Temporomandibular DisorderNCT05091996
The Use of Manual Muscle Relaxation Techniques in the Treatment of Temporomandibular Joint Disorders
A study testing Post-isometric muscle relaxation technique and Myofascial release technique in people with Temporomandibular Disorder and Temporomandibular Joint Disorders, run by Jagiellonian University.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 40 years
- Conditions the study is for
- Temporomandibular Disorder, Temporomandibular Joint Disorders
- What is being tested?
- Post-isometric muscle relaxation technique and Myofascial release technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Application of Manual Techniques in Masticatory Muscles Relaxation as Adjunctive Therapy in the Treatment of Temporomandibular Joint Disorders
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).
- Being tested
- Post-isometric muscle relaxation technique, Myofascial release technique
- Keywords
- Temporomandibular disorder, Physiotherapy
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-isometric muscle relaxation techniqueProcedure or surgery
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.
Myofascial release techniqueProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Post-isometric muscle relaxation group | Experimental | The post-isometric relaxation techniques were administered to the mandibular adductors and muscles responsible for lateral movements of the mandible. Receives: Procedure: Post-isometric muscle relaxation technique |
| Myofascial release group | Experimental | 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. Receives: Procedure: Myofascial release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study startJun 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartosz Trybulec, Jagiellonian University
- Investigators
- Bartosz Trybulec, PhD, Study chair, Jagiellonian University Medical College in Cracow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091996
- Sponsor's protocol ID
- 122.6120.129.2016
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Manual Techniques in Masticatory Muscles Relaxation as Adjunctive Therapy in the Treatment of Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT05091996
- Acronym / sponsor ID
- 122.6120.129.2016
- Keywords
- Temporomandibular disorder, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-isometric muscle relaxation group | Experimental | Procedure: Post-isometric muscle relaxation techniqueThe post-isometric relaxation techniques were administered to the mandibular adductors and muscles responsible for lateral movements of the mandible. |
| Myofascial release group | Experimental | Procedure: Myofascial release techniqueThe 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. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-isometric muscle relaxation technique1: 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. | Procedure or surgery | Post-isometric muscle relaxation group |
| Myofascial release techniqueThe 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 | Procedure or surgery | Myofascial release group |
Primary outcome
Change From Baseline Electrical Activity of the Anterior Part of the Temporal and Masseter Muscles at 10, and 14 days
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bartosz Trybulec, PhD study chair
Jagiellonian University Medical College in Cracow
Questions about this trial
What is this clinical trial studying?
A study testing Post-isometric muscle relaxation technique and Myofascial release technique in people with Temporomandibular Disorder and Temporomandibular Joint Disorders, run by Jagiellonian University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Electrical Activity of the Anterior Part of the Temporal and Masseter Muscles at 10, and 14 days (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.