Myofascial PainUAMEMPNCT07676799
Ultrasonographic Assessment of Muscle Echogenicity in Myofascial Pain
A study testing occlusal splint and Lidocaine Hydrochloride 2% Injection Solution in people with Myofascial Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Myofascial pain is one of the most important symptoms in patients with temporomandibular disorders (TMD). Although the etiological factors leading to TMD have not been definitively established, parafunctional habits such as bruxism and clenching, as well as conditions such as stress and anxiety, are thought to… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain
- What is being tested?
- occlusal splint and Lidocaine Hydrochloride 2% Injection Solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2026to 30 Jul 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No medical or surgical treatment for temporomandibular disorders within the last 3 months; Diagnosis of myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic decision tree; Presence of at least three trigger points (active or latent) in the masseter muscles on palpation; No missing teeth other than third molars; No history of occlusal splint therapy; No previous masticatory muscle injections or dry needling.
Who cannot join
- Intra-articular disorders or degenerative joint disease according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic decision tree; Known allergy to local anesthetics; Presence of malignancy or history of head and neck radiotherapy or chemotherapy within the last 2 years; Presence of a bleeding disorder; Pregnancy or lactation; Drug and/or alcohol abuse; Active orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Assessment of Treatment-Induced Echogenicity Changes in Masticatory and Cervical Muscles in Patients With Myofascial Pain
Myofascial pain is one of the most important symptoms in patients with temporomandibular disorders (TMD). Although the etiological factors leading to TMD have not been definitively established, parafunctional habits such as bruxism and clenching, as well as conditions such as stress and anxiety, are thought to contribute to inflammation of the joint capsule and to muscle spasm and pain in the masticatory muscles. This condition is defined as a clinical entity affecting a significant proportion of patients and may result in pain and hypertrophy of the masticatory muscles.
One of the key clinical findings of myofascial pain is the presence of trigger points, which induce pain perception and involve the sensory component of sensitized nociceptors. Muscle tenderness on palpation is an important clinical finding in the diagnosis of masticatory system dysfunctions and can be observed in approximately 90% of patients.
Read more
In ultrasonography, echogenicity refers to the ability of tissues to reflect sound waves and varies depending on differences in acoustic impedance between tissues; as impedance differences increase, echogenicity also increases. In muscle tissue, internal structure can be evaluated based on the visibility and density of intramuscular echogenic bands. In the presence of inflammation, edema, or intramuscular structural changes, a decrease in the number of these echogenic bands, loss of their definition, and alterations in internal echogenicity may be observed. Therefore, ultrasonography is a valuable imaging method not only for evaluating muscle thickness but also for assessing internal structural characteristics and treatment-related changes.
Posterior cervical muscles include the trapezius, longissimus, sternocleidomastoid (SCM), splenius, and levator scapulae muscles. Although these muscles do not directly affect mandibular movement, they may become symptomatic in the presence of TMD and can refer pain to the facial region. For this reason, their palpation is routinely performed during clinical examination. The trapezius muscle is a large and easily palpable muscle located in the back, shoulder, and neck region, which does not directly affect jaw function but may contribute to widespread headache. The primary purpose of its palpation during examination is not to assess shoulder function, but to identify active trigger points that may cause referred pain. The sternocleidomastoid (SCM) muscle plays an important role in head posture and movement. It can be palpated along its entire length, including its lower portion near the clavicle. Trigger points in this muscle may cause referred pain to the temple, temporomandibular joint, and ear region.
The treatment of myofascial pain is complex and generally varies according to the severity of symptoms and clinical presentation. Primary treatment options include occlusal splint therapy, supportive exercises, stress and anxiety reduction approaches, muscle exercises, postural modifications, pharmacological treatments (nonsteroidal anti-inflammatory drugs, muscle relaxants, benzodiazepines, selective serotonin reuptake inhibitors), and symptom-oriented interventions such as acupuncture. In addition, local anesthetic injections without vasoconstrictors may be applied to trigger points. Lidocaine injections into the muscles have been reported to contribute to pain control by reducing muscle activity and pain mediators.
The present study aims to evaluate the effects of occlusal splint therapy and lidocaine injection on the masseter, trapezius, and sternocleidomastoid muscles in patients diagnosed with myofascial pain, by analyzing internal echogenicity measurements obtained from archived ultrasonographic images.
Read the detailed description
Patients presenting to our clinic with pain and tenderness in the perimandibular and temporomandibular regions during rest and/or function will undergo a temporomandibular joint examination, together with palpation of the trapezius and sternocleidomastoid (SCM) muscles.
A total of 40 patients will be randomly allocated into two groups. Twenty patients will receive occlusal splint therapy, and twenty patients will receive lidocaine injection therapy.
Ultrasonographic images of the masseter, trapezius, and sternocleidomastoid muscles will be obtained before treatment and at the 3-month follow-up in both treatment groups.
In addition, 20 healthy individuals without any symptoms and with normal temporomandibular joint examination findings will be included as the control group.
These ultrasonographic images will be used to evaluate the internal echogenicity of the examined muscles.
- Conditions
- Myofascial Pain
- Being tested
- occlusal splint, Lidocaine Hydrochloride 2% Injection Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal splintDevice
Patients in this group were treated with an occlusal splint.
Lidocaine Hydrochloride 2% Injection SolutionDrug
0,3 mlLidocaine Hydrochloride was injected to all trigger points.
| Study group | Role | What they receive |
|---|---|---|
| Occlusal Splint Group | Active comparator | occlusal splint was made for this patients. Receives: Device: occlusal splint |
| masseter muscle injection group | Active comparator | IPatients in this group received intramuscular lidocaine injections into the masseter muscle trigger points. A total of 0.3 mL of Lidocaine Hydrochloride (20 mg/mL, Jetokain Simplex, ADEKA, Samsun, Türkiye) was injected into each trigger point. Receives: Drug: Lidocaine Hydrochloride 2% Injection Solution |
| Control group | No intervention | Forty healthy volunteers were included as the control group and did not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the pain score
Severity of the pain evaluated by the visual analog scale (VAS), rated from 0 (no pain) to 10 (the worst pain)
Measured: Before treatment (Day 0) and at 3 months after treatment initiation
Internal Structure of muscles
Internal muscle structure was classified based on the visibility and width of intramuscular echogenic bands corresponding to muscle fibers.
Measured: Before the treatment (day 0), and 3rd months of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start16 May 2026
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A prospective randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reyhan saglam-dogu, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676799
- Sponsor's protocol ID
- 749
- Acronym
- UAMEMP
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Treatment-Induced Echogenicity Changes in Masticatory and Cervical Muscles in Patients With Myofascial Pain
- ClinicalTrials.gov ID
- NCT07676799
- Acronym / sponsor ID
- UAMEMP / 749
- Conditions
- Myofascial Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 16 May 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 30 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.
Myofascial pain is one of the most important symptoms in patients with temporomandibular disorders (TMD). Although the etiological factors leading to TMD have not been definitively established, parafunctional habits such as bruxism and clenching, as well as conditions such as stress and anxiety, are thought to contribute to inflammation of the joint capsule and to muscle spasm and pain in the masticatory muscles. This condition is defined as a clinical entity affecting a significant proportion of patients and may result in pain and hypertrophy of the masticatory muscles.
One of the key clinical findings of myofascial pain is the presence of trigger points, which induce pain perception and involve the sensory component of sensitized nociceptors. Muscle tenderness on palpation is an important clinical finding in the diagnosis of masticatory system dysfunctions and can be observed in approximately 90% of patients.
In ultrasonography, echogenicity refers to the ability of tissues to reflect sound waves and varies depending on differences in acoustic impedance between tissues; as impedance differences increase, echogenicity also increases. In muscle tissue, internal structure can be evaluated based on the visibility and density of intramuscular echogenic bands. In the presence of inflammation, edema, or intramuscular structural changes, a decrease in the number of these echogenic bands, loss of their definition, and alterations in internal echogenicity may be observed. Therefore, ultrasonography is a valuable imaging method not only for evaluating muscle thickness but also for assessing internal structural characteristics and treatment-related changes.
Posterior cervical muscles include the trapezius, longissimus, sternocleidomastoid (SCM), splenius, and levator scapulae muscles. Although these muscles do not directly affect mandibular movement, they may become symptomatic in the presence of TMD and can refer pain to the facial region. For this reason, their palpation is routinely performed during clinical examination. The trapezius muscle is a large and easily palpable muscle located in the back, shoulder, and neck region, which does not directly affect jaw function but may contribute to widespread headache. The primary purpose of its palpation during examination is not to assess shoulder function, but to identify active trigger points that may cause referred pain. The sternocleidomastoid (SCM) muscle plays an important role in head posture and movement. It can be palpated along its entire length, including its lower portion near the clavicle. Trigger points in this muscle may cause referred pain to the temple, temporomandibular joint, and ear region.
The treatment of myofascial pain is complex and generally varies according to the severity of symptoms and clinical presentation. Primary treatment options include occlusal splint therapy, supportive exercises, stress and anxiety reduction approaches, muscle exercises, postural modifications, pharmacological treatments (nonsteroidal anti-inflammatory drugs, muscle relaxants, benzodiazepines, selective serotonin reuptake inhibitors), and symptom-oriented interventions such as acupuncture. In addition, local anesthetic injections without vasoconstrictors may be applied to trigger points. Lidocaine injections into the muscles have been reported to contribute to pain control by reducing muscle activity and pain mediators.
The present study aims to evaluate the effects of occlusal splint therapy and lidocaine injection on the masseter, trapezius, and sternocleidomastoid muscles in patients diagnosed with myofascial pain, by analyzing internal echogenicity measurements obtained from archived ultrasonographic images.
Detailed description
Patients presenting to our clinic with pain and tenderness in the perimandibular and temporomandibular regions during rest and/or function will undergo a temporomandibular joint examination, together with palpation of the trapezius and sternocleidomastoid (SCM) muscles.
A total of 40 patients will be randomly allocated into two groups. Twenty patients will receive occlusal splint therapy, and twenty patients will receive lidocaine injection therapy.
Ultrasonographic images of the masseter, trapezius, and sternocleidomastoid muscles will be obtained before treatment and at the 3-month follow-up in both treatment groups.
In addition, 20 healthy individuals without any symptoms and with normal temporomandibular joint examination findings will be included as the control group.
These ultrasonographic images will be used to evaluate the internal echogenicity of the examined muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Occlusal Splint Group | Active comparator | Device: occlusal splintocclusal splint was made for this patients. |
| masseter muscle injection group | Active comparator | Drug: Lidocaine Hydrochloride 2% Injection SolutionIPatients in this group received intramuscular lidocaine injections into the masseter muscle trigger points. A total of 0.3 mL of Lidocaine Hydrochloride (20 mg/mL, Jetokain Simplex, ADEKA, Samsun, Türkiye) was injected into each trigger point. |
| Control group | No intervention | –Forty healthy volunteers were included as the control group and did not receive any treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No medical or surgical treatment for temporomandibular disorders within the last 3 months; Diagnosis of myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic decision tree; Presence of at least three trigger points (active or latent) in the masseter muscles on palpation; No missing teeth other than third molars; No history of occlusal splint therapy; No previous masticatory muscle injections or dry needling.
Key exclusion criteria (1 listed)
- Intra-articular disorders or degenerative joint disease according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic decision tree; Known allergy to local anesthetics; Presence of malignancy or history of head and neck radiotherapy or chemotherapy within the last 2 years; Presence of a bleeding disorder; Pregnancy or lactation; Drug and/or alcohol abuse; Active orthodontic treatment.
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 |
|---|---|---|
| occlusal splintPatients in this group were treated with an occlusal splint. | Device | Occlusal Splint Group |
| Lidocaine Hydrochloride 2% Injection Solution0,3 mlLidocaine Hydrochloride was injected to all trigger points. | Drug | masseter muscle injection group |
Primary outcome
The change of the pain score
Time frame: Before treatment (Day 0) and at 3 months after treatment initiation
Severity of the pain evaluated by the visual analog scale (VAS), rated from 0 (no pain) to 10 (the worst pain)
Internal Structure of muscles
Time frame: Before the treatment (day 0), and 3rd months of the treatment
Internal muscle structure was classified based on the visibility and width of intramuscular echogenic bands corresponding to muscle fibers.
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 11 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occlusal splint and Lidocaine Hydrochloride 2% Injection Solution in people with Myofascial Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 11 Aug 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 Turkey (Türkiye). 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?
The change of the pain score (time frame: Before treatment (Day 0) and at 3 months after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.