- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07676799
Ultrasonographic Assessment of Muscle Echogenicity in Myofascial Pain (UAMEMP)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Istanbul, Turecko (Türkiye)
- Istanbul Medipol University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Occlusal Splint Group
occlusal splint was made for this patients.
|
Patients in this group were treated with an occlusal splint.
|
|
Aktivní komparátor: 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.
|
|
Žádný zásah: Control group
Forty healthy volunteers were included as the control group and did not receive any treatment.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The change of the pain score
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 749
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Myofasciální bolest
-
Quiropraxia y EquilibrioUniversidad Nacional Andres BelloDokončenoMyofascial Trigger Point Pain (MTrP)Chile
-
Quiropraxia y EquilibrioNáborMyofascial Trigger Point Pain (MTrP)Chile
-
Ankara UniversityDokončenoMyofascial Trigger Point Pain (MTrP) | Ultrazvukové zkoušky | Axiální spondylartritida (axSpA)Krocan
-
Liu JiuhongDokončenoRebound Pain | Lipozomální bupivakainČína
-
University of VirginiaZatím nenabírámeArtroplastika ramene | Interscalene Block | Rebound PainSpojené státy
-
Karaman Training and Research HospitalDokončeno
-
Ajou University School of MedicineNábor
-
Beijing Sport UniversityZatím nenabírámePatellofemoral Pain, PFP
-
Beijing Sport UniversityZatím nenabíráme
-
Istanbul University - CerrahpasaNáborPatellofemoral Pain, PFPTurecko (Türkiye)
Klinické studie na occlusal splint
-
Johns Hopkins UniversityZatím nenabírámeMalokluze, úhlová třída II | Malokluze, úhlová třída III | Malokluze, úhlová třída I
-
St. Paul's Hospital, CanadaDokončeno
-
Hanyang UniversityNeznámý
-
The General Authority for Teaching Hospitals and...NáborŘízení | Denis Brawn Brace | Úprava | Idiopatický klub | Ponseti castingEgypt
-
National University Hospital, SingaporeNábor
-
University Hospital Inselspital, BerneNábor
-
Brooke Army Medical CenterNeznámý
-
Washington University School of MedicineDokončenoZlomeniny distální radiální sponySpojené státy
-
The Philadelphia & South Jersey Hand CenterNeznámýPrst na spoušti | Stenózní tenosynovitidaSpojené státy
-
Brigham and Women's HospitalDokončenoPooperační techniky šetřící časSpojené státy