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

NCT ID: NCT05594511

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2023-06-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Muscle-energy mandibular technique

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sham technique

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role: collaborator

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Roberto Méndez Sánchez

Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Méndez-Sánchez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Antonio Márquez-Vera, PT

Role: PRINCIPAL_INVESTIGATOR

Institute for Biomedical Research of Salamanca

Locations

University of Salamanca

Salamanca, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Roberto Méndez-Sánchez, PhD

Role: CONTACT

ro_mendez@usal.es

+34 923294500 ext. 3201

Facility Contacts

Roberto Méndez-Sánchez, PhD

Role: primary

ro_mendez@usal.es

+34 923294400 ext. 3201

Other Identifiers

2019-11-386-USalamanca

Identifier Type: -

Identifier Source: org_study_id