Electrostimulation Therapies With Implementation of Multifractal Electromyographic Analysis

NCT04704778 | Unknown DMC

• 1 other identifier: CIE/0508/02/2020
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Electromyographic; Electrostimulation therapy

Outcome Measures

Primary Outcomes (2)

• Neuromuscular electrical activity

  Mathematical Root Mean Square (RMS) value Micro Voltios (µV.) determined by the EMG UNAM-CINVESTAV program, which represents the average of the squared values of the electromyographic activity of the right and left masseter muscles.

  Two months (every week with a total of six continuous records)

• Muscular fatigue

  Micro Voltios (µV.) Mathematical Hurst Index value determined by the EMG UNAM-CINVESTAV program, which represents the average of the squared values of the electromyographic activity of the right and left masseter muscles

  Two months (every week with a total of six continuous records)

Secondary Outcomes (5)

• Temporomandibular dysfunction (DTM)

  Day 1

• Muscle pain

  Two months (every week with a total of six continuous records)

• Limitation of mouth opening

  Two months (every week with a total of six continuous records)

• Presence of joint noises

  Two months (every week with a total of six continuous records)

• Heart rate

  Two months (every week with a total of six continuous records)

Study Arms (3)

Transcutaneous

ACTIVE COMPARATOR

Transcutaneous electrostimulation and uso of oclusal splint

Combination Product: Transcutaneus electrostimulation therapies; Combination Product: Percutaneus electrostimulation therapies; Diagnostic Test: Oclusal splint

Percutaneous

ACTIVE COMPARATOR

Percutaneous electrostimulation and splint

Combination Product: Transcutaneus electrostimulation therapies; Combination Product: Percutaneus electrostimulation therapies; Diagnostic Test: Oclusal splint

Control

PLACEBO COMPARATOR

Oclusal splint

Diagnostic Test: Oclusal splint

Interventions

Transcutaneus electrostimulation therapies COMBINATION_PRODUCT

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.

Also known as: Electroacupuntur

Percutaneous; Transcutaneous

Percutaneus electrostimulation therapies COMBINATION_PRODUCT

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.

Also known as: TENS

Percutaneous; Transcutaneous

Oclusal splint DIAGNOSTIC_TEST

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

Also known as: Control

Control; Percutaneous; Transcutaneous

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients assigned to the DEPeI Physiology Laboratory.
• Age range 18 to 60 years
• Without prior treatment of TTM or DTM
• Permanent dentition
• With malocclusion
• With prosthetic or implant treatments
• Partially toothless arches
• Bruxists
• Deviation to mandibular opening or closure
• Presence of joint noises depending
• Myofascial or joint pain

You may not qualify if:

• Degenerative joint disease
• Periodontal problems
• Orthodontic treatment
• Apparent neurological or sensory disabilities
• Patients with bleeding disorders or with anticoagulant intake
• Patients with pacemakers, defibrillators, or heart conditions
• Epilepsy, thrombophlebitis, active or uncontrolled phlebitis
• Facial wounds or severe acne
• Apparent Neurological or muscular disorders
• Allergic to metal
• Acute inflammatory processes or infections
• Pregnant
• Joint surgical history
• Malignancies
• Degenerative bone diseases

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• Universidad de la Republica: collaborator
• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado: collaborator
• Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad Irapuato: collaborator
• Facultad de Estudios Superiores Iztacala, UNAM.: collaborator

Related Links

• Differences in masseter activity in patients with and without self-reported rheumatoid arthritis using surface electromyography: A cross-sectional study

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Julio Morales, Bachelor

  Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

Central Study Contacts

Claudia I Rodriguez, Master

CONTACT

011-552-256-225-923; dra.ivonnerodriguez@gmail.com

Fernando Ángeles, Doctoral

CONTACT

011-552-256-225-923; anfer522@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blind observer: A third party (statesman) is used, who does not know the treatment that each person is receiving. patient, to assess the response.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Clinical Dental Sciences

Model Details: 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. For this process, a series of blocks will be assembled made up of a certain number of cells in which the types of treatment are included. The number of blocks will be determined by the number of participants to be included in the study and the number of cells that it has been decided to include in each block. Each block will contain in each cell one of the treatment alternatives and within each block there must be a balanced number of possible treatments.

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: January 12, 2021
• Study Start: January 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-09