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
About this trial
This is an interventional supportive care trial for Temporomandibular Disorder focused on measuring Temporomandibular disorder, Physiotherapy
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
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
NCT ID
NCT05091996
First Posted
September 28, 2021
Last Updated
October 11, 2021
Sponsor
Jagiellonian University
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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