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The Use of Manual Muscle Relaxation Techniques in the Treatment of Temporomandibular Joint Disorders

Primary Purpose

Temporomandibular Disorder, Temporomandibular Joint Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Post-isometric muscle relaxation technique
Myofascial release technique
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Temporomandibular Disorder focused on measuring Temporomandibular disorder, Physiotherapy

Eligibility Criteria

19 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed functional disorders of the masticatory system with the accompanying excessive tension of the masseter muscles,
  • no clinical signs of displacement of the disc with a blockage in the temporomandibular joint,
  • spontaneous pain in the masticatory muscles, lasting at least one month before treatment,
  • good general health of the patient,
  • full dental arches
  • written consent to participate in the study

Exclusion Criteria:

  • occurrence of a face or head injury during participation in the research project,
  • open wounds in the area where the therapy was carried out,
  • sudden illness of the patient preventing participation in the study,
  • the will to terminate participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Post-isometric muscle relaxation group

    Myofascial release group

    Arm Description

    The post-isometric relaxation techniques were administered to the mandibular adductors and muscles responsible for lateral movements of the mandible.

    The myofascial release procedure was performed successively in the area of the anterior parts of the temporal muscles, the superficial parts of the masseter muscles and the sternocleidomastoid muscles.

    Outcomes

    Primary Outcome Measures

    Change From Baseline Electrical Activity of the Anterior Part of the Temporal and Masseter Muscles at 10, and 14 days
    The electrical activity of the anterior part of the temporal and masseter muscles was assessed by surface electromyography (sEMG). The assessment was performed using a two-channel device - NeuroTrac MyoPlus 4 (Verity Medical Ltd.) and surface electrodes (Noraxon inc.). Examination of the same muscles on the right and left sides of the body was performed at the same time. The muscle tone of the anterior part of the temporal muscles was assessed first, followed by the masseter muscles. The parameter describing the degree of electrical activity of the muscle was the mean value of the thirty-second sEMG measurement.
    Change From Baseline in Muscle Pain Scores on the Visual Analog Scale at 10, and 14 days
    Assessment of the intensity of spontaneous pain in the masticatory muscles The intensity of spontaneous pain in the masticatory muscles was assessed on the basis of a 10-point visual analogue scale(VAS).This scale included 11 pain grades- from 0 to 10,where 0 was no pain at all, 5 was moderate pain, and 10 was the strongest pain imaginable.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 28, 2021
    Last Updated
    October 11, 2021
    Sponsor
    Jagiellonian University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05091996
    Brief Title
    The Use of Manual Muscle Relaxation Techniques in the Treatment of Temporomandibular Joint Disorders
    Official Title
    The Application of Manual Techniques in Masticatory Muscles Relaxation as Adjunctive Therapy in the Treatment of Temporomandibular Joint Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    December 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Jagiellonian University

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of the study was to compare the degree of relaxation of the anterior part of the temporal muscles and the masseter muscles achieved with the use of post-isometric relaxation and myofascial release methods in patients requiring prosthetic treatment due to temporomandibular joint disorders (TMD) with a dominant muscular component. The study included 60 patients, both sexes, aged between 19 and 40. The patients who met the inclusion criteria were alternately assigned to one of the two study groups: I group consisted of the patients received post-isometric relaxation treatment (PIR), II group - patients received myofascial release treatment (MFR). Each group consisted of 30 subjects. The series of ten treatments were performed in both groups. The comparative assessment was carried out based on the data obtained from the physical examination, physiotherapeutic examination of the masticatory system, surface electromyography (sEMG) of anterior temporal and masseter muscles and the data on the intensity of spontaneous masticatory muscle pain assessed using the Visual Analogue Scale (VAS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Disorder, Temporomandibular Joint Disorders
    Keywords
    Temporomandibular disorder, Physiotherapy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Post-isometric muscle relaxation group
    Arm Type
    Experimental
    Arm Description
    The post-isometric relaxation techniques were administered to the mandibular adductors and muscles responsible for lateral movements of the mandible.
    Arm Title
    Myofascial release group
    Arm Type
    Experimental
    Arm Description
    The myofascial release procedure was performed successively in the area of the anterior parts of the temporal muscles, the superficial parts of the masseter muscles and the sternocleidomastoid muscles.
    Intervention Type
    Procedure
    Intervention Name(s)
    Post-isometric muscle relaxation technique
    Intervention Description
    1: Therapist (T) abducted the patients' (P) mandible until the functional barrier. P performed isometric tension of the mandibular adductors with about 20% of the maximum force, balanced by the T. After 10 secs of isometric tension, P relaxed his muscles, and T abducted the mandible to a new functional barrier. During one treatment, the cycle was repeated 3 times, each time starting from the previously obtained barrier. 2: T performed passive lateral translation of the mandible until the functional barrier. P performed isometric tension with about 20% of maximum force, as to initiate the movement of the mandible towards the resting position. T balanced the force generated by the P. After 10 secs of isometric tension, P relaxed his muscles and T deepened the lateral movement of the mandible until a new functional barrier was reached. During one treatment, the cycle was repeated 3 times, both to the right and left side, each time starting from the previously obtained barrier.
    Intervention Type
    Procedure
    Intervention Name(s)
    Myofascial release technique
    Intervention Description
    The myofascial release procedure was performed successively in the area of: the anterior parts of the temporal muscles , the superficial parts of the masseter muscles and the sternocleidomastoid muscles.During one session, the above cycle was repeated six times on both sides separately. The was lying on his back, with his head turned to the side.The therapist was behind the patient's head, using the pad of the first finger placed on the skin in the area of the initial attachment of a worked muscle, he took out the tissue slack, moving the tissues towards the perceptible limitation of mobility (caudal direction).Reaching the tissue barrier, he kept the tension of the sliding structures, shifting them until the physiological tissue barrier.A single application of the myofascial release procedure consisted of one movement moving the soft tissues along the muscle
    Primary Outcome Measure Information:
    Title
    Change From Baseline Electrical Activity of the Anterior Part of the Temporal and Masseter Muscles at 10, and 14 days
    Description
    The electrical activity of the anterior part of the temporal and masseter muscles was assessed by surface electromyography (sEMG). The assessment was performed using a two-channel device - NeuroTrac MyoPlus 4 (Verity Medical Ltd.) and surface electrodes (Noraxon inc.). Examination of the same muscles on the right and left sides of the body was performed at the same time. The muscle tone of the anterior part of the temporal muscles was assessed first, followed by the masseter muscles. The parameter describing the degree of electrical activity of the muscle was the mean value of the thirty-second sEMG measurement.
    Time Frame
    Change From Baseline Electrical Activity of the Muscles at 10, and 14 days; Triple measurement: immediately before supportive treatment, after the last of the 10 relaxation treatments and on the 4th day after the end of therapy
    Title
    Change From Baseline in Muscle Pain Scores on the Visual Analog Scale at 10, and 14 days
    Description
    Assessment of the intensity of spontaneous pain in the masticatory muscles The intensity of spontaneous pain in the masticatory muscles was assessed on the basis of a 10-point visual analogue scale(VAS).This scale included 11 pain grades- from 0 to 10,where 0 was no pain at all, 5 was moderate pain, and 10 was the strongest pain imaginable.
    Time Frame
    Change From Baseline in Muscle Pain Scores on the Visual Analog Scale at 10, and 14 days; Triple measurement: immediately before supportive treatment, after the last of the 10 relaxation treatments and on the 4th day after the end of therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosed functional disorders of the masticatory system with the accompanying excessive tension of the masseter muscles, no clinical signs of displacement of the disc with a blockage in the temporomandibular joint, spontaneous pain in the masticatory muscles, lasting at least one month before treatment, good general health of the patient, full dental arches written consent to participate in the study Exclusion Criteria: occurrence of a face or head injury during participation in the research project, open wounds in the area where the therapy was carried out, sudden illness of the patient preventing participation in the study, the will to terminate participation in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bartosz Trybulec, PhD
    Organizational Affiliation
    Jagiellonian University Medical College in Cracow
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    all IPD that underlie results in a publication
    IPD Sharing Time Frame
    starting from the time when summary data are published
    IPD Sharing Access Criteria
    via e-mail on request

    Learn more about this trial

    The Use of Manual Muscle Relaxation Techniques in the Treatment of Temporomandibular Joint Disorders

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