Temporomandibular Joint DisordersNCT05594511
Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism
A study testing Muscle-energy mandibular technique in people with Temporomandibular Joint Disorders and Bruxism, run by University of Salamanca at 1 site in Spain.
Trial summary
This is a randomized, controlled, double-blind clinical trial. The main objective is to evaluate the immediate effect of the mandibular muscle-energy technique on pain, functionality and kinesiophobia in subjects suffering from temporomandibular dysfunction and bruxism. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Bruxism, Pain Threshold
- What is being tested?
- Muscle-energy mandibular technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 25 Apr 2022to 23 Jun 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who agree to participate in the study by signing the informed consent form.
- Patients attending maxillofacial consultation with pain, temporomandibular dysfunction and bruxism.
- Pain of at least 3 months of evolution.
Who cannot join
- Patients with congenital malformations or cervical spine pathology.
- Infectious or inflammatory disease in its acute phase.
- Patients with vertigo or vestibular alterations.
- If there is a contraindication to the technique or phobia on the part of the patient.
- Physiotherapy treatment (manual therapy or electrotherapy) in the last month before their incorporation in the study.
- Pharmacological treatment (analgesics, relaxants and anti-inflammatory drugs) in the last 24 hours before the initial evaluation.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Salamanca
Salamanca, 37007
Roberto Méndez-Sánchez, PhD, +34 923294400 ext. 3201, ro_mendez@usal.es
About this study
Official title: Immediate Effects of the Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism. Randomized Controlled Clinical Trial
This is a randomized, controlled, double-blind clinical trial. The main objective is to evaluate the immediate effect of the mandibular muscle-energy technique on pain, functionality and kinesiophobia in subjects suffering from temporomandibular dysfunction and bruxism.
In the experimental group the jaw muscle-energy technique will be applied and in the control group a placebo technique will be applied. The intention is to see the immediate effects of the intervention and two evaluations of the pre- and post-intervention outcome variables and a follow-up of kinesiophobia one week later will be performed.
- Being tested
- Muscle-energy mandibular technique, Sham technique
- Medical subject headings
- Temporomandibular Joint Disorders, Bruxism, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle-energy mandibular techniqueProcedure or surgery
A single session will be used with the mandibular musculoenergy technique. It will last approximately 2-3 minutes and will be performed by a physiotherapist.
Sham techniqueProcedure or surgery
A single session with a sham technique simulating the suboccipital muscle inhibition technique will be used. It will last approximately 2-3 minutes and will be performed by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (muscle-energy technique) | Experimental | Mandibular muscle energy technique: In the supine position, the patient will open the mouth and perform isometric contractions for closure controlled by the physiotherapist. Passively, the physiotherapist will increase the range of mandibular opening. The technique consists of performing 3 sets, with 3 isometric contractions in each set of 3 seconds each. At the end of each set, the physiotherapist will passively try to gain mouth opening in order to continue the rest of the sets. At the end of all sets, gently return to the resting position. Receives: Procedure: Muscle-energy mandibular technique |
| Control Group (sham technique) | Sham comparator | Sham technique: In the supine position, the physiotherapist will place his hands under the patient's skull with the fingertips in contact with the suboccipital musculature for 5 minutes, without applying pressure or therapeutic intent. The objective is to provide a stimulus as similar as possible to the original Suboccipital Inhibition Technique, but without force of movement. The patient will keep the eyes closed for the duration of the technique. Receives: Procedure: Sham technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in craniofacial pain intensity
For the subjective evaluation of craniofacial pain, the visual analog scale (VAS) will be applied. Scale from 0 (no pain at all) to 10 (maximum possible pain).
Measured: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Secondary outcomes (7)
Changes in mouth opening mobility
The active opening of the mouth will be measured using a digital caliper
Measured: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in rightward mandibular translation
The active rightward mandibular translation will be measured using a digital caliper
Measured: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in leftward mandibular translation
The active leftward mandibular translation will be measured using a digital caliper
Measured: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in Pressure pain threshold at myofascial trigger point (PT1) of the both upper trapezius muscles
The pressure threshold will be recorded using a digital algometer
Measured: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in pressure pain threshold at myofascial trigger point of the both external pterygoid muscles
The pressure threshold will be recorded using a digital algometer
Measured: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in pressure pain threshold at myofascial trigger point of the both digastric muscles
The pressure threshold will be recorded using a digital algometer
Measured: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in kinesiophobia
The Kinesiophobia will be recorded using the spanish version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD-S). It is a valid and reliable instrument for measuring kinesiophobia in patients with TMD, and it uses a Likert scale (1-4) containing 11 items in 2 domains, with higher scores indicating higher levels of kinesiophobia (0-44).
Measured: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. And a follow-up after one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start25 Apr 2022
- Primary completion23 Jun 2023 (estimated)
- Study completion23 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, prospective, double-blind, clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Principal investigator, Roberto Méndez Sánchez, University of Salamanca
- Investigators
- Roberto Méndez-Sánchez, PhD, Principal investigator, University of SalamancaAntonio Márquez-Vera, PT, Principal investigator, Institute for Biomedical Research of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594511
- Sponsor's protocol ID
- 2019-11-386-USalamanca
- Status last verified
- May 2023
- First submitted
- 20 Oct 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of the Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism. Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05594511
- Acronym / sponsor ID
- 2019-11-386-USalamanca
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 23 Jun 2023 (estimated)
- Study completion
- 23 Jun 2023 (estimated)
- First posted
- 26 Oct 2022 (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.
This is a randomized, controlled, double-blind clinical trial. The main objective is to evaluate the immediate effect of the mandibular muscle-energy technique on pain, functionality and kinesiophobia in subjects suffering from temporomandibular dysfunction and bruxism.
In the experimental group the jaw muscle-energy technique will be applied and in the control group a placebo technique will be applied. The intention is to see the immediate effects of the intervention and two evaluations of the pre- and post-intervention outcome variables and a follow-up of kinesiophobia one week later will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, controlled, prospective, double-blind, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (muscle-energy technique) | Experimental | Procedure: Muscle-energy mandibular techniqueMandibular muscle energy technique: In the supine position, the patient will open the mouth and perform isometric contractions for closure controlled by the physiotherapist. Passively, the physiotherapist will increase the range of mandibular opening. The technique consists of performing 3 sets, with 3 isometric contractions in each set of 3 seconds each. At the end of each set, the physiotherapist will passively try to gain mouth opening in order to continue the rest of the sets. At the end of all sets, gently return to the resting position. |
| Control Group (sham technique) | Sham comparator | Procedure: Sham techniqueSham technique: In the supine position, the physiotherapist will place his hands under the patient's skull with the fingertips in contact with the suboccipital musculature for 5 minutes, without applying pressure or therapeutic intent. The objective is to provide a stimulus as similar as possible to the original Suboccipital Inhibition Technique, but without force of movement. The patient will keep the eyes closed for the duration of the technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who agree to participate in the study by signing the informed consent form.
- Patients attending maxillofacial consultation with pain, temporomandibular dysfunction and bruxism.
- Pain of at least 3 months of evolution.
Key exclusion criteria (6 listed)
- Patients with congenital malformations or cervical spine pathology.
- Infectious or inflammatory disease in its acute phase.
- Patients with vertigo or vestibular alterations.
- If there is a contraindication to the technique or phobia on the part of the patient.
- Physiotherapy treatment (manual therapy or electrotherapy) in the last month before their incorporation 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 |
|---|---|---|
| Muscle-energy mandibular techniqueA single session will be used with the mandibular musculoenergy technique. It will last approximately 2-3 minutes and will be performed by a physiotherapist. | Procedure or surgery | Experimental Group (muscle-energy technique) |
| Sham techniqueA single session with a sham technique simulating the suboccipital muscle inhibition technique will be used. It will last approximately 2-3 minutes and will be performed by a physiotherapist. | Procedure or surgery | Control Group (sham technique) |
Primary outcome
Changes in craniofacial pain intensity
Time frame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
For the subjective evaluation of craniofacial pain, the visual analog scale (VAS) will be applied. Scale from 0 (no pain at all) to 10 (maximum possible pain).
7 secondary outcomes
Changes in mouth opening mobility
Time frame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in rightward mandibular translation
Time frame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in leftward mandibular translation
Time frame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in Pressure pain threshold at myofascial trigger point (PT1) of the both upper trapezius muscles
Time frame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in pressure pain threshold at myofascial trigger point of the both external pterygoid muscles
Time frame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in pressure pain threshold at myofascial trigger point of the both digastric muscles
Time frame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Changes in kinesiophobia
Time frame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. And a follow-up after one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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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.
Roberto Méndez-Sánchez, PhD principal investigator
University of Salamanca
Antonio Márquez-Vera, PT principal investigator
Institute for Biomedical Research of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle-energy mandibular technique in people with Temporomandibular Joint Disorders and Bruxism, run by University of Salamanca at 1 site in Spain.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Méndez-Sánchez, PhD (+34 923294500 ext. 3201, ro_mendez@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in craniofacial pain intensity (time frame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.). 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 May 2023.