Comparative Effects of Manual Therapy Versus Home Exercise on Pain, Function, and Masseter Muscle Properties in Myogenic Temporomandibular Disorder With Neck Pain: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 主要终点
- Temporomandibular Joint Pain Intensity at Rest, During Activity, and During Chewing Assessed by Visual Analog Scale (VAS).
研究概览
简要总结
Temporomandibular disorders (TMD) are common musculoskeletal conditions affecting the jaw joint and surrounding chewing muscles. Myogenic TMD specifically involves muscle pain and dysfunction, which is frequently accompanied by chronic neck pain due to the close anatomical and neurophysiological connections between the jaw and the cervical spine.
The purpose of this study is to compare the clinical effectiveness of two widely used physiotherapy interventions-a clinician-administered manual therapy protocol and a patient-conducted home exercise program-in individuals diagnosed with myogenic TMD and chronic neck pain. The main research question is to determine whether targeted manual therapy applied to both the temporomandibular and cervical regions yields superior improvements in pain, jaw and neck mobility, quality of life, and masseter muscle properties compared to the Rocabado 6x6 home exercise program alone.
- A total of 34 participants aged 18-45 years with myogenic TMD and chronic neck pain will be randomly allocated into two equal groups:
Manual Therapy Group: Participants receive 6 individual treatment sessions (3 days per week for 2 weeks) consisting of soft tissue mobilization, trigger point therapy, myofascial release, and joint mobilization techniques applied to the jaw and neck regions. 2. Exercise Group: Participants perform the standardized Rocabado 6x6 home exercise program 3 days per week for 2 weeks, with adherence monitored through daily exercise diaries.
All participants undergo comprehensive assessments at baseline and immediately following the 2-week intervention. Evaluated parameters include jaw and neck pain intensity (Visual Analog Scale), cervical and mandibular range of motion, cervical joint position sense, jaw proprioception, facial asymmetry, bruxism, TMD severity, movement-related fear (kinesiophobia), and quality of life. In addition, masseter muscle thickness and elasticity are objectively assessed using ultrasound imaging and elastography.
The findings of this trial aim to provide healthcare professionals with high-level evidence regarding effective, targeted physiotherapy strategies for managing myogenic TMD co-occurring with cervical pain.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The outcome assessor conducting baseline and post-treatment clinical and ultrasonographic evaluations is blinded to participant group allocations. Due to the nature of manual therapy and exercise interventions, participants and treating physiotherapists cannot be blinded. Data analysts and investigators involved in outcome calculations are also blinded to group assignments.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of TMJ pain at rest,
- •TMJ pain persisting for at least 3 months,
- •Neck pain persisting for at least 3 months,
- •Willingness to participate in the study.
排除标准
- •Any orthopedic and/or neurological condition that would preclude the assessments,
- •Cardiac history or surgery severe enough to preclude exercise,
- •Diagnosis of any psychiatric disorder,
- •Any condition precluding assessment or communication,
- •History of orthopedic surgery in any region,
- •Receipt of physiotherapy or any other treatment for the TMJ or spinal region within the previous 6 months,
- •Illiteracy,
- •A positive vertebrobasilar artery test.
研究组 & 干预措施
Manual Therapy Group
干预措施: Manual Therapy Protocol (Procedure)
Rocabado Home Exercise Group
干预措施: Rocabado 6x6 Home Exercise Program (Other)
结局指标
主要结局
Temporomandibular Joint Pain Intensity at Rest, During Activity, and During Chewing Assessed by Visual Analog Scale (VAS).
时间窗: Baseline and Week 2, immediately post-treatment
Title: Neck Pain Intensity Assessed by Visual Analog Scale (VAS).
时间窗: Baseline and 2 weeks post-treatment
次要结局
- Cervical Spine Active Range of Motion Assessed by Baseline CROM Deluxe Device.(Baseline and 2 weeks post-treatmen)
- Cervical Joint Position Error Assessed by Baseline CROM Deluxe Device(Baseline and 2 weeks post-treatmen)
- Mandibular Range of Motion Assessed by Digital Caliper(Baseline and 2 weeks post-treatment)
- Jaw Proprioception Assessed by Active Movement Extent Discrimination Apparatus (AMEDA) Protocol.(Baseline and 2 weeks post-treatment)
- Facial Asymmetry Assessed by Tape Measure(Baseline and 2 weeks post-treatment)
- Kinesiophobia Assessed by Tampa Scale for Kinesiophobia for Temporomandibular Disorders - Short Form (TSK-TMD-12).(Baseline and 2 weeks post-treatment)
- Health-Related Quality of Life Assessed by 12-Item Short Form Survey (SF-12).(Baseline and 2 weeks post-treatment)
- Self-Reported Awake and Sleep Bruxism Assessed by Patient Questionnaire.(Baseline and 2 weeks post-treatment)
- Temporomandibular Disorder Severity Assessed by the Fonseca Anamnestic Index (FAI) / Fonseca Questionnaire.(Baseline and 2 weeks post-treatment)
- Bilateral Masseter Muscle Thickness Assessed by Ultrasonography.(Baseline and 2 weeks post-treatment)
研究者
Borna Farhoomand
Physiotherapist
Pamukkale University