Clinical trial NCT05927545: Efficacy of Manuel Therapy and BETY in Patients With Temporomandibular Dysfunction Related Headache
Official title: The Efficacy of Manual Therapy and BETY on Headache and Quality of Life in Patients With Temporomandibular Dysfunction Related Headache
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Disorders
Headache
Keywords: Temporomandibular Disorders, Headache, Quality of Life, Pain
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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/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

Primary outcomes:
measure: Change from baseline in Pain at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in McGill Pain Questionnaire (SF-MPQ) at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in pain threshold at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in the Headache Impact Test (HIT-6) at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline head posture analysis at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in the evaluation of Temporomandibular Joint (TMJ) and Cervical Region Range of Motion (ROM) at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in the viscoelastic properties at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in jaw function limitation at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in the neck disability index at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in the Pittsburgh sleep quality index at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in Fatigue severity at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in anxiety and depression at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in Quality of Life-Oral health impact profile-14 at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
measure: Change from baseline in Cognitive Exercise Therapy Approach Questionnaire at 8 weeks and 5 months
timeFrame: Baseline, 8 weeks, 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Abdulkadir Konukoğlu Sağlıklı Hayat Merkezi
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur TUNCER, PhD
role: STUDY_DIRECTOR
References: