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Mesotherapy for the Management of Myofascial Pain Syndrome

2026年6月3日 更新者:Basma Ali、Future University in Egypt

A Clinical Assessment of Mesotherapy as A Therapeutic Intervention for Myofascial Pain Syndrome: A Randomized Controlled Trial

Temporomandibular joint disorders represent a complex and heterogeneous group of musculoskeletal conditions affecting the temporomandibular joint,masticatory muscles, and associated structures, frequently manifesting as chronic orofacial pain.

Temporomandibular joint (TMJ) disorders encompass a group of conditions affecting the jaw joint and associated musculature, leading to pain, impaired function, and a diminished quality of life. These disorders arise from various etiologies, including trauma,degenerative conditions such as osteoarthritis, and systemic inflammatory diseases, emphasizing their multifactorial nature.

Although the mechanism of action of mesotherapy in TMJ disorders involves delivering anti-inflammatory and analgesic agents directly to the affected area,the literature reveals a significant research gap regarding its efficacy and longterm benefits.

研究概览

详细说明

The temporomandibular joints (TMJs) are among the most frequently used joints in the body, opening and closing approximately 2,000 times a day. These joints are essential for various critical activities, including verbal and nonverbal communication, the challenging movements involved in chewing, and even the more subtle action of breathing. Healthy functioning of both the TMJs and the surrounding tissues is crucial for these activities. Additionally, the joints play a vital role in interpersonal interactions and contribute to facial expressions that convey emotions such as joy or sadness, as well as impacting self-esteem and self-identity.

Temporomandibular disorders are recognized as the most common chronic orofacial pain condition, with no significant differences found between racial groups. As previously defined, TMD refers to a group of pain conditions and dysfunctions, and not all epidemiological studies have used the same classification or differentiated between muscle and joint disorders. Indeed,inclusion criteria employed in studies before modern classifications encompassed some disorders into one entity.

This questions the validity of much of the epidemiologic research performed before criteria and diagnoses were standardized. This prevalence highlights the widespread impact of these conditions and underscores the critical need for effective diagnostic and therapeutic strategies.

The pathophysiology of TMJ disorders is complex, involving factors such as mechanical stress, inflammation, and genetic predisposition. These disorders typically affect the masticatory muscles, the TMJ itself, and the dentition,reflecting their multifaceted nature.

Management of TMJ disorders often requires a multidisciplinary approach,incorporating both conservative and invasive treatments tailored to the condition's severity and underlying causes.Among conservative treatments, mesotherapy has gained attention as a minimally invasive technique. This method involves intradermal or subcutaneous injections of pharmacological agents. The localized delivery allows for a timereleased therapeutic effect, minimizing systemic exposure.

The trigger points, the most sensitive points within a contracted muscle band,elicit pain upon compression and may be accompanied by referred pain. These points are considered active or latent based on their clinical characteristics.Active trigger points cause spontaneous pain and alter sensations in predictable pain patterns associated with that specific muscle. Latent trigger points, on the other hand, do not cause spontaneous pain but can restrict movement or cause muscle weakness. Myofascial pain is often misdiagnosed because the trigger point causing pain is often distant to where the pain is felt.

Mesotherapy has been used in managing various musculoskeletal conditions,including TMJ disorders, due to its potential to target underlying inflammatory processes. By modulating inflammation, mesotherapy may reduce pain and enhance joint functionality, aligning with the current focus on personalized, localized therapies. Some studies have reported positive outcomes, such as reduced pain and improved range of motion in patients with TMJ disorders.

研究类型

介入性

注册 (实际的)

22

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Cairo Governorate
      • New Cairo、Cairo Governorate、埃及、4740011
        • Faculty of Oral and Dental Medicine, Future University in Egypt

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. patients between 18 - 60 years.
  2. Patients who had a Diagnosis of TMD, with chronic pain, muscle spasms, myofascial pain syndrome lasting at least 3 months, and challenges while chewing.
  3. Patients who have difficulty opening their mouths, cases where conservative treatment methods (physical, medical, or appliances) have failed.
  4. Patients who have Bruxism -

Exclusion Criteria:

  1. Systemic Diseases such as uncontrolled Diabetes, uncontrolled hypertension disorders of coagulation (hemophiliacs, undergoing therapy with anticoagulants or antiplatelet agents, and cancer patients undergoing chemotherapy.
  2. Patients with a history of Muscular dystrophies, Myasthenia Gravis, Polymyositis, Rheumatoid arthritis, Hypothyroidism, and Sarcoidosis
  3. Patients with active Infections around the injection site.
  4. Females who are pregnant or breastfeeding are excluded.
  5. A patient who had a history of severe mental health disorders or neurological conditions affecting pain perception or compliance.
  6. Patients with allergies to the components used in mesotherapy.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Mesotherapy Group
Participants in this group will receive mesotherapy injections into the affected muscle areas following a standardized protocol. Small doses of mixed medications (such as lidocaine and anti-inflammatory agents) will be injected intradermally around the trigger points once weekly for 4 weeks. The aim is to achieve localized pain relief, improved microcirculation, and better muscle function.
Mesotherapy involves the administration of very small doses of medications into the superficial layer of the skin over the painful muscle area. The injected solution typically contains lidocaine and anti-inflammatory agents. In this study, mesotherapy will be performed once weekly for four weeks using multiple superficial intradermal microinjections around the trigger points to reduce pain, improve local blood flow, and restore muscle function
Trigger point injection (TPI) consists of the direct intramuscular injection of a local anesthetic, such as lidocaine, hydrocortisone and ketolac into identified myofascial trigger points. The procedure aims to deactivate painful trigger points, relieve muscle spasm, and reduce referred pain. In this study, injections will be administered once weekly for four weeks using a standardized technique to ensure consistency and safety
有源比较器:Trigger Point Injection Group
Participants in this group will receive conventional trigger point injections (TPI) using a local anesthetic directly into the identified trigger points. The injections will be administered once weekly for 4 weeks to relieve muscle tension and pain.
Mesotherapy involves the administration of very small doses of medications into the superficial layer of the skin over the painful muscle area. The injected solution typically contains lidocaine and anti-inflammatory agents. In this study, mesotherapy will be performed once weekly for four weeks using multiple superficial intradermal microinjections around the trigger points to reduce pain, improve local blood flow, and restore muscle function
Trigger point injection (TPI) consists of the direct intramuscular injection of a local anesthetic, such as lidocaine, hydrocortisone and ketolac into identified myofascial trigger points. The procedure aims to deactivate painful trigger points, relieve muscle spasm, and reduce referred pain. In this study, injections will be administered once weekly for four weeks using a standardized technique to ensure consistency and safety

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pain Assessment
大体时间:From 4 weeks to 3 months
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their pain before the first treatment and after completion of the 4-week treatment period.
From 4 weeks to 3 months

次要结果测量

结果测量
措施说明
大体时间
Change in Maximum Mouth Opening (MMO)
大体时间:Baseline and 4 weeks after treatment initiation
Maximum mouth opening (MMO) will be measured as the distance between the incisal edges of the upper and lower central incisors using a calibrated digital caliper. Measurements will be taken at baseline and after completion of the 4-week treatment period. An increase in MMO indicates improved jaw function and reduction in myofascial pain-related muscle restriction. The mean change in MMO between the mesotherapy and trigger point injection groups will be compared
Baseline and 4 weeks after treatment initiation

其他结果措施

结果测量
措施说明
大体时间
Change in Quality-of-Life (QoL)
大体时间:Baseline, 4 weeks, and 3 months

Change in Quality of Life Measured by Oral Health Impact Profile (OHIP-14) Quality of life will be assessed using the Oral Health Impact Profile (OHIP-14) questionnaire.

The OHIP-14 consists of 14 items with scores ranging from 0 to 56, where higher scores indicate worse quality of life.

Assessments will be performed at baseline, after the 4-week treatment period, and at 3-month follow-up. Mean changes between groups will be compared.

Baseline, 4 weeks, and 3 months
Patient Satisfaction
大体时间:End of treatment (4 weeks) and 3-month follow-up

Patient satisfaction will be assessed using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction.

Assessments will be performed at the end of the 4-week treatment period and at the 3-month follow-up.

Time

End of treatment (4 weeks) and 3-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Waleed Fathy Ali Esmael, Professor、Associate Professor of Oral & Maxillofacial Surgery, Future University in Egypt

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • Cruz AP, Oliveira A, Martins J, Santos P, et al. Effectiveness of mesotherapy on temporomandibular joint disorders. Journal of Physical Science and Application. 2015;5(4):249-254.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月2日

初级完成 (实际的)

2025年9月7日

研究完成 (实际的)

2025年9月9日

研究注册日期

首次提交

2026年4月1日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年6月5日

上次提交的符合 QC 标准的更新

2026年6月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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