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

Sponsor
University of Salamanca (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05594511
Collaborator
Instituto de Investigación Biomédica de Salamanca (Other)
60
1
2
3.9
15.5

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Muscle-energy mandibular technique
  • Procedure: Sham technique
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized, controlled, prospective, double-blind, clinical trialrandomized, controlled, prospective, double-blind, clinical trial
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The participants will be blinded because in both groups they were following the treatment and medical recommendations and they will also be attended by a physiotherapist, in one case the mandibular muscular energy technique will be performed and in the other the placebo technique. The evaluators did not know to which group the participants belonged.
Primary Purpose:
Treatment
Official Title:
Immediate Effects of the Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism. Randomized Controlled Clinical Trial
Anticipated Study Start Date :
Oct 25, 2022
Anticipated Primary Completion Date :
Dec 23, 2022
Anticipated Study Completion Date :
Feb 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group (muscle-energy technique)

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
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 Comparator: Control Group (sham 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 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.

Outcome Measures

Primary Outcome Measures

  1. Changes in craniofacial pain intensity [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).

Secondary Outcome Measures

  1. Changes in mouth opening mobility [2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.]

    The active opening of the mouth will be measured using a digital caliper

  2. Changes in rightward mandibular translation [2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.]

    The active rightward mandibular translation will be measured using a digital caliper

  3. Changes in leftward mandibular translation [2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.]

    The active leftward mandibular translation will be measured using a digital caliper

  4. Changes in Pressure pain threshold at myofascial trigger point (PT1) of the both upper trapezius muscles [2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.]

    The pressure threshold will be recorded using a digital algometer

  5. Changes in pressure pain threshold at myofascial trigger point of the both external pterygoid muscles [2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.]

    The pressure threshold will be recorded using a digital algometer

  6. Changes in pressure pain threshold at myofascial trigger point of the both digastric muscles [2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.]

    The pressure threshold will be recorded using a digital algometer

  7. Changes in kinesiophobia [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]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Salamanca Salamanca Spain 37007

Sponsors and Collaborators

  • University of Salamanca
  • Instituto de Investigación Biomédica de Salamanca

Investigators

  • Principal Investigator: Roberto Méndez-Sánchez, PhD, University of Salamanca
  • Principal Investigator: Antonio Márquez-Vera, PT, Institute for Biomedical Research of Salamanca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roberto Méndez Sánchez, Professor, PhD, University of Salamanca
ClinicalTrials.gov Identifier:
NCT05594511
Other Study ID Numbers:
  • 2019-11-386-USalamanca
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022