The Use of Manual Muscle Relaxation Techniques in the Treatment of Temporomandibular Joint Disorders
The Application of Manual Techniques in Masticatory Muscles Relaxation as Adjunctive Therapy in the Treatment of Temporomandibular Joint Disorders
1 other identifier
interventional
60
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 28, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedOctober 25, 2021
October 1, 2021
2.5 years
September 28, 2021
October 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 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
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.
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
Study Arms (2)
Post-isometric muscle relaxation group
EXPERIMENTALThe post-isometric relaxation techniques were administered to the mandibular adductors and muscles responsible for lateral movements of the mandible.
Myofascial release group
EXPERIMENTALThe 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bartosz Trybulec, PhD
Jagiellonian University Medical College in Cracow
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 28, 2021
First Posted
October 25, 2021
Study Start
June 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 25, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- starting from the time when summary data are published
- Access Criteria
- via e-mail on request
all IPD that underlie results in a publication