Back to resultsMandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism
Primary Purpose
Temporomandibular Joint Disorders, Bruxism, Pain Threshold
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Muscle-energy mandibular technique
Sham technique
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders
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.
Sites / Locations
- University of SalamancaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental Group (muscle-energy technique)
Control Group (sham technique)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Changes in mouth opening mobility
The active opening of the mouth will be measured using a digital caliper
Changes in rightward mandibular translation
The active rightward mandibular translation will be measured using a digital caliper
Changes in leftward mandibular translation
The active leftward mandibular translation will be measured using a digital caliper
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
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
Changes in pressure pain threshold at myofascial trigger point of the both digastric muscles
The pressure threshold will be recorded using a digital algometer
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).
Full Information
NCT ID
NCT05594511
First Posted
October 20, 2022
Last Updated
May 23, 2023
Sponsor
University of Salamanca
Collaborators
Instituto de Investigación Biomédica de Salamanca
1. Study Identification
Unique Protocol Identification Number
NCT05594511
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
June 23, 2023 (Anticipated)
Study Completion Date
June 23, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
Collaborators
Instituto de Investigación Biomédica de Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Bruxism, Pain Threshold, Kinesiophobia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, controlled, prospective, double-blind, clinical trial
Masking
ParticipantOutcomes Assessor
Masking Description
The participants will be blinded because in both groups they were following the treatment and medical recommendations and they will also be attended by a physiotherapist, in one case the mandibular muscular energy technique will be performed and in the other the placebo technique.
The evaluators did not know to which group the participants belonged.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group (muscle-energy technique)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (sham technique)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Muscle-energy mandibular technique
Intervention Description
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
Intervention Name(s)
Sham technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in craniofacial pain intensity
Description
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).
Time Frame
2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Secondary Outcome Measure Information:
Title
Changes in mouth opening mobility
Description
The active opening of the mouth will be measured using a digital caliper
Time Frame
2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Title
Changes in rightward mandibular translation
Description
The active rightward mandibular translation will be measured using a digital caliper
Time Frame
2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Title
Changes in leftward mandibular translation
Description
The active leftward mandibular translation will be measured using a digital caliper
Time Frame
2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Title
Changes in Pressure pain threshold at myofascial trigger point (PT1) of the both upper trapezius muscles
Description
The pressure threshold will be recorded using a digital algometer
Time Frame
2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Title
Changes in pressure pain threshold at myofascial trigger point of the both external pterygoid muscles
Description
The pressure threshold will be recorded using a digital algometer
Time Frame
2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Title
Changes in pressure pain threshold at myofascial trigger point of the both digastric muscles
Description
The pressure threshold will be recorded using a digital algometer
Time Frame
2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group.
Title
Changes in kinesiophobia
Description
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).
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Méndez-Sánchez, PhD
Phone
+34 923294500
Ext
3201
Email
ro_mendez@usal.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Méndez-Sánchez, PhD
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Márquez-Vera, PT
Organizational Affiliation
Institute for Biomedical Research of Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Méndez-Sánchez, PhD
Phone
+34 923294400
Ext
3201
Email
ro_mendez@usal.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism
We'll reach out to this number within 24 hrs