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

NCT05594511 | Unknown

• 1 other identifier: 2019-11-386-USalamanca
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders; Bruxism; Pain Threshold; Kinesiophobia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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.

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.

Procedure: Sham technique

Interventions

Muscle-energy mandibular technique PROCEDURE

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.

Experimental Group (muscle-energy technique)

Sham technique PROCEDURE

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.

Control Group (sham technique)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator

Study Sites (1)

University of Salamanca

Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Bruxism; Kinesiophobia

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases; Habits; Behavior; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Roberto Méndez-Sánchez, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Antonio Márquez-Vera, PT

  Institute for Biomedical Research of Salamanca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Méndez-Sánchez, PhD

CONTACT

+34 923294500; ro_mendez@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: randomized, controlled, prospective, double-blind, clinical trial

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 26, 2022
• Study Start: April 25, 2022
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)