Effects of Electric Massage on the Cervical Region in Subjects Diagnosed With Temporomandibular Disorders

Temporomandibular Disorders Clinical Trial

Official title:

Effects of Electric Massage on the Cervical Region Combined With Local Techniques on the Temporomandibular Joint Versus an Intervention Only With Local Techniques in Subjects Diagnosed With Temporomandibular Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098952
• Other study ID #: LE0001
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: October 14, 2021

Study information

• Verified date: November 2021
• Source: Universidad de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To know the short-term effects of electric massage applied on the cervical region combined with local techniques on the temporomandibular joint versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders.

Description:

This study aims to know the short-term effects of electric massage applied to the cervical region combined with local techniques on the temporomandibular pain versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders. This is a prospective, controlled, single-blind clinical trial of 46 subjects randomly divided into two groups: Group 1 Manual Therapy=21; Group 2 Interferential massage plus Manual Therapy=25. Group 1 will receive manual therapy consisting of techniques of ischemic compression on masseter muscles and soft-tissue release technique over the temporal región. Group 2, in addition to the intervention in group 1, will receive electric massage with interferential currents at the cervical level. Pain related measures (Visual Analogue Scale oral, Pressure Pain Threshold (PPT)), vertical mouth opening as primary outcome measures and cervical range of motion as secondary outcomes were assessed. The assessments were made before the intervention, immediately after and after 4 weeks of follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 14, 2021
• Est. primary completion date: November 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consent of the subject to participate in the study.
• A primary diagnosis of myofascial pain according to Axis I, category Ia and Ib (i.e. myofascial pain with or without limited opening) of the Research Diagnostic Criteria for TMD (RDC / TMD) (Schiffman E, Ohrbach R, Truelove E, et al. Diagnostic criteria for tempormandibular disorders (DC(TMD) for clinical and research applications: recommendations of the International RDC/TMD consortium network* and orofacial pain special interest group. J Oral facial pain headache. 2014;28(1):6-27").
• Bilateral pain involving the masseter and temporal regions; presence of at least one trigger point (TrP) in the masseter muscle.
• Pain symptoms history of at least the 3 months previous to the study.
• Intensity of the pain of at least 30 mm on a 100 mm Visual Analogue Scale (VAS).
• A score of less than 45 points on the Personal Psychological Apprehension Scale (PPAS). It has been validated in the scope of physiotherapy, and represents a simple-to-handle tool in studies where subjects may undergo electrotherapy as a treatment option.

Exclusion Criteria:

• Surgical intervention of the temporomandibular joints (TMJ).
• Suffering some intra-articular damage (arthritis) or some vestibular disorder diagnosed.
• Inflammation of the TMJ.
• Having received physiotherapy treatment in the last two weeks.
• Receive pharmacological treatment for analgesic, anti-inflammatory or that could cause alterations of equilibrium.

Related Conditions & MeSH terms

• Disease
• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Group 1: Manual Therapy
The treatment techniques used will be: ischemic compression in the trigger point of the masseter and soft-tissue release technique over the temporal region.
• Group 2: Interferential massage plus Manual Therapy
In addition to the treatment techniques applied to the other group, an electric massage will be performed with interferential currents at the level of the cervical region.

Locations

Country	Name	City	State
Spain	Luis Espejo Antúnez	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
Luis Espejo Antúnez PhD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the assessment of the maximum amplitude of the vertical opening of the mouth:	The maximum vertical opening of the mouth was measured using a manual gauge. The measurements were taken with the subjects placed in the supine position on the stretcher, with the head resting on it, the cervical spine in a neutral position, knees slightly bent and the upper limbs extended along the body.; In this position, we ask participants to open their mouths as much as possible without causing pain. In this way, we obtain the measurement in millimeters the distance between the upper and lower central incisors.	Immediately after the intervention as well as 4 weeks after the intervention.
Primary	Changes in the assessment of pain intensity: VAS	To measure pain, the visual analog scale (VAS) has been used. The VAS scale is an instrument used very often to quantify the intensity of pain. The accuracy and validity of the EVA scale as a measure of pain has been demonstrated previously.; Participants were asked to indicate the degree of pain intensity in response to manual palpation of the central trigger point of the masseter bilaterally using a 10 cm analogue visual scale where 0 corresponds to "no pain" and 10 to "worst pain" that you can imagine. " When performing the post-treatment assessment, a period of 1 minute of rest was left to prevent the change of position from influencing the data obtained, especially in the displacements of the pressure center.	Immediately after the intervention as well as 4 weeks after the intervention.
Primary	Changes in the valuation of pain threshold to pressure.	To measure the pain threshold to the pressure in muscle trigger points, a manual algometer with 1 cm2 of contact area was used. The algometer serves to record the minimum amount of pressure needed for the sensation of pressure to change to a sensation of pain. When this moment arrives, the subject will say "already" and the algometer immediately withdrawn, the pressure being recorded. The results obtained will be expressed in kg / cm2 (1,8).; The muscles assessed were masseter and superior trapezius, both bilaterally in the supine position. The pressure in both must be done in a direction perpendicular to the muscle fibers. In the case of the upper trapezius, the algometer will be placed on the trigger point 1 described by Travell and Simons (9). In the masseter, the pressure perpendicular to the algometer will be applied on the central trigger point of the superficial portion of said muscle as described by Travell.	Immediately after the intervention as well as 4 weeks after the intervention.
Secondary	Changes in the assessment of cervical range of motion.	The goniometry is used to evaluate the range of joint movement. The range of cervical movement can be evaluated with many instruments, but the goniometer offers a simple and low cost alternative for evaluation.; In this case, for the measurement of the range of cervical movement we will use a universal goniometer that presents a scale of measurement in degrees. The patient will be placed in a sitting position in a chair and we will give him the order to perform the movement to be evaluated. The movements to be evaluated will be right and left rotation, flexion, extension and right and left side bending. We will prevent the patient from making compensations with other body regions.	Immediately after the intervention as well as 4 weeks after the intervention.