Myofascial Pain Syndrome (MPS)NCT07630909
Mesotherapy for the Management of Myofascial Pain Syndrome
A study testing Mesotherapy and trigger point injection in people with Myofascial Pain Syndrome (MPS), run by Future University in Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myofascial Pain Syndrome (MPS)
- What is being tested?
- Mesotherapy and trigger point injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2025to 9 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine, Future University in Egypt
New Cairo, Cairo Governorate, 4740011
About this study
Official title: 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.
Read the 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.
- Conditions
- Myofascial Pain Syndrome (MPS)
- Being tested
- Mesotherapy, trigger point injection
- Keywords
- Mesotherapy, Myofascial Pain Syndrome, Trigger Points, Intradermal Injection, Non-invasive Treatment
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesotherapyProcedure or surgery
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 injectionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Mesotherapy Group | Experimental | 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. Receives: Procedure: Mesotherapy; Procedure: trigger point injection |
| Trigger Point Injection Group | Active comparator | 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. Receives: Procedure: Mesotherapy; Procedure: trigger point injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 4 weeks to 3 months
Secondary outcomes (1)
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
Measured: Baseline and 4 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start2 Sep 2025
- Primary completion7 Sep 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain Syndrome (MPS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Ali, Future University in Egypt
- Investigators
- Waleed Fathy Ali Esmael, Professor, Study chair, Associate Professor of Oral & Maxillofacial Surgery, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630909
- Sponsor's protocol ID
- Myofascial Pain Syndrome
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Assessment of Mesotherapy as A Therapeutic Intervention for Myofascial Pain Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07630909
- Acronym / sponsor ID
- Myofascial Pain Syndrome
- Conditions
- Myofascial Pain Syndrome (MPS)
- Keywords
- Mesotherapy, Myofascial Pain Syndrome, Trigger Points, Intradermal Injection, Non-invasive Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 7 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesotherapy Group | Experimental | Procedure: Mesotherapy, Procedure: trigger point injectionParticipants 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 comparator | Procedure: Mesotherapy, Procedure: trigger point injectionParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesotherapyMesotherapy 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 or surgery | Mesotherapy Group, Trigger Point Injection Group |
| trigger point injectionTrigger 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 | Procedure or surgery | Mesotherapy Group, Trigger Point Injection Group |
Primary outcome
Pain Assessment
Time frame: 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.
1 secondary outcome
Change in Maximum Mouth Opening (MMO)
Time frame: Baseline and 4 weeks after treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Results publicationCruz 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.
- Mesotherapy effectiveness in temporomandibular joint disordersLink provided by the sponsor.
- Risk factors for temporomandibular disorders: a systematic review of cohort studies.Link provided by the sponsor.
- Diagnostic and therapeutic insights into temporomandibular joint disordersLink provided by the sponsor.
- Pain management in TMJ disorders-recent advancesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed Fathy Ali Esmael, Professor study chair
Associate Professor of Oral & Maxillofacial Surgery, Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesotherapy and trigger point injection in people with Myofascial Pain Syndrome (MPS), run by Future University in Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: From 4 weeks to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07630909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.