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临床试验/NCT07534540
NCT07534540已完成不适用

Effects of Osteopathic Manipulative Treatment Versus Exercise on Pain, Function, and Dynamic Postural Control in Individuals With Temporomandibular Disorders: A Randomized Controlled Trial

Alanya Alaaddin Keykubat University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Pain Intensity (Visual Analog Scale, VAS)

研究概览

简要总结

The goal of this clinical trial is to evaluate whether different rehabilitation approaches can improve pain, function, and postural control in individuals with temporomandibular disorders (TMD). The study focuses on adults diagnosed with myogenic TMD.

The main questions it aims to answer are:

Does osteopathic manipulative treatment (OMT) reduce pain and improve functional outcomes in individuals with TMD? Does a structured home-based exercise program improve postural control and sensorimotor function in individuals with TMD? Researchers will compare osteopathic manipulative treatment (OMT) and a home-based exercise program to determine their relative effects on pain, function, and postural stability.

Participants will:

Be randomly assigned to either the OMT group or the exercise group Receive the assigned intervention over the study period Undergo assessments before and after treatment, including pain intensity, pressure pain threshold, mandibular movements, cervical range of motion, postural stability, and quality of life

详细描述

Temporomandibular disorders (TMD) are multifactorial conditions characterized by pain, functional limitations, and alterations in sensorimotor control. Although various rehabilitation approaches are commonly used in clinical practice, the relationship between TMD and postural stability remains unclear, particularly regarding the differential effects of specific treatment strategies.

This randomized controlled trial aims to compare the effects of osteopathic manipulative treatment (OMT) and a structured home-based exercise program on pain, functional outcomes, and postural control in individuals with myogenic TMD.

Participants diagnosed with myogenic TMD are randomly allocated to either an OMT group or a home-based exercise group. The OMT intervention consists of manual techniques targeting the temporomandibular joint and related musculoskeletal structures, while the exercise program includes structured therapeutic exercises designed to improve mobility, muscle function, and sensorimotor control.

Outcome measures include pain intensity assessed using the Visual Analog Scale (VAS), pressure pain threshold, mandibular movements, cervical range of motion (ROM), postural stability parameters, and quality of life. All assessments are performed before and after the intervention period by a blinded assessor.

This study is designed to explore whether different rehabilitation approaches produce distinct effects on pain reduction, functional improvement, and postural control, thereby contributing to a better understanding of mechanism-based rehabilitation strategies in TMD.

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)

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

  • Diagnosis of temporomandibular disorder (TMD) confirmed by a dentist
  • Pain intensity ≥ 3.5 cm on the Visual Analog Scale (VAS)
  • Presence of TMD-related pain for at least 3 months
  • Aged between 18 and 50 years
  • Willingness to participate in the study
  • Control Group:
  • No history or clinical signs of temporomandibular disorder (TMD)
  • Aged between 18 and 50 years
  • Willingness to participate in the study

排除标准

  • Presence of any condition other than TMD that may affect the assessment outcomes
  • Presence of musculoskeletal pain in any other body region
  • Any orthopedic or neurological condition that may interfere with assessments
  • Diagnosed psychiatric disorder
  • Conditions impairing communication or ability to complete assessments
  • Illiteracy
  • History of orthopedic surgery in any body region
  • Presence of systemic pathological conditions such as fractures, rheumatoid arthritis, or suspected malingering
  • Receipt of physiotherapy or other treatment targeting the temporomandibular joint or spinal region within the last 6 months
  • Control Group:
  • History of chronic musculoskeletal disorders within the past year
  • Any orthopedic or neurological condition that may interfere with assessments
  • Diagnosed psychiatric disorder
  • Conditions impairing communication or ability to complete assessments
  • Illiteracy

研究组 & 干预措施

OMT Group

Experimental

Participants receive osteopathic manipulative treatment targeting the temporomandibular joint and related structures.

干预措施: Home-based Exercise Program (Behavioral)

OMT Group

Experimental

Participants receive osteopathic manipulative treatment targeting the temporomandibular joint and related structures.

干预措施: Osteopathic Manipulative Treatment (OMT) (Procedure)

Home-Based Exercise Group

Active Comparator

Participants perform a structured home-based exercise program targeting jaw and cervical function.

干预措施: Home-based Exercise Program (Behavioral)

Home-Based Exercise Group

Active Comparator

Participants perform a structured home-based exercise program targeting jaw and cervical function.

干预措施: Osteopathic Manipulative Treatment (OMT) (Procedure)

结局指标

主要结局

Pain Intensity (Visual Analog Scale, VAS)

时间窗: Before intervention and immediately after the intervention period

Pain intensity will be assessed using the Visual Analog Scale (VAS), where participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable).

次要结局

  • Pressure Pain Threshold(Before intervention and immediately after the intervention period)
  • Mandibular Range of Motion(Before intervention and immediately after the intervention period)
  • Cervical Range of Motion(Before intervention and immediately after the intervention period)
  • Postural Stability(Before intervention and immediately after the intervention period)
  • Quality of Life (Short Form-12, SF-12)(Before intervention and immediately after the intervention period)
  • Quality of Life (Short Form-12 Health Survey, SF-12)(Before intervention and immediately after the intervention period)

研究者

发起方
Alanya Alaaddin Keykubat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayça Araci

Assistant Proffesor

Alanya Alaaddin Keykubat University

研究点 (1)

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