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
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2025
CompletedFirst Submitted
Initial submission to the registry
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedJune 5, 2026
June 1, 2026
5 days
April 1, 2026
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in Maximum Mouth Opening (MMO)
Baseline and 4 weeks after treatment initiation
Other Outcomes (2)
Change in Quality-of-Life (QoL)
Baseline, 4 weeks, and 3 months
Patient Satisfaction
End of treatment (4 weeks) and 3-month follow-up
Study Arms (2)
Mesotherapy Group
EXPERIMENTALParticipants 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.
Trigger Point Injection Group
ACTIVE COMPARATORParticipants 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- patients between 18 - 60 years.
- Patients who had a Diagnosis of TMD, with chronic pain, muscle spasms, myofascial pain syndrome lasting at least 3 months, and challenges while chewing.
- Patients who have difficulty opening their mouths, cases where conservative treatment methods (physical, medical, or appliances) have failed.
- Patients who have Bruxism -
You may not qualify if:
- Systemic Diseases such as uncontrolled Diabetes, uncontrolled hypertension disorders of coagulation (hemophiliacs, undergoing therapy with anticoagulants or antiplatelet agents, and cancer patients undergoing chemotherapy.
- Patients with a history of Muscular dystrophies, Myasthenia Gravis, Polymyositis, Rheumatoid arthritis, Hypothyroidism, and Sarcoidosis
- Patients with active Infections around the injection site.
- Females who are pregnant or breastfeeding are excluded.
- A patient who had a history of severe mental health disorders or neurological conditions affecting pain perception or compliance.
- Patients with allergies to the components used in mesotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Oral and Dental Medicine, Future University in Egypt
New Cairo, Cairo Governorate, 4740011, Egypt
Related Publications (1)
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.
RESULT
Related 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Waleed Fathy Ali Esmael, Professor
Associate Professor of Oral & Maxillofacial Surgery, Future University in Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher of Oral and Dental Medicine
Study Record Dates
First Submitted
April 1, 2026
First Posted
June 5, 2026
Study Start
September 2, 2025
Primary Completion
September 7, 2025
Study Completion
September 9, 2025
Last Updated
June 5, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share