Ultrasonographic Assessment of Muscle Echogenicity in Myofascial Pain

NCT07676799 | Active Not Recruiting

• 1 other identifier: 749
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Myofascial Pain

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Before the treatment (day 0), and 3rd months of the treatment

Study Arms (3)

Occlusal Splint Group

ACTIVE COMPARATOR

occlusal splint was made for this patients.

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.

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.

Interventions

occlusal splint DEVICE

Patients in this group were treated with an occlusal splint.

Occlusal Splint Group

Lidocaine Hydrochloride 2% Injection Solution DRUG

0,3 mlLidocaine Hydrochloride was injected to all trigger points.

masseter muscle injection group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Occlusal Splints; Lidocaine

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator performing the ultrasonographic examinations and the investigator responsible for data analysis were blinded to the group allocation of the participants. The patients' treatment assignments were not disclosed to these assessors throughout the study period.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Oral and Maxillofacial Surgery, Principal Investigator

Model Details: A prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: May 16, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)