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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bruxism; Temporomandibular Joint Disorders; Kinesiophobia; Pain Threshold
• Intervention / Treatment: Procedure: Muscle-energy mandibular technique; Procedure: Sham technique

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Méndez-Sánchez, PhD; Phone Number: 3201 +34 923294500; Email: ro_mendez@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Recruiting
    • University of Salamanca
    • Contact: Roberto Méndez-Sánchez, PhD; Phone Number: 3201 +34 923294400; Email: ro_mendez@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Salamanca
• Collaborators: Instituto de Investigación Biomédica de Salamanca
• Investigators: Principal Investigator: Antonio Márquez-Vera, PT, Institute for Biomedical Research of Salamanca; Principal Investigator: Roberto Méndez-Sánchez, PhD, University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Estimated): June 23, 2023
• Study Completion (Estimated): June 23, 2023

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Anxiety Disorders; Tooth Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Phobic Disorders; Myofascial Pain Syndromes; Joint Diseases; Bruxism; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Kinesiophobia
• Other Study ID Numbers: 2019-11-386-USalamanca

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No