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

The Efficacy of Manual Therapy and BETY on Headache and Quality of Life in Patients With Temporomandibular Dysfunction Related Headache

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.

Study Overview

• Status: Recruiting
• Conditions: Headache; Temporomandibular Disorders
• Intervention / Treatment: Procedure: Patient education and preventive exercise; Procedure: Patient education, preventive exercise combined with Manual Therapy protocol; Procedure: Patient education, preventive exercise combined with BETY approach

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aysenur TUNCER, PT, PhD; Phone Number: +90-342 2118080; Email: aysenur.tuncer@hku.edu.tr
• Study Contact Backup: Name: Feride ATAY, PT, MSc; Phone Number: +90 5426066002; Email: feride_atay@hotmail.com

Study Locations

• Turkey
  • Gaziantep, Turkey, 27560
    • Recruiting
    • Abdulkadir Konukoğlu Sağlıklı Hayat Merkezi
    • Contact: Aysenur TUNCER, PT, PhD; Phone Number: +90-342 2118080; Email: aysenur.tuncer@hku.edu.tr
    • Contact: Feride ATAY, PT, MSc; Phone Number: +90 5426066002; Email: feride_atay@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

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/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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Home Exercise: Patient Education and Preventive Exercise; Group 1: The home Exercise Program includes an educational training program about parafunctional activities and correction exercises for patients having TMD-related headaches. The program includes tongue resting position, diaphragmatic breathing, head posture correction exercises, stretching and strengthening exercises for shoulder and back muscles, and active cervical and thoracic mobilization.	Procedure: Patient education and preventive exercise; Educational training program and prevention exercises about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches.
Active Comparator: Manual Therapy Combined with Home Exercise; Group 2: MT group includes in addition to the home exercise program, deep friction massage, myofascial release techniques and stretching techniques to masticatory and neck muscles, temporomandibular joint and cervical mobilization will be applied.	Procedure: Patient education, preventive exercise combined with Manual Therapy protocol; Manual therapy program combined with the educational training program and prevention exercise about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches.
Active Comparator: Cognitive Exercise Therapy Approach Combined with Home Exercise; Group 3: Cognitive Exercise Therapy Approach (CETA) includes cognitive exercise therapy and the home exercise program. The Cognitive Exercise Therapy approach is an innovative exercise approach that aims to change the patient's cognition about the disease through exercise and is suitable for the biopsychosocial model. CETA is an exercise approach aimed at changing the patient's cognitive perception of the disease through exercise, placing the responsibility of disease management on the patient. The approach will be explained in the first session, and patients will be taught proper posture for the neck, shoulders, thoracic, and lumbopelvic region, as well as correct breathing control. Each 1-hour session will include a warm-up, exercise period, and cool-down.	Procedure: Patient education, preventive exercise combined with BETY approach; BETY therapy program combined with the educational training program and prevention exercise about temporomandibular dysfunction in patients with temporomandibular dysfunction-associated headaches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Pain at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline in McGill Pain Questionnaire (SF-MPQ) at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline in pain threshold at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline in the Headache Impact Test (HIT-6) at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline head posture analysis at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline in the evaluation of Temporomandibular Joint (TMJ) and Cervical Region Range of Motion (ROM) at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline in the viscoelastic properties at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline in jaw function limitation at 8 weeks and 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).	Baseline, 8 weeks, 5 months
Change from baseline in the neck disability index at 8 weeks and 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	Baseline, 8 weeks, 5 months
Change from baseline in the Pittsburgh sleep quality index at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline in Fatigue severity at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline in anxiety and depression at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline in Quality of Life-Oral health impact profile-14 at 8 weeks and 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.	Baseline, 8 weeks, 5 months
Change from baseline in Cognitive Exercise Therapy Approach Questionnaire at 8 weeks and 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	Baseline, 8 weeks, 5 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 25, 2024
• Study Completion (Estimated): December 25, 2024

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Temporomandibular Disorders, Headache, Quality of Life, Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Headache; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 2023-101

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