Efficacy of Manuel Therapy and BETY in Patients With Temporomandibular Dysfunction Related Headache

Primary outcomes

1. Change from baseline in Pain at 8 weeks and 5 months

   Time frame: Baseline, 8 weeks, 5 months

   A visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 8 weeks of intervention and at the end of 5 months from baseline.

2. Change from baseline in McGill Pain Questionnaire (SF-MPQ) at 8 weeks and 5 months

   Time frame: Baseline, 8 weeks, 5 months

   A short form of the McGill Pain Questionnaire (SF-MPQ) will be used. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.

3. Change from baseline in pain threshold at 8 weeks and 5 months

   Time frame: Baseline, 8 weeks, 5 months

   A digital pressure pain threshold algometer measuring device will be used to narrow trigger point sensitivity (Wagner Instruments, Greenwich, USA). Pain measurements of pressure to the masseter, temporal, SCM, upper trapezius, suboccipital, and levator scapula muscles will be recorded.

4. Change from baseline in the Headache Impact Test (HIT-6) at 8 weeks and 5 months

   Time frame: Baseline, 8 weeks, 5 months

   The 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 headache 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.

5. Change from baseline head posture analysis at 8 weeks and 5 months

   Time frame: Baseline, 8 weeks, 5 months

   Head posture will be measured in degrees with the goniometer as the angle between the horizontal plane and the seventh cervical vertebra and the ear line.

6. Change from baseline in the evaluation of Temporomandibular Joint (TMJ) and Cervical Region Range of Motion (ROM) at 8 weeks and 5 months

   Time frame: Baseline, 8 weeks, 5 months

   TMJ ROM: A linear ruler will be used for maximal mouth opening, right and left lateralization, and protrusion values by looking at active and passive.

   Cervical ROM: In order to measure its patency, the cervical region flexion, extension, right-left lateral flexion, and right-left rotation degrees will be measured and recorded with a goniometer.

7. Change from baseline in the viscoelastic properties at 8 weeks and 5 months

   Time frame: Baseline, 8 weeks, 5 months

   A digital MyotonPro (Myoton AS, Estonia) instrument measuring device will be used to evaluate the viscoelastic properties of the facial and neck muscles.

8. Change from baseline in jaw function limitation at 8 weeks and 5 months

   Time frame: Baseline, 8 weeks, 5 months

   Jaw function limitation will be measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients will be asked from 1 to 10 points per item (higher scores indicate worse jaw function). The JFLS-20 has 3 subscales: Mastication (6 items), Vertical Jaw Mobility (4 items), and Emotional and Verbal Expression (10 items).

9. Change from baseline in the neck disability index at 8 weeks and 5 months

   Time frame: Baseline, 8 weeks, 5 months

   The neck disability index (NDI) has become a standard tool for measuring self-assessed disability due to neck pain. Each of the 10 items receives a score from 0 to 5. The maximum score is 50.Scoring intervals for interpretation; 0 to 4 = no disability, 5 to 14 = mild, 15 to 24 = moderate, 25 to 34 = severe, Above 34 = complete

10. Change from baseline in the Pittsburgh sleep quality index at 8 weeks and 5 months

    Time frame: Baseline, 8 weeks, 5 months

    The Pittsburgh Sleep Quality Index (PUKI) will be used to assess sleep quality. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

11. Change from baseline in Fatigue severity at 8 weeks and 5 months

    Time frame: Baseline, 8 weeks, 5 months

    The fatigue severity scale has nine items. For each question, the patient is asked to choose a number from 1 to 7 that indicates how much the patient agrees with each statement, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 4 or higher generally indicates severe fatigue.

12. Change from baseline in anxiety and depression at 8 weeks and 5 months

    Time frame: Baseline, 8 weeks, 5 months

    Hospital Anxiety and Depression scale consists of 14 questions in total. The minimum score for the anxiety and depression subscales is 0, and the maximum score is 21. An increase in the score on the scale means that the severity of anxiety and depression increases. The cut-off points were determined as 10 for the anxiety subscale and 7 for the depression subscale.

13. Change from baseline in Quality of Life-Oral health impact profile-14 at 8 weeks and 5 months

    Time frame: Baseline, 8 weeks, 5 months

    The quality of life will be evaluated with Quality of Life-Oral health impact profile-14 (OHIP-14) questionnaire. The index provides a comprehensive measure of self-reported dysfunction, discomfort, and disability resulting from oral conditions whose dimensions are based on Locker's conceptual model of oral health. Responses are rated on a 5-point Likert scale: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = quite often; 4 = very often/every day. OHIP-14 scores can range from 0 to 56 and are calculated by adding the rank values for 14 items. Area scores can range from 0 to 8. Higher OHIP-14 scores indicate worse, lower scores indicate better OHRQol.

14. Change from baseline in Cognitive Exercise Therapy Approach Questionnaire at 8 weeks and 5 months

    Time frame: Baseline, 8 weeks, 5 months

    It is a measurement tool developed in accordance with the biopsychosocial model and evaluating the biopsychosocial status of patients with rheumatic disease. This scale consists of 30 items and consists of questions assessing cognitions related to functionality, mood, fatigue, sleep, pain, sociability and sexuality. The BETY Scale is a total likert-type scale consisting of 30 items. Each item is scored between 0 and 4, and a high score is associated with poor biopsychosocial status. Responses are rated on a 5-point Likert scale; 4: Always, 3: Often, 2: Sometimes, 1: Rarely, 0: No, never