Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism

Study Overview
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Brief Summary
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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.

Official Title
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Immediate Effects of the Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism. Randomized Controlled Clinical Trial

Conditions
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Temporomandibular Joint Disorders, Bruxism, Pain Threshold, Kinesiophobia

Intervention / Treatment
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* Procedure: Muscle-energy mandibular technique
* Procedure: Sham technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, controlled, prospective, double-blind, clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group (muscle-energy technique)<br>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<br>* 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.<br>|
| Sham Comparator: Control Group (sham technique)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mouth opening mobility | The active opening of the mouth will be measured using a digital caliper | 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 | 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 | 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 | 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 | 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 | 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). | 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 |