-BQ) as a biopsychosocial assessment tool in individuals with temporomandibular dysfunction-related headaches.

Detailed description: It is known that pain is a powerful motivational component and creates a complex experience that cannot be explained by illness, injury, or structural problems alone. It is emphasized that pain, including temporomandibular dysfunction-related pain, has a multifactorial structure and that chronic pain is affected by biological, psychological, and social factors. Biological and psychosocial factors contribute to the predisposition and triggering of temporomandibular dysfunction-related headache symptoms. As with many chronic pain conditions, recent research reinforces the biopsychosocial nature of joint painful temporomandibular dysfunction (myalgia and arthralgia) and their interconnections with general health. Psychological, social, and functional problems of individuals with TMJ dysfunction-related headaches should be considered together, and treatment targets should be determined accordingly. The biopsychosocial being of humans is the main reason for this approach. BETY- Biopsychosocial Questionnaire (BETY-BQ) originates from the Cognitive Exercise Therapy Approach (CETA), an innovative exercise approach that targets holistic treatment techniques per the biopsychosocial model. This approach contains concepts including function-oriented trunk stabilization exercises, pain management, mood management (dance therapy-authentic movement), and sexual knowledge management which are combined. It was first used in patients with ankylosing spondylitis, and it was observed that besides its positive effects on disease activity, and also provided positive changes in anti-inflammatory parameters. CETA has taken place in the literature as a biopsychosocial exercise model that can be applied safely in individuals with Multiple Sclerosis. Patients with rheumatism, who have participated in CETA training since 2004, described their recovery characteristics in 2013. The questionary was finalized in 2017 by applying this feedback to repetitive statistics and rheumatic patients who did not participate in the group. Validity and reliability studies of the developed scale were conducted in individuals diagnosed with Fibromyalgia, Rheumatoid Arthritis, Osteoarthritis, and chronic neck and low back pain.

The temporomandibular joint is a complex structure consisting of masticatory muscles, muscles around the head and neck, ligaments, and teeth. Symptoms seen in temporomandibular dysfunction; pain and tenderness in the muscles and temporomandibular joint; significant or minor limitation of jaw joint movements; clicking sound in the joint during mouth opening and closing, crepitation; a feeling of fullness in the ears, ear pain, tinnitus, and vertigo; emotional disorders such as the deflection of mouth opening, deviation, deterioration in chewing patterns, locking in the jaw, anxiety, depression can be listed as headache. The prevalence of temporomandibular dysfunction in the headache population is 56.1%. It indicates a relationship between temporomandibular dysfunction and headaches' presence, frequency, and intensity. On the other hand, one of the three most common symptoms in temporomandibular dysfunction patients is headache, which is characteristically tension-type. Studies have shown that headache develops in a temporal relationship with temporomandibular disorder and may experience problems such as pain, limitation of movement, and sensitivity. Cognitive changes such as learning, memory, and attention to the painful area that develops with the affected limbic system increase avoidance of movements. However, muscle spasms, pain, negative mood that leads to a vicious circle, and experiences that lead to limitation of movement can be experienced. Therefore, physical and psychosocial factors are also associated with musculoskeletal disorders. The biopsychosocial status of individuals with headaches related to temporomandibular dysfunction should be considered when evaluating treatment efficacy. The pathophysiology of diffuse painful temporomandibular dysfunction is biopsychosocial and multifactorial. Research in this area draws attention to predisposing, initiating, and maintaining factors, including environmental and bodily mechanisms. However, when the literature in this field is examined, it is clear that there is a need for biopsychosocial assessment tools.

Eligibility criteria: 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 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 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

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire (BETY-BQ)
timeFrame: 1 week
Secondary outcomes:
measure: Quality of Life Scale Short Form-36 (SF-36)
timeFrame: 1 week
Other outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 week
measure: The Jaw Functional Limitation Scale-20 (JFLS-20)
timeFrame: 1 week
measure: The Headache Impact Test (HIT-6)
timeFrame: 1 week
Locations:
city: Gaziantep
country: Turkey
facility: Ayşenur TUNCER
state: Hasan Kalyoncu University
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur TUNCER, PhD
role: STUDY_DIRECTOR
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