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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07630909
Enrollment
22
Registered
2026-06-05
Start date
2025-09-02
Completion date
2025-09-09
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Syndrome (MPS)

Keywords

Mesotherapy, Myofascial Pain Syndrome, Trigger Points, Intradermal Injection, Non-invasive Treatment

Brief summary

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.

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.

Interventions

PROCEDUREMesotherapy

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

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain AssessmentFrom 4 weeks to 3 monthsPain 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.

Secondary

MeasureTime frameDescription
Change in Maximum Mouth Opening (MMO)Baseline and 4 weeks after treatment initiationMaximum 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

Countries

Egypt

Contacts

STUDY_CHAIRWaleed Fathy Ali Esmael, Professor

Associate Professor of Oral & Maxillofacial Surgery, Future University in Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026