Effcet of Temporomandibular Joint Disorder Relaxation and Myofacial Relaxation Techniques on Tension Headache

NCT05058573 | Unknown

• 1 other identifier: 10354421-2021/07-08
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this course is to investigate the effect of temporomandibular joint relaxation and myofacial relaxation techniques on quality of life , Joint range of motion, headache, depression in individuals with tension type headache.

Conditions

Tension-Type Headache

Keywords

Tension - Type Headache; Temporomandibular Joint Disorder; Myofascial Release Techniques; Temporomandibular joint release techniques; Physiotherapy

Outcome Measures

Primary Outcomes (7)

• Cervikal region range of motion measurement

  Cases will be shown and asked to perform head flexion, extension, lateral flexion and rotation movements. And active joint range of motion will be evaluated with goniometer.

  "baseline,preintervention " and "immediately after the intervention"

• Temporomandibular joint range of motion measurement

  In our study, the maximum mouth opening amount of individuals in the group will be measured with a millimeter ruler 'right , left and side movements of the jaw (laterotrusion), forward movement (protrusion) and back movement (retrusion)'.

  "baseline,preintervention " and "immediately after the intervention"

• Fonseca Questionnare

  In order to classify Temporomandibular joint dysfunction, the Fonseca questionnaire will be applied. this questionnaire consists of 10 questions. Participants are asked to answer each question in the form of Yes (10 points), Sometimes (5 points ), No (0 points). Scores of all questions are collected and the severity of temporomandibular joint dysfunction is determined. TMED-No (0-15 points), Mild-TMED (20-40 points), Moderate-TMED (45-60 points) and Severe - TMED (70-100 points).

  "baseline,preintervention " and "immediately after the intervention"

• Headache Impact Test

  This questionnaire describes the frequency of a person's headache, the degree of restriction in daily life activities and social settings due to headaches , their psychological state , changes in their cognitive function.

  "baseline,preintervention " and "immediately after the intervention"

• Beck depression scale

  In order to evaluate depression level, The beck depression scale will be used.in the scale consisting of 21 questions, each question consists of 4 styles. The questions are scored between 0-3 points dec Low scores represent good results. According to the scores obtained, (0-9) points indicate minimal depression, (10-16) points indicate mild depression, (17-29) points indicate moderate depression, and (30-63) points indicate severe depression

  "baseline,preintervention " and "immediately after the intervention"

• Beck Anxiety Sacle

  In order to evaluate anxiety level, The beck depression scale will be used.in this scale consisting of 21 items, a quadruple Likert type measurement is performed. 0 points = none ,1 point = light , 2 points =medium , 3 points = serious. the december of 8-15 points is expressed as mild anxiety symptoms, moderate anxiety dec 16-25 points, severe anxiety symptoms from 26-63 points.

  "baseline,preintervention " and "immediately after the intervention"

• General short form quality of life scale

  In order to evaluate the quality of life, the short form quality of life will be used.SF-36 is a test consisting of 36 items used to obtain information about a person's physical, emotional, and general health status. This test includes 8 subscales ; mental state ,energy, pain, physical function, limitation due to physical problems, restriction due to emotional problems, social function and general health. it is evaluated with a score of 0-100 points.dec. High marks indicate a good state of health.

  "baseline,preintervention " and "immediately after the intervention"

Study Arms (3)

Myofascial relaxation technique + Temporomandibular joint release techniques group (n=22)

EXPERIMENTAL

medical treatment + temporomandibular joint relaxation (temporalis, masseter, and suboccipital muscles) + myofasial release/trigger points (trapezius, rhomboideus, and levator scapulae, sternocleidomastoideus muscles),

Other: Control group (n=22)

Temporomandibular joint release techniques group (n=22)

EXPERIMENTAL

only temporomandibular joint relaxation will be performed in this group (temporalis, masseter, and suboccipital muscles).

Other: Control group (n=22)

Control group (n=22)

EXPERIMENTAL

only medication treatment will be applied

Other: Control group (n=22)

Interventions

Control group (n=22) OTHER

Control group will be received only medical treatment

Control group (n=22); Myofascial relaxation technique + Temporomandibular joint release techniques group (n=22); Temporomandibular joint release techniques group (n=22)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals diagnosed with tension-type headache by a specialist physician
• individuals diagnosed with Temporomandibular joint dysfunction by dentist-maxillofacial surgeon
• To be able to read and understand Turkish
• Have not received any medical treatment in the last 1 year.

You may not qualify if:

• who received physical therapy for TMED in the previous 6 months
• who with any neurological problems
• who with any mental prolems
• who with any konjenital disorders
• who have undergone any cervikal or cranial surgery
• who have any facial trauma or facial paralyses
• who have advanced cervikal disc herniation
• who have ankylosing spondlitis, rhematoid arthritis, fibromyalgia
• who have any cominication problems

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead

Study Sites (1)

Alanyaaku

Antalya, Alanya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tension-Type Headache; Temporomandibular Joint Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hanifegül Taşkıran, Prof. Dr

  İstanbul Aydın University

  STUDY CHAIR

• Mustafa Zafer DEMİRTAŞ, MD

  Alanya Alaaddin Keykubat University

  STUDY DIRECTOR

• Ertan KARAÇAY, MD

  Alanya Alaaddin Keykubat University

  STUDY DIRECTOR

• Ahmet ÖZŞİMŞEK, PHD MD

  Alanya Alaaddin Keykubat University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: it was calculated that 80% power could be achieved at a 95% confidence level when at least 66 people (at least 22 people for each group) were taken into the study. Therefore, our study Decocking TMJ+myofascial release+ a classic medical treatment (N= 25), TMJ Decocking+ classical medical treatment (N= 25), just the usual medical therapy (N=25) Group 3 group to be 75 individuals will be included. Assessments will be made before and after treatment. Treatment will be carried out in the form of 8 sessions in an average of 20-30 minute sessions 2 days a week for 4 weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist,principal investigator, pHd

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 27, 2021
• Study Start: April 10, 2021
• Primary Completion: June 10, 2021
• Study Completion: November 15, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

TU (1)