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

Not Applicable

Recruiting

• Conditions: Bruxism; Kinesiophobia; Temporomandibular Joint Disorders; Pain Threshold

• Registration Number: NCT05594511
• Lead Sponsor: University of Salamanca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-25
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-26
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25
• Primary Completion: 2023-06-23
• Study Completion: 2023-06-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in craniofacial pain intensity	2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.	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).

Secondary Outcome Measures

Name	Time	Method
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.	The active leftward mandibular translation will be measured using a digital caliper
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.	The active opening of the mouth will be measured using a digital caliper
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.	The active rightward mandibular translation will be measured using a digital caliper
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.	The pressure threshold will be recorded using a digital algometer
Changes in kinesiophobia	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	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).
Changes in pressure pain threshold at myofascial trigger point of the both digastric muscles	2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.	The pressure threshold will be recorded using a digital algometer
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.	The pressure threshold will be recorded using a digital algometer

Trial Locations

Locations (1)

University of Salamanca; 🇪🇸 Salamanca, Spain