An interventional study of Muscle-energy mandibular technique and Sham technique in Temporomandibular Joint Disorders, Bruxism and Pain Threshold, sponsored by University of Salamanca. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by University of Salamanca · Not applicable, Interventional, and Treatment
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.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →University of Salamanca is the lead sponsor of 112 studies on the registry; 47 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Muscle-energy mandibular technique
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.
Procedure: Sham technique
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.
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.
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).
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 mouth opening mobility
The active opening of the mouth will be measured using a digital caliper
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
The active rightward mandibular translation will be measured using a digital caliper
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
The active leftward mandibular translation will be measured using a digital caliper
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
The pressure threshold will be recorded using a digital algometer
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
The pressure threshold will be recorded using a digital algometer
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
The pressure threshold will be recorded using a digital algometer
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
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).
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
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Jun 2023, 13 months after the start.
Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 13 months is above that.
Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.
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