The BETY-Biopsychosocial Questionnaire (BETY-BQ) in Individuals With Temporomandibular Dysfunction-Related Headache

Sponsor

Hasan Kalyoncu University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05902026

Collaborator

(none)

150

Enrollment

Location

8.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the validity and reliability of BETY-BQ as a biopsychosocial assessment tool in individuals with temporomandibular dysfunction-related headaches.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorders Headache

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 TMD-related pain, has a multifactorial structure and that chronic pain is affected by biological, psychological, and social factors (1). Biological factors (eg genetic predisposition) and psychosocial factors (eg stress) are known to contribute to the predisposition and triggering of TMJ dysfunction-related headache symptoms (2). As with many chronic pain conditions, recent research reinforces the biopsychosocial nature of common painful TMD (myalgia and/or arthralgia) and their interconnections with general health (3). Psychological, social, and functional problems of individuals with TMJ dysfunction-related headaches should be considered together and treatment targets should be determined accordingly(4). 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) which is an innovative exercise approach that targets holistic treatment techniques in accordance with the biopsychosocial model(5). 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 with each other. It was first used in patients with ankylosing spondylitis and was observed that besides its positive effects on disease activity, and also provided positive changes in anti-inflammatory parameters(6). CETA has taken its place in the literature as a biopsychosocial exercise model that can be applied safely in individuals with Multiple Sclerosis(7). 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(8). Validity and reliability studies of the developed scale were conducted in individuals diagnosed with Fibromyalgia, Rheumatoid Arthritis, Osteoarthritis, and individuals with chronic neck and chronic low back pain(5-9).

The temporomandibular joint (TMJ) is a complex structure consisting of structures such as masticatory muscles, muscles around the head and neck, ligaments, and teeth (10). Symptoms seen in TMD; 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/or 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 (11). The prevalence of TMD in the headache population is 56.1%. It indicates a relationship between TMD and the presence, frequency, and intensity of headaches. On the other hand, one of the three most common symptoms in TMD patients is headache (70%), and this headache 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 (12). Cognitive changes such as learning and 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(13). The biopsychosocial status of individuals with headaches related to TMJ dysfunction should be taken into account when evaluating the efficacy of treatment. The pathophysiology of diffuse painful TMD has been shown to be biopsychosocial and multifactorial. Research in this area draws attention to predisposing, initiating, and maintaining factors, including both environmental and bodily mechanisms(1). However, when the literature in this field is examined, it is clear that there is a need for biopsychosocial assessment tools.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Validity and Reliability of the BETY-Biopsychosocial Questionnaire (BETY-BQ) in Individuals With Temporomandibular Dysfunction-Related Headache.

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Oct 25, 2023

Anticipated Study Completion Date :

Jan 25, 2024

Outcome Measures

Primary Outcome Measures

BETY-Biopsychosocial Questionnaire (BETY-BQ) [1 week]
The BETY-Biopsychosocial Questionnaire (BETY-BQ) is used to evaluate the biopsychosocial process associated with the disease. A 5-point Likert system is used to score this scale. Each question is scored as "0= never, 1=yes rarely, 2=yes sometimes, 3=yes often, 4=yes always" and gives a total score of over 30 items. A high score means a low biopsychosocial level.

Secondary Outcome Measures

Quality of Life Scale Short Form-36 (SF-36) [1 week]
Quality of Life Scale Short Form-36 (SF-36) is one of the frequently used scales to measure quality of life. It evaluates eight different categories, such as general health perception, physical function, social function, pain, mental health, role difficulty due to physical reasons, role difficulty due to emotional reasons, and vitality, with a total of 36 sub-items. Items are scored as '0 = worst health condition, 100 = best health state'. Each subcategory is scored between 0 and 100 points, with a high score indicating good health.

Other Outcome Measures

Hospital Anxiety and Depression Scale (HADS) [1 week]
The Hospital Anxiety and Depression Scale (HADS) is a scale consisting of 14 questions 7 of these questions assess anxiety, and 7 assess depression. Likert-type measurement is used to evaluate this scale. The cut-off score for the anxiety subscale is 10/11, and for the depression, subscale is 7/8. Accordingly, those who score above these scores are considered at risk.
The Jaw Functional Limitation Scale-20 (JFLS-20) [1 week]
Jaw function limitation will be measured by the Jaw Functional Limitation Scale-20 (JFLS-20), where the patients will be asked for 1 to 10 points per item (higher scores indicate worse jaw function). The JFLS-20 has three subscales: Mastication (6 items), Vertical Jaw Mobility (4 items), and Emotional and Verbal Expression (10 items).
The Headache Impact Test (HIT-6) [1 week]
The Headache Impact Test (HIT-6) consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the following five responses: "never," "rarely," "sometimes," "very often," or "always." These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headaches on the daily life of the respondent. Scores can be interpreted using four groupings that indicate the severity of headache impact on the patient's life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ayşenur TUNCER	Gaziantep	Hasan Kalyoncu University	Turkey	27010

Sponsors and Collaborators

Hasan Kalyoncu University

Investigators

Study Director: Aysenur TUNCER, PhD, Hasan Kalyoncu University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Aysenur Tuncer, PT, PhD, Hasan Kalyoncu University

ClinicalTrials.gov Identifier:

NCT05902026

Other Study ID Numbers:

2023-61

First Posted:

Jun 13, 2023

Last Update Posted:

Jun 13, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aysenur Tuncer, PT, PhD, Hasan Kalyoncu University

Temporomandibular disorders, headache, exercise therapy

Additional relevant MeSH terms:

Temporomandibular Joint Disorders

Temporomandibular Joint Dysfunction Syndrome

Headache

Study Results

No Results Posted as of Jun 13, 2023