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

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05594511
• Other study ID #: 2019-11-386-USalamanca
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: June 23, 2023

Study information

• Verified date: May 2023
• Source: University of Salamanca
• Contact: Roberto Méndez-Sánchez, PhD
• Phone: +34 923294500
• Email: ro_mendez[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bruxism
• Joint Diseases
• Kinesiophobia
• Pain Threshold
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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 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.

Locations

Country	Name	City	State
Spain	University of Salamanca	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
University of Salamanca	Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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