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临床试验/NCT07210957
NCT07210957已完成不适用

The Effect of Manual Therapy in Individuals With Temporomandibular Disorders

Abant Izzet Baysal University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Ultrasound Assessment

研究概览

简要总结

Temporomandibular disorders (TMD) are multifactorial conditions involving the temporomandibular joint and masticatory muscles, often presenting with pain and functional limitations. Conventional management includes splints, pharmacological approaches, physiotherapy, and manual therapy. This study aims to evaluate the effects of manual therapy compared to therapeutic exercise on muscle thickness, pain pressure threshold, range of motion, pain, mandibular function, and anxiety in individuals with TMD.

详细描述

TMD affects approximately one-quarter of the population and is characterized by pain, restricted movement, and impaired mandibular function. Etiology is multifactorial, including occlusal issues, trauma, bruxism, stress, and postural alterations. Bruxism in particular contributes to repetitive loading and hypertonia of the masticatory and cervical muscles, potentially influencing global posture. Current treatment approaches range from occlusal splints and surgery to conservative physiotherapy, manual therapy, and exercise. While manual therapy may reduce pain and restore mobility through techniques such as joint mobilization, myofascial release, and muscle inhibition, exercise supports improvements in strength, endurance, coordination, and joint stability. Evidence suggests that combined approaches may provide additive benefits. This trial will compare manual therapy and therapeutic exercise interventions in patients with TMD over six weeks. Objective outcomes will include ultrasound-based muscle thickness, pain pressure threshold, mandibular range of motion, pain intensity, and mandibular function. Anxiety levels will also be assessed using validated questionnaires. The primary hypothesis is that manual therapy will produce greater improvements across these measures compared to exercise.

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 (Participant, Outcomes Assessor)

盲法说明

Group allocation was concealed from participants, and outcome assessment was performed by a researcher who was blinded to group allocation.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Myalgia, and both myalgia and arthralgia according to Diagnostic Criteria for Temporomandibular Disorders
  • Completing signing the informed consent form

排除标准

  • Any rheumatological or metabolic disease
  • Receiving any treatment for temporomandibular joint in the last 2 years (such as botulinum toxin, manual therapy, splint, orthodontics)
  • A history of traumatic temporomandibular joint
  • A history of diagnosed psychological diseases

结局指标

主要结局

Ultrasound Assessment

时间窗: Baseline, sixth week

Muscle thickness of the masseter and temporalis will be measured with a linear probe in neutral rest and during submaximal teeth clenching (supine). The probe will be aligned to standard anatomical landmarks, kept perpendicular to the skin without compressing soft tissue. Thickness will be recorded in millimeters as the distance between the internal and external fascia. Each muscle will be assessed once per condition.

次要结局

  • Pain Pressure Threshold(Baseline, sixth week)
  • Maximum Mouth Opening and Lateral Excursion(Baseline, sixth week)
  • Mandibular Function Scale(Baseline, sixth week)
  • State-Trait Anxiety Inventory(Baseline, sixth week)
  • Generalized Anxiety Disorder Scale(Baseline, sixth week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ramazan KURUL

Assoc. Prof

Abant Izzet Baysal University

研究点 (2)

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