Shear Wave Sonoelastography in the Diagnosis and Management of the Masseter Muscles Disorders

NCT03844854 | Unknown

• 1 other identifier: PREL.B160.18.007.
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Contemporary medicine lacks sensitive and objective diagnostic methods for the evaluation of patients with temporomandibular disorders (TMD). Shear wave sonoelastography allows for objective assessment of hardness, tone, and cohesiveness of tissues. Results are expressed in kilopascals (kPa) and can be compared at different time points in the same patient or between patients. The method is non-invasive and safe without any unpleasant experiences for patients. The project aims to evaluate the usefulness of shear wave sonoelastography in the diagnosis and monitoring of the management of masseter muscles disorders in TMD. The project will analyze shear wave sonoelastography to determine the pathological tone of masticatory muscles in TMD characterized by pain, abnormal jaw movements and frequent coexistence of headache, otolaryngological disorders, as well as increased tension and pain in the muscles of the neck and shoulder girdle. In the first stage, standardization of sonoelastography of masseter muscles on healthy subjects without TMD will be performed. Normal values of elasticity for various groups of patients as well as factors affecting the result of the study will be determined. Standardization will cover the methodology of the examination. The second stage will assess efficacy of this method in monitoring the treatment progress in patients with TMD diagnosed with the DC-TMD protocol. Standardized sonoelastography examinations and assessment of pain and oral health will be conducted in healthy subjects and in TMD patients at baseline and after 12 weeks of treatment with manual therapy and stabilization occlusal splint. As a result, it will be possible to compare sonoelastography changes in muscle structure in relation to regression of clinical symptoms in response to treatment and to compare sonoelastography results to currently used methods for assessment of TMD. The need for reliable determining of the sonoelastography values for diagnosis of TMD exist. The hardness of muscles of the human body vary, but norms for masticatory muscles remain undetermined. Available reports are inconclusive. They do not provide a methodology and do not address factors such as age, sex, examination at rest and during jaw-clenching. The present project eliminates those limitations, and as a result, contemporary medicine will get the basis for introducing sonoelastography for the diagnosis and monitoring of masticatory muscles disorders in various groups of patients.

Conditions

Temporomandibular Disorders

Keywords

Sonoelastography; Elastography; Shear-wave; Masseter muscle; Temporomandibular disorders

Outcome Measures

Primary Outcomes (2)

• Determination of normal elasticity values of the masseter muscle

  Elasticity values of the masseter muscle will be measured using shear wave elastography in patients without temporomandibular disorders.

  12 months

• Comparison of elasticity values of the masseter muscle between study groups.

  Elasticity values of the masseter muscle will be measured using shear wave elastography in patients with temporomandibular disorders.

  12 months

Secondary Outcomes (3)

• Comparison of the mean intensity of pain between study groups.

  12 months

• Comparison of oral health status between study groups.

  12 months

• Number of participants with treatment-related adverse events

  12 months

Study Arms (2)

Control Group

NO INTERVENTION

Without intervention.

Research Group

EXPERIMENTAL

With providing stabilization occlusal splint and manual therapy.

Other: Stabilization occlusal splint and manual therapy

Interventions

Stabilization occlusal splint and manual therapy OTHER

Providing stabilization occlusal splint and manual therapy

Research Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• First stage with include people without the history of temporomandibular disorders and without any deviations from normal values according to DC-TMD protocol
• Second stage: Patients with TMD without previous history of treatment
• Age between 18 and 60

You may not qualify if:

• Patients treated with drugs affecting muscle function
• Not agreeing to participate in the study
• Age under 18
• Age over 60
• Terminal general diseases
• Severe mental disorders
• Neoplasm disease
• Neuromuscular disorders
• Severe hormonal disorders

Sponsors & Collaborators

• Wroclaw Medical University: lead
• National Science Centre, Poland: collaborator

Related Publications (1)

• Olchowy A, Seweryn P, Olchowy C, Wieckiewicz M. Assessment of the masseter stiffness in patients during conservative therapy for masticatory muscle disorders with shear wave elastography. BMC Musculoskelet Disord. 2022 May 11;23(1):439. doi: 10.1186/s12891-022-05392-9.

  PMID: 35546396 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mieszko Wieckiewicz, DMD MSc PhD

  Department of Experimental Dentistry, Wroclaw Medical University, Poland

  STUDY DIRECTOR

Central Study Contacts

Anna Olchowy, DMD

CONTACT

+48663953879; ania.olchowy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The aim of the first stage is a development of the sonoelastography methodology with precise determination of the positioning of the sonography head and the patient's condyle in temporomandibular joints as well as a determination of the normal range of masticatory muscle structure in the population of healthy subjects. This stage includes people without a history of temporomandibular disorders. The second stage is devoted to the assessment of the sonoelastography in the monitoring of the efficacy of treatment. The study group will undergo treatment of masticatory muscles disorders using manual therapy and stabilization occlusal splint. The assessment of severity of pain with Numerical Rating Scale (NRS) and quality of life associated with oral health using standardized international questionnaire will be conducted at baseline and after 12 weeks of treatment.

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: February 19, 2019
• Study Start: April 20, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2021
• Last Updated: April 4, 2019

Record last verified: 2019-04