Effectiveness of Manual Therapy Based on the Fascial Distortion Model on the Cervical Spine in Individuals with Temporomandibular Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Pogonion-Tragus-C7 Angle on lateral photography of head posture
研究概览
简要总结
The goal of this randomized clinical trial is to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model (FDM) on the cervical spine by comparing it with Core Stabilization Training (CST) or Control in individuals with temporomandibular disorders. The main questions it aims to answer are:
Is the effectiveness of the addition of FDM-based Manual Therapy to conventional therapy different from the addition of CST or control? Is the effectiveness of the addition of CST to conventional therapy different from the addition of FDM or control? All participants in the intervention groups will be given eight-week conventional therapy (Rocabado Exercises and Patient Education) in addition to FDM-based Manual Therapy or CST. Participants in the control group will not be given any therapy during the study.
Neck pain intensity, hand grip strength, head posture, cervical muscle performance, cervical range of motion (function), disability, and quality of life will be assessed.
详细描述
Interventions are needed to address neck pain intensity, hand grip strength, head posture, cervical muscle performance, cervical range of motion (function), disability, and quality of life in individuals with temporomandibular disorder (TMD). This study aims to examine the effectiveness of Fascial Distortion Model-based Manual Therapy compared to Core Stabilization Training or Control in individuals with TMD over an 8-week period. Individuals with TMD will be randomized into Group 1 (Fascial Distortion Model-based Manual Therapy, Rocabado Exercises, and Patient Education), Group 2 (Core Stabilization Training, Rocabado Exercises, and Patient Education), or Group 3 (Control). Rocabado Exercises and Patient Education will be implemented as a home program for 8 weeks, while Fascial Distortion Model-based Manual Therapy and Core Stabilization Training will be conducted once a week in a clinical setting. Neck pain intensity will be assessed using the Graded Chronic Pain Scale (Revised) and the Short-Form McGill Pain Questionnaire. Hand grip strength and head posture will be assessed using a hand dynamometer and lateral photography, respectively. The Functional Strength Testing of the Cervical Spine and cervical range of motions will be used to assess cervical muscle performance and function, respectively. Disability and quality of life will be evaluated using the Neck Disability Index and the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. All outcomes will be measured at baseline and end of the study, while neck pain intensity will also undergo intermediate assessments (2nd, 4th, and 6th weeks).
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
- None
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 a temporomandibular joint complaint that has persisted for three months
- •Being diagnosed with temporomandibular disorder according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I
- •Comprehension and interest in responding to assessment questions
排除标准
- •Having a systemic condition (neurological, rheumatological, oncological, etc.) that could affect the temporomandibular joint and/or interfere with the evaluation
- •History of any trauma that may have affected cranial, cervical, or facial region
- •Having undergone any surgical intervention in cranial, cervical, or facial regions in the previous six months
- •Receiving any surgical treatment, medical treatment, or physiotherapy for temporomandibular disorder in the last month
- •Having received radiotherapy in the cranial or cervical region
- •Pregnancy or breastfeeding
- •Exercise for head posture for the last month
结局指标
主要结局
Pogonion-Tragus-C7 Angle on lateral photography of head posture
时间窗: From enrollment to the end of treatment at 8 weeks
The angle between the line connecting the pogonion (the most protruding point on the front of the mandible) to the tragus and the line connecting the tragus to the C7 vertebra
Tragus-C7-Horizontal Angle on lateral photography of head posture
时间窗: From enrollment to the end of treatment at 8 weeks
The angle between the line connecting the tragus to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the neck inclination angle
Disability based on Neck Disability Index
时间窗: From enrollment to the end of treatment at 8 weeks
Neck Disability Index. Minimum and maximum values are 0 and 5 points, respectively. Higher scores mean a worse outcome.
Cervical active range of motion
时间窗: From enrollment to the end of treatment at 8 weeks
Dijital inclinometric measurements. Flexion, extension, right and left lateral flexions and right and left rotations.
Neck pain intensity at last seven days based on Short-Form McGill Pain Questionnaire
时间窗: Baseline, 2nd week, 4th week, 6th week and 8th week
Short-Form McGill Pain Questionnaire. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Present neck pain intensity (ordinal)
时间窗: Baseline, 2nd week, 4th week, 6th week and 8th 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.
Eye-Tragus-Horizontal Angle on lateral photography of head posture
时间窗: From enrollment to the end of treatment at 8 weeks
The angle between the line connecting the midpoint of the lateral corner of the eye to the tragus of ear and the horizontal line emerging from the tragus level. It refers to the cranial rotation angle
Tragus-C7-Shoulder Angle on lateral photography of head posture
时间窗: From enrollment to the end of treatment at 8 weeks
The angle between the line connecting the acromion to the C7 vertebra and the line connecting the C7 vertebra to the tragus. It refers to the sum of the tragus-C7-horizontal angle and the shoulder-C7-horizontal angle; Shoulder-C7-Horizontal Angle (5): The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Shoulder-C7-Horizontal Angle on lateral photography of head posture
时间窗: From enrollment to the end of treatment at 8 weeks
The angle between the line connecting the acromion to the C7 vertebra and the horizontal line emerging from the C7 vertebra level. It refers to the angle of the shoulder.
Quality of Life based on Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire
时间窗: From enrollment to the end of treatment at 8 weeks
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Chronic neck pain intensity
时间窗: Baseline, 2nd week, 4th week, 6th week and 8th 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.
Present neck pain intensity
时间窗: Baseline, 2nd week, 4th week, 6th week and 8th week
Visual Analog Scale. Minimum and maximum values are 0 and 10 cm, respectively. Higher scores mean a worse outcome.
Neck pain intensity at last seven days based on Numeric Pain Rating Scale
时间窗: Baseline, 2nd week, 4th week, 6th week and 8th 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
- Hand grip strength(From enrollment to the end of treatment at 8 weeks)
- Cervical muscle performance(From enrollment to the end of treatment at 8 weeks)
研究者
Harun Gençosmanoğlu
Principal Investigator
Karabuk University