Mesotherapy for the Management of Myofascial Pain Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome (MPS)
• Intervention / Treatment: Procedure: Mesotherapy; Procedure: trigger point injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Mesotherapy; 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; Procedure: trigger point injection; 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
Active Comparator: 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.	Procedure: Mesotherapy; 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; Procedure: trigger point injection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Mouth Opening (MMO)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality-of-Life (QoL)	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	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

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Investigators: Study Chair: Waleed Fathy Ali Esmael, Professor, Associate Professor of Oral & Maxillofacial Surgery, Future University in Egypt

Publications and helpful links

General Publications

• 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.

Helpful Links

• Mesotherapy effectiveness in temporomandibular joint disorders
• Clinical evaluation of mesotherapy effectiveness in treating myofascial pain syndrome
• Review of mesotherapy in facial pain management
• Risk factors for temporomandibular disorders: a systematic review of cohort studies.
• Diagnostic and therapeutic insights into temporomandibular joint disorders
• Pain management in TMJ disorders-recent advances

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Actual): September 7, 2025
• Study Completion (Actual): September 9, 2025

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Mesotherapy; Trigger Points; Myofascial Pain Syndrome; Intradermal Injection; Non-invasive Treatment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Myofascial Pain Syndromes; Therapeutics; Drug Administration Routes; Drug Therapy; Complementary Therapies; Injections; Cosmetic Techniques; Injections, Subcutaneous; Mesotherapy
• Other Study ID Numbers: Myofascial Pain Syndrome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No