Investigation of the Effectiveness of Manual Therapy Based on Fascial Distortion Model in Individuals With Temporomandibular Disorder: A Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Head posture
研究概览
简要总结
The aim of the study was to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with temporomandibular disorders compared to sham control. Individuals diagnosed with temporomandibular disorder will be randomly assigned to groups as Group 1 (Manual Therapy Based on Fascial Distortion Model) and Group 2 (Sham Control). Head posture, cervical and temporomandibular joint range of motion, cervical muscle performance, pain intensity, pressure pain thresholds, temporomandibular disorder severity, disability, dysfunction, health-related quality of life, kinesiophobia, and central sensitization will be assessed.
详细描述
Interventions are needed to address head posture, cervical and temporomandibular joint range of motion, cervical muscle performance, pain intensity, pressure pain thresholds, temporomandibular disorder severity, disability, dysfunction, health-related quality of life, kinesiophobia, and central sensitization in individuals with temporomandibular disorder (TMD). This study aims to examine the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with TMDs compared to sham control over a 4-week period. Individuals with TMD will be randomized into Group 1 (Fascial Distortion Model-based Manual Therapy) or Group 2 (Sham Control). Interventions will be conducted once a week in a clinical setting. Head posture will be measured by lateral photogrammetry, cervical range of motion will be measured by an inclinometer, temporomandibular range of motion will be measured by a vernier caliper, cervical muscle performance will be measured by Cervical Spine Functional Strength Test, and pressure pain threshold will be measured by an algometer. Pain intensity will be assessed using the Graded Chronic Pain Scale (Revised) and the Short-Form McGill Pain Questionnaire. TMD severity will be assessed using the Fonseca Anamnestic Index. Mandibular Function Impairment Questionnaire will be used to assess dysfunction. Disability will be evaluated using the Craniofacial Pain and Disability Inventory. Health-related quality of life will be assessed using Short Form-36. Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale; central sensitization will be assessed with the Central Sensitisation Inventory.
All outcomes will be measured at baseline and end of the study, while pain intensity and pressure pain thresholds will also undergo intermediate assessments (2nd and 3rd week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having temporomandibular joint complaints and being diagnosed with temporomandibular disorder according to the Diagnostic Criteria for Temporomandibular Disorders Axis I
- •Understand and be willing to answer assessment questions
- •A temporomandibular joint complaint for the last three months
- •Pain in the jaw, face or neck
排除标准
- •Has a systemic disease (neurological, rheumatologic, oncologic, etc.) that may affect the temporomandibular joint, cervical spine and/or assessment
- •Any history of trauma that may have affected the cranio-cervico-facial region
- •Having undergone any surgical intervention in the cranio-cervico-facial region within the last six months
- •Receiving surgical treatment, medical treatment, splint therapy or physiotherapy for temporomandibular disorder in the last month
- •Radiotherapy in the head and neck region
- •Pregnancy or breastfeeding
- •Exercise therapy for craniocervical posture for the last month
研究组 & 干预措施
Manual Therapy based Fascial Distortion Model
It will conducted for forty-five minutes once a week in a clinical setting for 4 weeks.
干预措施: Fascial Distortion Model (Procedure)
Control
Sham application will conducted for forty-five minutes once a week in a clinical setting for 4 weeks.
干预措施: Sham treatment (Procedure)
结局指标
主要结局
Head posture
时间窗: From enrollment to the end of treatment at 4th week
Lateral photogrammetry according to Eye-Tragus-Horizontal Angle, Pogonion-Tragus-C7 Angle, Tragus-C7-Horizontal Angle, Tragus-C7-Shoulder Angle, and Shoulder-C7-Horizontal Angle.
Cervical range of motions
时间窗: From enrollment to the end of treatment at 4th week
Inclinometric measurements based on flexion, extension, lateral flexions, and rotations.
Temporomandibular range of motions
时间窗: From enrollment to the end of treatment at 4th week
Digital vernier caliper measurements based on maximum pain-free mouth opening, maximum possible mouth opening, maximum possible assisted mouth opening, laterotrusions, and protrusion.
Cervical muscle performance
时间窗: From enrollment to the end of treatment at 4th week
The Functional Strength Testing of the Cervical Spine was used to evaluate the cervical muscle performance. This is a test that functionally evaluates cervical muscle strength. Results of this test are assessed as functional, functionally fair, functionally poor, and nonfunctional. Six-to-eight repetitions for the flexion test and 20-25 s holding time for the other tests indicate that the test result is functional. Three-to-five repetitions for the flexion test and 10-19 s holding time for the other tests indicate that the test result is functionally fair. One-to-two repetitions for the flexion test and 1-9 s holding time for the other tests indicate that the test result is functionally poor. Zero repetition for the flexion test and 0 s holding time for the other tests indicate that the test result is nonfunctional. Each test was terminated at onset of pain, and the relevant value was recorded.
Pressure pain threshold
时间窗: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Algometer. Tempormandibular joint, masseter, temporalis anterior, suboccipital muscle, trapezius, lateral epicondyle for both side.
Pain intensity in the last week
时间窗: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Chronic pain intensity
时间窗: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Graded Chronic Pain Scale (Revised). Scoring: Grade 1=mild, Grade 2=bothersome, Grade 3=high impact chronic pain. Higher scores mean a worse outcome.
Temporomandibular disorders severity
时间窗: From enrollment to the end of treatment at 4th week
Fonseca Anamnestic Index. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
Dysfunction
时间窗: From enrollment to the end of treatment at 4th week
Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Disability
时间窗: From enrollment to the end of treatment at 4th week
Craniofacial Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Health-related quality of life
时间窗: From enrollment to the end of treatment at 4th week
Short Form-36. Its subdomains are physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
Kinesiophobia
时间窗: From enrollment to the end of treatment at 4th week
Tampa Kinesiophobia Scale for Temporomandibular Disorders. Minimum and maximum values are 1 and 4 points, respectively. Higher scores mean a worse outcome.
Central sensitization
时间窗: From enrollment to the end of treatment at 4th week
Central Sensitisation Inventory. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Present pain intensity
时间窗: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Present pain intensity (ordinal)
时间窗: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Present pain intensity scale of McGill Pain Questionnaire. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Pain intensity in the last week (ordinal)
时间窗: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.
Numeric Pain Rating Scale. Minimum and maximum values are 0 and 10 points, respectively. Higher scores mean a worse outcome.
次要结局
未报告次要终点
研究者
Harun Gençosmanoğlu
Lecturer
Karabuk University