NCT05902026

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
Last Updated

May 15, 2025

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

June 4, 2023

Last Update Submit

May 13, 2025

Conditions

Keywords

Temporomandibular disordersHeadacheExercise Therapy

Outcome Measures

Primary Outcomes (1)

  • BETY-Biopsychosocial Questionnaire (BETY-BQ)

    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 Outcomes (1)

  • Quality of Life Scale Short Form-36 (SF-36)

    1 week

Other Outcomes (3)

  • Hospital Anxiety and Depression Scale (HADS)

    1 week

  • The Jaw Functional Limitation Scale-20 (JFLS-20)

    1 week

  • The Headache Impact Test (HIT-6)

    1 week

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with Temporomandibular Dysfunction-Related Headache

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşenur TUNCER

Gaziantep, Hasan Kalyoncu University, 27010, Turkey (Türkiye)

Location

Related Publications (17)

  • Kapos FP, Exposto FG, Oyarzo JF, Durham J. Temporomandibular disorders: a review of current concepts in aetiology, diagnosis and management. Oral Surg. 2020 Nov;13(4):321-334. doi: 10.1111/ors.12473. Epub 2020 Jan 25.

    PMID: 34853604BACKGROUND
  • Chisnoiu AM, Picos AM, Popa S, Chisnoiu PD, Lascu L, Picos A, Chisnoiu R. Factors involved in the etiology of temporomandibular disorders - a literature review. Clujul Med. 2015;88(4):473-8. doi: 10.15386/cjmed-485. Epub 2015 Nov 15.

    PMID: 26732121BACKGROUND
  • Ohrbach, R., & Sharma, S. (2021). Behavioral therapy for temporomandibular disorders. Frontiers of Oral and Maxillofacial Medicine, 3, 37-37.

    BACKGROUND
  • Oflaz, F.B., Bilişsel Egzersiz Terapi Yaklaşımı Ölçeği'nin Romatoid Artrit Tanısı Alan Bireylerde Geçerliği, Güvenirliği Ve Duyarlılığının Belirlenmesi. 2018, Sağlık Bilimleri Enstitüsü.

    BACKGROUND
  • Kisacik P, Unal E, Akman U, Yapali G, Karabulut E, Akdogan A. Investigating the effects of a multidimensional exercise program on symptoms and antiinflammatory status in female patients with ankylosing spondylitis. Complement Ther Clin Pract. 2016 Feb;22:38-43. doi: 10.1016/j.ctcp.2015.11.002. Epub 2015 Dec 2.

    PMID: 26850804BACKGROUND
  • Küçüktepe, İ., et al., Multiple sklerozlu bireylerde Bilişsel Egzersiz Terapi Yaklaşımı'nın yorgunluk ve denge üzerine etkileri. 2018. 5(2): p. 74-81.

    BACKGROUND
  • Edibe, Ü., et al., Romatizmalı hastalar için bir yaşam kalitesi ölçeğinin geliştirilmesi: madde havuzunun oluşturulması. Journal of Exercise Therapy and Rehabilitation 2017. 4(2): p. 67-75.

    BACKGROUND
  • ZAHİD, M., Bilişsel Egzersiz Terapi Yaklaşımı Ölçeği'nin Fibromiyalji Tanısı Alan Bireylerde Geçerliği, Güvenirliği ve Duyarlılığının Belirlenmesi. 2018, Sağlık Bilimleri Enstitüsü

    BACKGROUND
  • Okeson JP. Orofacial pain. In: Guidelines for assessment, diagnosis and management. Chicago: Quintessence Publishing Co;113-184,1996.

    BACKGROUND
  • Günay, Y., Bellaz, İ., Gürgan, C., Gülten, T., & Haskan, H. (1998). Temporomandibular eklem disfonksiyonunda semptomların dağılımı-dıstrubıtıon of semptoms of temporomandıbular joınt dısorder. Journal of Istanbul University Faculty of Dentistry, 32(4), 177-182.

    BACKGROUND
  • Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

    PMID: 29368949BACKGROUND
  • Skov T, Borg V, Orhede E. Psychosocial and physical risk factors for musculoskeletal disorders of the neck, shoulders, and lower back in salespeople. Occup Environ Med. 1996 May;53(5):351-6. doi: 10.1136/oem.53.5.351.

    PMID: 8673184BACKGROUND
  • Ünal, E., Arin, G., Karaca, N. B., Kiraz, S., Akdoğan, A., Kalyoncu, U., ... & Kılıç, L. (2017). Romatizmalı hastalar için bir yaşam kalitesi ölçeğinin geliştirilmesi: madde havuzunun oluşturulması. Journal of Exercise Therapy and Rehabilitation, 4(2): 67-75.

    BACKGROUND
  • Koçyiğit, H., Ö. Aydemir, and G.J.R.h.o.b.g.h.i.ç.İ.v.T.D. Fişek, Kısa Form-36'nın (KF-36) Türkçe için güvenilirliği ve geçerliliği. 1999. 12: p. 102-106.

    BACKGROUND
  • Aydemir, Ö., Güvenir, T., Küey, L., Kültür, S. (1997). Hospital Anxiety and Depression Scale Turkish Form: validation and reliability study. Türk Psikiyatri Der. 8(4): 280-287.

    BACKGROUND
  • https://ubwp.buffalo.edu/rdc-tmdinternational/tmd-assessmentdiagnosis/dc-tmd/dc-tmd-translations

    BACKGROUND
  • Sertel M, Bakar Y, Simsek TT. THE EFFECT OF BODY AWARENESS THERAPY AND AEROBIC EXERCISES ON PAIN AND QUALITY OF LIFE IN THE PATIENTS WITH TENSION TYPE HEADACHE. Afr J Tradit Complement Altern Med. 2017 Jan 13;14(2):288-310. doi: 10.21010/ajtcam.v14i2.31. eCollection 2017.

    PMID: 28573246BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersHeadache

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aysenur TUNCER, PhD

    Hasan Kalyoncu University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 4, 2023

First Posted

June 13, 2023

Study Start

January 30, 2025

Primary Completion

September 30, 2025

Study Completion

December 25, 2025

Last Updated

May 15, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations