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

March 12, 2024 updated by: Aysenur Tuncer, Hasan Kalyoncu University

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Hasan Kalyoncu University
      • Gaziantep, Hasan Kalyoncu University, Turkey, 27010
        • Recruiting
        • Ayşenur TUNCER
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kezban BAYRAMLAR, Prof. Dr.
        • Sub-Investigator:
          • Edibe ÜNAL, Prof. Dr.
        • Sub-Investigator:
          • Yavuz YAKUT, Prof. Dr.
        • Principal Investigator:
          • Ayşenur TUNCER, PhD
        • Principal Investigator:
          • Feride ATAY, PT, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with Temporomandibular Dysfunction-Related Headache

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BETY-Biopsychosocial Questionnaire (BETY-BQ)
Time Frame: 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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Scale Short Form-36 (SF-36)
Time Frame: 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.
1 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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.
1 week
The Jaw Functional Limitation Scale-20 (JFLS-20)
Time Frame: 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).
1 week
The Headache Impact Test (HIT-6)
Time Frame: 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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Kalyoncu University

Investigators

  • Study Director: Aysenur Tuncer, PhD, Hasan Kalyoncu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

October 25, 2024

Study Completion (Estimated)

January 25, 2025

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

June 4, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-61

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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