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临床试验/NCT07676799
NCT07676799已完成不适用

Ultrasonographic Assessment of Treatment-Induced Echogenicity Changes in Masticatory and Cervical Muscles in Patients With Myofascial Pain

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年5月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
The change of the pain score

研究概览

简要总结

Myofascial pain is one of the most important symptoms in patients with temporomandibular disorders (TMD). Although the etiological factors leading to TMD have not been definitively established, parafunctional habits such as bruxism and clenching, as well as conditions such as stress and anxiety, are thought to contribute to inflammation of the joint capsule and to muscle spasm and pain in the masticatory muscles. This condition is defined as a clinical entity affecting a significant proportion of patients and may result in pain and hypertrophy of the masticatory muscles.

One of the key clinical findings of myofascial pain is the presence of trigger points, which induce pain perception and involve the sensory component of sensitized nociceptors. Muscle tenderness on palpation is an important clinical finding in the diagnosis of masticatory system dysfunctions and can be observed in approximately 90% of patients.

In ultrasonography, echogenicity refers to the ability of tissues to reflect sound waves and varies depending on differences in acoustic impedance between tissues; as impedance differences increase, echogenicity also increases. In muscle tissue, internal structure can be evaluated based on the visibility and density of intramuscular echogenic bands. In the presence of inflammation, edema, or intramuscular structural changes, a decrease in the number of these echogenic bands, loss of their definition, and alterations in internal echogenicity may be observed. Therefore, ultrasonography is a valuable imaging method not only for evaluating muscle thickness but also for assessing internal structural characteristics and treatment-related changes.

Posterior cervical muscles include the trapezius, longissimus, sternocleidomastoid (SCM), splenius, and levator scapulae muscles. Although these muscles do not directly affect mandibular movement, they may become symptomatic in the presence of TMD and can refer pain to the facial region. For this reason, their palpation is routinely performed during clinical examination. The trapezius muscle is a large and easily palpable muscle located in the back, shoulder, and neck region, which does not directly affect jaw function but may contribute to widespread headache. The primary purpose of its palpation during examination is not to assess shoulder function, but to identify active trigger points that may cause referred pain. The sternocleidomastoid (SCM) muscle plays an important role in head posture and movement. It can be palpated along its entire length, including its lower portion near the clavicle. Trigger points in this muscle may cause referred pain to the temple, temporomandibular joint, and ear region.

The treatment of myofascial pain is complex and generally varies according to the severity of symptoms and clinical presentation. Primary treatment options include occlusal splint therapy, supportive exercises, stress and anxiety reduction approaches, muscle exercises, postural modifications, pharmacological treatments (nonsteroidal anti-inflammatory drugs, muscle relaxants, benzodiazepines, selective serotonin reuptake inhibitors), and symptom-oriented interventions such as acupuncture. In addition, local anesthetic injections without vasoconstrictors may be applied to trigger points. Lidocaine injections into the muscles have been reported to contribute to pain control by reducing muscle activity and pain mediators.

The present study aims to evaluate the effects of occlusal splint therapy and lidocaine injection on the masseter, trapezius, and sternocleidomastoid muscles in patients diagnosed with myofascial pain, by analyzing internal echogenicity measurements obtained from archived ultrasonographic images.

详细描述

Patients presenting to our clinic with pain and tenderness in the perimandibular and temporomandibular regions during rest and/or function will undergo a temporomandibular joint examination, together with palpation of the trapezius and sternocleidomastoid (SCM) muscles.

A total of 40 patients will be randomly allocated into two groups. Twenty patients will receive occlusal splint therapy, and twenty patients will receive lidocaine injection therapy.

Ultrasonographic images of the masseter, trapezius, and sternocleidomastoid muscles will be obtained before treatment and at the 3-month follow-up in both treatment groups.

In addition, 20 healthy individuals without any symptoms and with normal temporomandibular joint examination findings will be included as the control group.

These ultrasonographic images will be used to evaluate the internal echogenicity of the examined muscles.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The investigator performing the ultrasonographic examinations and the investigator responsible for data analysis were blinded to the group allocation of the participants. The patients' treatment assignments were not disclosed to these assessors throughout the study period.

入排标准

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

入选标准

  • •No medical or surgical treatment for temporomandibular disorders within the last 3 months; Diagnosis of myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic decision tree; Presence of at least three trigger points (active or latent) in the masseter muscles on palpation; No missing teeth other than third molars; No history of occlusal splint therapy; No previous masticatory muscle injections or dry needling.

排除标准

  • •Intra-articular disorders or degenerative joint disease according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic decision tree; Known allergy to local anesthetics; Presence of malignancy or history of head and neck radiotherapy or chemotherapy within the last 2 years; Presence of a bleeding disorder; Pregnancy or lactation; Drug and/or alcohol abuse; Active orthodontic treatment.

研究组 & 干预措施

Occlusal Splint Group

Active Comparator

occlusal splint was made for this patients.

干预措施: occlusal splint (Device)

masseter muscle injection group

Active Comparator

IPatients in this group received intramuscular lidocaine injections into the masseter muscle trigger points. A total of 0.3 mL of Lidocaine Hydrochloride (20 mg/mL, Jetokain Simplex, ADEKA, Samsun, Türkiye) was injected into each trigger point.

干预措施: Lidocaine Hydrochloride 2% Injection Solution (Drug)

Control group

No Intervention

Forty healthy volunteers were included as the control group and did not receive any treatment.

结局指标

主要结局

The change of the pain score

时间窗: Before treatment (Day 0) and at 3 months after treatment initiation

Severity of the pain evaluated by the visual analog scale (VAS), rated from 0 (no pain) to 10 (the worst pain)

Internal Structure of muscles

时间窗: Before the treatment (day 0), and 3rd months of the treatment

Internal muscle structure was classified based on the visibility and width of intramuscular echogenic bands corresponding to muscle fibers.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

reyhan saglam-dogu

Assistant Professor, Department of Oral and Maxillofacial Surgery, Principal Investigator

Istanbul Medipol University Hospital

研究点 (1)

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