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Ultrasonographic Assessment of Muscle Echogenicity in Myofascial Pain (UAMEMP)

27 giugno 2026 aggiornato da: reyhan saglam-dogu, Istanbul Medipol University Hospital

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.

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Descrizione

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Occlusal Splint Group
occlusal splint was made for this patients.
Patients in this group were treated with an occlusal splint.
Comparatore attivo: masseter muscle injection group
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.
0,3 mlLidocaine Hydrochloride was injected to all trigger points.
Nessun intervento: Control group
Forty healthy volunteers were included as the control group and did not receive any treatment.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The change of the pain score
Lasso di tempo: 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)
Before treatment (Day 0) and at 3 months after treatment initiation
Internal Structure of muscles
Lasso di tempo: 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.
Before the treatment (day 0), and 3rd months of the treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 maggio 2026

Completamento primario (Stimato)

30 luglio 2026

Completamento dello studio (Stimato)

30 agosto 2026

Date di iscrizione allo studio

Primo inviato

23 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dolore miofasciale

Prove cliniche su occlusal splint

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