Electrostimulation Therapies With Implementation of Multifractal Electromyographic Analysis

Summary

The objective is to compare the neuromuscular electrical activity and muscle fatigue of the masseter muscles in three groups of patients with different treatments for TMD (GA = Transcutaneous electrostimulation and splint, GB = percutaneous electrostimulation and splint, and GC = Occlusal splint) by means of 6 electromyographic recordings scheduled weekly.

The study population will be patients with TMD who will enter the Physiology Laboratory of the Division of Postgraduate Studies and Research (DEPeI) UNAM, admitted during the period from March to December 2021 The selection of the sample will be carried out by convenience sampling which will be carried out based on the clinical evaluation (considering the inclusion and exclusion criteria). The recruitment period will take place during the period from March to December 2021.

The selected sample will be divided into three groups (GA = transcutaneous electrostimulation and splint, GB = percutaneous electrostimulation and splint, GC = splint); the allocation by group will be made by means of a randomization in balanced blocks. The total sample size calculated for this study was 84 patients, 28 for each group.

The diagnostic process of Temporomandibular Dysfunction (TMD) will be carried out by the Principal Investigator using the Diagnostic Criteria and Investigation of Temporomandibular Disorders (CDI / TMD).

Conditions

• Temporomandibular Dysfunction (TMD)
• Orofacial Pain

Interventions

COMBINATION_PRODUCT

Transcutaneus electrostimulation therapies

Sterile steel acupuncture needles of 0.25x13mm, disposable AcuBEST brand, and portable electro-stimulator equipment KWD- will be used. The superficial area of the skin of the masseter muscle will be cleaned with alcohol. Two needles will be placed in each masseter muscle, the area to be punctured is the origin of the masseter muscle or superficial area of the mandibular condyle anterior to the atrial tragus approximately 1cm away, insertion of the masseter muscle at the angle of the mandible. The two double alligator cables will be connected to the head of the needles. The positive pole will be connected at the origin of the masseter muscle and the negative pole at the insertion. The parameters to be used will be are two frequency bands (210Hz-10140Hz.); amplitude 3050 volts, pulse duration: 40100 msec; and the output intensity: 0.70 (for 100Hz). The treatment time will be 20 minutes.

COMBINATION_PRODUCT

Percutaneus electrostimulation therapies

Kendall® MediTrace 100 conductive adhesive ECG electrodes (pediatric) 2.4 cm in diameter, and portable KWD-808 electrostimulator equipment will be used. The superficial area of the skin will be cleaned, two electrodes will be placed on each muscle (superficial area of the mandibular condyle and at the angle of the jaw). The current leads will then be connected to the KWD-808 electroacupuncturist to the patient. Current will be transmitted with a square waveform, 210Hz-10140Hz of frequency, 3050 volts of amplitude and 40100 msec pulse time. The treatment time will be 20 minutes.

DIAGNOSTIC_TEST

Oclusal splint

The occlusal splint is worn 24 hours a day, removed for eating and brushing teeth. It is washed with neutral liquid hand soap. For the preparation, an impression of the maxillary dental arches will be taken with alginate; It is made with acetate .060 and .080. Relining is done with self-curing acrylic on the occlusal surface of the splint

Sponsors & Collaborators

• Universidad de la Republica

  collaborator OTHER

• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

  collaborator OTHER_GOV

• Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad Irapuato

  collaborator OTHER

• Facultad de Estudios Superiores Iztacala, UNAM.

  collaborator UNKNOWN

• Universidad Nacional Autonoma de Mexico

  lead OTHER

Principal Investigators

• Julio Morales, Bachelor · Universidad Nacional Autonoma de Mexico

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2022-08-01

Completion

2022-12-01