Clinical trial NCT05594511: Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism
Official title: Immediate Effects of the Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism. Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Joint Disorders
Bruxism
Pain Threshold
Kinesiophobia
Lead sponsor: University of Salamanca
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
First posted: 2022-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled, prospective, double-blind, clinical trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in craniofacial pain intensity
timeFrame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Secondary outcomes:
measure: Changes in mouth opening mobility
timeFrame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
measure: Changes in rightward mandibular translation
timeFrame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
measure: Changes in leftward mandibular translation
timeFrame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
measure: Changes in Pressure pain threshold at myofascial trigger point (PT1) of the both upper trapezius muscles
timeFrame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
measure: Changes in pressure pain threshold at myofascial trigger point of the both external pterygoid muscles
timeFrame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
measure: Changes in pressure pain threshold at myofascial trigger point of the both digastric muscles
timeFrame: 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
measure: Changes in kinesiophobia
timeFrame: 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
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: University of Salamanca
Study officials:
affiliation: University of Salamanca
name: Roberto Méndez-Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Biomedical Research of Salamanca
name: Antonio Márquez-Vera, PT
role: PRINCIPAL_INVESTIGATOR
References: