Randomized Clinical Trial of Electrostimulation Therapies With Implementation of Multifractal Electromyographic Analysis for Patients With Temporomandibular Disorders
Phase: NA
Conditions: Temporomandibular Dysfunction (TMD), Orofacial Pain
Sponsor: Universidad Nacional Autonoma de Mexico

 
UNIVERSIDAD NACIONAL AUTÓNOMA DE MÉXICO  
 
UNIVERSIDAD NACIONAL AUTÓNOMA DE MÉXICO 
 
Master's and Doctorate Program in Science 
Medical, Dental and Health 
 
Research protocol for Clinical Trials.gov 
 
Randomized clinical trial of electrostimulation 
therapies with an electromyographic multifractal 
analysis device for patients with 
temporomandibular disorders 
 
Rodríguez Castañeda Claudia Ivonne 
Ángeles Medina Fernando 
 
January 7th, 2021 
 
NTC ID: Not yet assigned 
ID: CIE/0508/02/2020 
 

Randomized clinical trial of electrostimulation therapies with an 
electromyographic multifractal analysis device for patients with 
temporomandibular disorders 
 
Introduction 
Temporomandibular dysfunction or disorder (TMD) is a functional disorder of the 
temporomandibular joint (TMJ), and is the cause of non-dental pain in the orofacial region. 
TMD presents diagnostic difficulties, the literature suggests objective assessment of neuromuscular 
activity. Electromyography (EMG) is a reliable tool to determine the degree of functional muscle 
alteration, the EMG signal can be estimated and characterized by multifractal analysis, for example, 
the Hurts Index. This method is used successfully in the study of physiological signals with high 
biological variability (signals: cardiac, cardiovascular, ophthalmological, neuronal, metabolic, etc.), it 
is considered suitable for the comprehensive analysis of neuromuscular behavior. (1-3) (1) 
The main objective of TMD treatment is to restore chewing function with splints being the first 
choice; however, complementary therapies are recommended for the relief of signs and symptoms. 
Electrostimulation has been reported to produce favorable analgesic effects in the treatment of TMD. 
Electrostimulation can be applied in two ways; transcutaneous and percutaneous, both produce 
muscle contraction by activating the nervous system. However, the degree of activation determines 
the magnitude of the effect on organic functions. The clinical results obtained depend on the selected 
point to be stimulated, as well as the stimulus method used and the duration of the stimulus. The 
transcutaneous route known as Transcutaneous Electrical Nerve Stimulation (TENS) produces 
indirect contraction of the muscle belly in a superficial way with the use of electrodes and the 
percutaneous route called Percutaneous Neuromodulation Therapy (NPT) produces direct 
stimulation of the muscle fibers through the insertion of needles. (electroacupuncture). 
The objective of this study is to compare the neuromuscular effect produced by transcutaneous and 
percutaneous electrostimulation therapies as adjuvants in the treatment of TMD through the use of 
an occlusal splint in patients from the Physiology Laboratory of the Division of Graduate Studies and 
Research (DEPeI ) UNAM. 
Theoretical framework 
The American Association defines temporomandibular dysfunction (TMD) as a group of functional 
alterations of the masticatory system. (4) Worldwide they are the second most frequent skeletal 
muscle condition and between 7 and 15% of the adult population is affected, it is a functional disorder 
of the temporomandibular joint (TMJ). (5-6) (5) (6) 
It is identified by the presence of muscle or joint pain, joint noises, and restriction, deviation, or 
deflection in the mandibular opening. (7) It is the main cause of non-dental pain in the orofacial region 
(8), it is estimated that 75% of the population has had some sign throughout their life and 33% some 
symptom of these; 30% are diagnosed and only 5 to 10% request treatment (9). It occurs between 

20 and 40 years of age with greater frequency in women (ratio of 3: 1 to 6: 1) (10). The etiology of 
TMD is diverse and is associated with parafunctional habits, psychosocial disorders, inflammatory 
disorders, infectious problems, trauma, and hormonal changes. (10) 
TMD presents diagnostic difficulties complicating treatment planning (6-7). The literature suggests 
objective assessment of masticatory function and frequent monitoring of neuromuscular activity 
through electromyography studies. (eleven) 
Electromyography (EMG) is a reliable tool to determine the degree of muscle functional alteration 
(12); it is an auxiliary for the diagnosis and treatment of TMD. The electromyographic analysis tools 
offered by modern digital systems are: RMS (root mean square), DFA (detrended fluctuation analysis) 
MAV (mean absolute value), ARV (average rectified value) and MNF (mean frequency). Most EMG 
signals are based on the analysis of their stochastic characteristics in time and frequency. (13) The 
EMG signal exhibits a chaotic behavior which can be estimated by its fractal dimension using non-
linear techniques, for example, the Hurst index. This method has been used successfully in the study 
of physiological signals with high biological variability and is considered suitable for the 
comprehensive analysis of neuromuscular behavior. (14) 
The main goal of treating TMD is to restore function; the clinical challenges are; reduce or eliminate 
joint pain and / or noise and regain normal jaw movement. Currently there are different types of 
treatments such as the use of occlusal splints, pharmacological treatments, infiltrations, arthroscopy, 
arthrocentesis or surgery. Splints are the first-line treatment with a conservative and valuable 
approach in the remission of signs whose objective is to generate functional stability (15), frequently 
it is complemented with the use of drugs for the remission of symptoms (16). The American Academy 
of Orofacial Pain recommends analgesic focus therapies with the use of an occlusal splint, for 
example: 
muscle 
stretching 
and 
exercises, 
trigger 
point 
injections, 
electrotherapy 
(electrostimulation), dry needling (acupuncture), or massage therapy. These alternatives reduce pain, 
restore function, and some reduce stress and anxiety. (17) 
Myofascial pain is myogenic in origin and it has been reported to decrease significantly with electrical 
stimulation, which has analgesic and anti-inflammatory effects on the muscles (18); the physiological 
mechanism by which electrical currents act is known as "gate theory." When electrical stimuli are 
administered, Aβ fibers are activated, modulating the nervous system and interrupting the 
transmission of nociceptive information. The results obtained with electrical stimulation depend on 
the selected point to be stimulated, the stimulus method used and the duration of the stimulus. (19) 
Different therapies based on the same principle are applied in dentistry and it has been observed 
that the degree of activation determines the magnitude of the effect on organic functions, for 
example, the inhibition of pain. (20) Studies differ on the location of the area to be stimulated, the 
length of time the stimulus should last, and the amount and frequency of therapies. (21) For the 
treatment of TMD, electrostimulation can be applied through two main routes; transcutaneous and 
percutaneous; both produce muscle contraction by activating the nervous system. The 
transcutaneous route known as Transcutaneous Electrical Nerve Stimulation (TENS) produces 
indirect contraction of the muscle belly in a superficial way with the use of electrodes. The 

percutaneous route, also called Percutaneous Neuromodulation Therapy (NPT), produces direct 
stimulation of muscle fibers through the insertion of needles (electroacupuncture). (22) 
Transcutaneous Electrical Nerve Stimulation, also called transcutaneous electrostimulation, consists 
of the application of electrical current to the skin with surface electrodes. Which is endorsed by the 
Food and Drug Administration (FDA) (23) as an effective method for the treatment of pain (24) the 
FDA recommends its use under the direction of a health professional (25) The mechanism of action 
of transcutaneous electrostimulation consists of activating nerve endings in the skin (26) producing 
changes at the cerebral and cortical level, altering the neural axis. (27) 
Percutaneous Neuromodulation Therapy or percutaneous electrostimulation also called 
electroacupuncture, acts by administering direct electrical current to deep muscle tissues and 
stimulates thick afferent fibers (sensory fibers) located at the origin of pain. 
(28) (29) The World Health Organization (WHO) concluded that chronic facial pain including 
craniomandibular disorders respond well to acupuncture treatment (electroacupuncture). 
Electrostimulation is approved for the treatment of chronic pain by the National Institutes of Health 
in the United States, Germany, and the United Kingdom. (27-31) The mechanism of action results 
from a multifactorial process triggered after stimulation of demyelinated nerve fibers, activating 
three main regulatory centers (the spinal cord, the midbrain, and the hypothalamic-pituitary axis) 
responsible for neuromodulation. Regulates sensory, motor and autonomic functions and involves 
the interaction of neurotransmitters of the nervous system (endogenous opioids with the substance 
P, 
acetylcholine, 
serotonin, 
norepinephrine, 
and 
gamma-aminobutyric 
acid 
(GABA)). 
Electroacupuncture is considered less invasive than transcutaneous electrical stimulation due to its 
ability to act on the central nervous system. (30) 
Background 
The literature refers that the treatment of temporomandibular disorders is complex due to the 
variability of signs and symptoms in each patient. The current approach involves the implementation 
of techniques typical of complementary medicine for the relief of the main signs (joint noise and 
mandibular dysfunction) and recurrent symptoms (myofascial and / or joint pain) of this pathology. 
(7) 
They have suggested various treatment modalities in the management of TMD. These recommended 
therapies include different types of interocclusal appliances, occlusal adjustment, physical therapy, 
jaw exercises, acupuncture, transcutaneous electrical stimulation, cognitive-behavioral therapies and 
pharmacological interventions (31-32) (31) (32) 
The results of the efficacy of splints have shown that the success of the treatment is not clearly 
explained as a specific therapy, however it is the most commonly applied treatment modality in 
dentistry for TMD (33) In the United States a survey showed that the Most dentists treating patients 
with TMD preferred to wear hard splints. (34) This modality is the primary approach and is generally 
used as adjunctive therapy to control the associated symptoms of TMD. (35) 

Although not conclusive, the results of the studies support the decompressive effect produced by the 
use of a splint, suggesting that it uniformly elevates the occlusal plane, displaces the bite force vector 
distally and decreases the length of the resistance arm in relation to the arm of the splint. effort by 
reducing the force directed at the TMJ. (36) 
Only a few studies focused on occlusal splint therapy have been reported and therapeutic success is 
affected by the dentist's lack of knowledge of TMD, the duration of therapy, the type of splint and 
the occlusal adjustment. (37) 
A systematic review article published in 2007 (Macedo CR, Silva 2007) affirms that the splint is 
effective to treat TMD or bruxism, however it questions that its use may be limited in the complete 
remission of symptoms, justifying the use of physical therapies as adjuvants in the treatment of TMD. 
(38) The use of physical therapies such as electrostimulation are therapeutic aids that produce 
analgesic and muscle relaxation effects. 
Controlled studies have been reported with the application of transcutaneous electrostimulation 
therapies in patients with severe symptoms of TMD, which reported a significant decrease in 
myofascial pain, muscle and joint sensitivity measured by visual analog scale (VAS) after four 
transcutaneous electrostimulation therapies. . (28 and 30) 
However, other authors conducted clinical trials to evaluate mandibular function evaluating signs of 
TMD. They reported an increase in mouth opening of 4 to 6 mm (p = 0.002) after transcutaneous 
electrostimulation therapies and observed a decreasing trend in the TENS study group after a few 
weeks. (36-37) 
Percutaneous electrostimulation is a modality frequently used in Traditional Chinese Medicine (TCM) 
widely used in the treatment of various health ailments, it is one of the most studied and documented 
therapeutic modalities in the field of medicine, the mechanism of action has resulted controversial 
despite the fact that positive effects are observed from the moment in which the puncture is 
performed. The results depend on the selected point to be stimulated, the stimulus method used and 
the duration of the stimulus. (39) 
At present this practice has spread and various types of therapies have been generated. (20) 
Auriculotherapy, Electro Acupuncture (EA) and trigger point injections (Ashí Point), are some types 
of acupuncture therapies that exert analgesic action for the treatment of TMD. However, EA offers 
advantages over manual acupuncture because parameters such as intensity, frequency, and duration 
of the stimulation pulse can be reliably standardized. (18) (40) 
Some studies carried out in patients with TMD evaluated the analgesic efficacy of electro 
acupuncture compared with a control group (use of a splint) which showed a significant decrease in 
the levels of muscle and joint pain, with an increase in jaw function compared to the control group. 
(25 and 39) 
The low frequency and high intensity stimuli generated by these therapies release β-endorphins and 
decrease pain favorably, studies have been reported comparing the frequency and intensity in TMD 
therapies by modifying the time of electrical stimulation in each group, reported that the 85% of the 

patients in the group with continuous electrostimulation (20 minutes) presented symptoms of 
immediate relief at the end of therapy. (41) 
The table shows the results obtained from the treatments for TMD using transcutaneous and 
percutaneous electrostimulation and the use of a splint: 
 

Transcutaneous electrical stimulation for the treatment of TMD 
  
N 
Sample Features 
Interventions 
Therapeutic 
application 
Variables 
Results 
Seifi 
(2017) 
40 
18-50 years 
Headache and / or 
neck 
pain. 
Sensitivity 
to 
palpation 
in 
the 
auricular 
area. 
Mouth 
opening 
limitation 
Group. study: 
TENS therapy  
(n = 20) 
Control group: 
Therapeutic Laser 
 (n = 20). 
30 minutes 
4 session per 
week 
4 sessions  
• 
Maximum 
mouth 
opening (mm) 
• 
Head and Neck Pain 
(EVA) 
• 
Muscle 
sensitivity 
(EVA) 
• 
Joint sensitivity (EVA) 
• 
Maximum 
mouth 
opening: 
NS 
differences between groups 
• 
Analog visual scale (VAS): Decrease (p = 
0.000) in the TENS group 
• 
Muscle sensitivity: Decrease (p = 0.000) in 
the TENS group 
• 
Joint sensitivity: Decrease (p = 0.000) in 
the TENS group 
Ferreira 
 (2017) 
40 
20-65 years 
Chronic pain (RDC / 
TMD) 
• 
Group. study: 
TENS Therapy 
(n = 20) 
• 
Group. study: 
TENS Placebo 
(n = 20) 
50 minutes 
1 session per 
week 
 1 sessions 
• 
Muscle pain (EVA) 
• 
Palpation muscle pain 
sensitivity (EVA) 
• 
VAS: Decrease (p> 0.05) in group of 
placebo TENS 
• 
Palpation 
muscle 
pain 
sensitivity: 
Increase in masseter and temporal 
muscles in the TENS group (p> 0.05) 
 
 
 

Percutaneous electrical stimulation for the treatment of TMD 
  
N 
Sample Features 
Interventions 
Therapeutic 
application 
Variables 
Results 
Vera  Zotelli 
(2017) 
40 
20 a 60 años 
Disfunción 
temporomandibular 
(Dolor orofacial y/o 
Limitación 
a 
la 
apertura bucal) 
  
• 
Group. study: 
Acupuncture  
          (n = 20) 
• 
Control group: 
Acupuncture 
placebo (n = 
20)  
55-65 minutes 
1 session per 
week 
4 sessions  
• 
Orofacial pain (EVA) 
• 
Mouth opening (mm) 
• 
Energy 
in 
the 
meridians 
by 
(Ryodoraku) 
• 
The placebo group had no decrease in 
pain (p = 0.2261), nor an increase in 
mouth opening comparison (p = 0-05) 
• 
Post-acupuncture 
energy 
level 
decreased in Yang channels in all 
sessions 
Jiang-hong 
(20019) 
40 
20 to 60 years 
Myogenic 
temporomandibular 
dysfunction  
• 
Group. study: 
Acupuncture  
          (n = 20). 
• 
Control group: 
Occlusal splint 
          (n = 20) 
20 minutes 
1 session per 
week 
4 months  
• 
Electromyographic 
muscle effect 
• 
Pain 
intensity: 
EVA 
(Beginning and end of 
treatment)) 
• 
VAS: decreased equally in the two 
groups (p = 0.001) 
• 
Right 
temporal 
muscle 
intensity 
decreased in the final stage of the splint 
group (p = 0.005) 
• 
Both groups decreased pain intensity 
short term (2 weeks) 
 
 
 

Definition of the problem 
Treatment of TMD is complex due to the variability of signs and symptoms; The use of an occlusal 
splint is the treatment of first choice for the stomatologist, however, this alone does not have the 
capacity to eradicate all the symptoms. The literature suggests the use of complementary therapies 
to restore chewing function. 
Electrostimulation therapies produce favorable effects in the treatment of TMD. Electrostimulation 
can be applied in two ways: transcutaneous and percutaneous; however, the clinical results obtained 
depend on the technique used. 
The neuromuscular effect of transcutaneous and percutaneous electrostimulation therapies has not 
been reported as adjuvants in the treatment of TMD through the use of an occlusal splint; The 
electromyographic evaluation with the multifractal analysis tool will determine the neuromuscular 
effect produced by the therapies, objectively evaluating the effectiveness of each one. 
Research question 
What is the neuromuscular effect produced by transcutaneous and percutaneous electrostimulation 
therapies as adjuvants in the treatment of TMD compared to the use of an occlusal splint in patients 
of the Laboratory of Physiology of the Division of Graduate Studies and Research DEPeI, UNAM? 
Justification 
TMD is the main cause of non-dental pain in the orofacial region. It is important to optimize 
conventional treatment (use of an occlusal splint) for the complete remission of the symptoms; As 
well as evaluating the neuromuscular effect produced by electrostimulation therapies as an adjunct 
in the treatment of TMD. 
The literature suggests the objective assessment of chewing function by electromyography for the 
diagnosis and during treatment of TMD. 
General purpose 
To compare the neuromuscular electrical activity (RMS) and muscle fatigue (Hurst index) 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. ) through 6 electromyographic records scheduled weekly in patients from the 
Physiology Laboratory of the Division of Graduate Studies and Research (DEPeI) UNAM, admitted 
during the period from August to December 2020. 
Specific objectives 
o Register the sociodemographic and clinical variables (age, sex, TMD, BMI, systemic diseases, use of 
prostheses, number of teeth present, drug intake) prior to TMD treatment in patients admitted to 
the DEPeI UNAM Physiology Laboratory during the period from August to December 2020. 
o Record the neuromuscular electrical activity (RMS) and muscle fatigue (Hurst Index) of the masseter 
muscles of the 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 (T0 = Basal, T1 = 7 days, T2 = 
14 days, T3 = 21 days, T4 = 28 days, T5 = 35 days, T6 = 42 days) in patients from the Laboratory 
Physiology of the DEPeI, UNAM, admitted during the period from August to December 2020. 
o Record TMD signs and symptoms (muscle pain, joint pain, mouth opening limitation, presence of 
joint sounds and heart rate) during TMD treatments through 6 weekly scheduled evaluations (T0 = 
Baseline, T1 = 7 days , T2 = 14 days, T3 = 21 days, T4 = 28 days, T5 = 35 days, T6 = 42 days) in patients 
from the Physiology Laboratory of DEPeI, UNAM, admitted during the period from August to 
December 2020. 
o Identify the changes in neuromuscular electrical activity (RMS) and muscle fatigue (Hurst Index) of 
the masseter muscles in each group (GA = Transcutaneous electrostimulation and splint, GB = 
percutaneous electrostimulation and splint, and CG = Occlusal splint) during the TMD treatment (T0 
= Baseline, T1 = 7 days, T2 = 14 days, T3 = 21 days, T4 = 28 days, T5 = 35 days, T6 = 42 days) in patients 
from the Physiology Laboratory of DEPeI, UNAM, admitted during the period from August to 
December 2020. 
o Compare the changes in neuromuscular electrical activity (RMS) and muscle fatigue (Hurst index) 
of the masseter muscles by group (GA = Transcutaneous electrostimulation and splint, GB = 
percutaneous electrostimulation and splint, and GC = Occlusal splint) during treatment of TMD (T0 = 
Basal, T1 = 7 days, T2 = 14 days, T3 = 21 days, T4 = 28 days, T5 = 35 days, T6 = 42 days) in patients 
from the DEPeI UNAM Physiology Laboratory, admitted during the period from August to December 
2020. 
o Identify the changes in TMD signs and symptoms (muscle pain, joint pain, limitation of mouth 
opening, presence of joint sounds and heart rate) in each group (GA = Transcutaneous 
electrostimulation and splint, GB = percutaneous electrostimulation and splint, and CG = Occlusal 
splint) during DTM treatment (T0 = Basal, T1 = 7 days, T2 = 14 days, T3 = 21 days, T4 = 28 days, T5 = 
35 days, T6 = 42 days) in patients from the Laboratory of Physiology of the DEPeI UNAM, admitted 
during the period from August to December 2020. o Compare the changes in TMD signs and 
symptoms (muscle pain, joint pain, limitation of mouth opening, presence of joint sounds and heart 
rate) by group (GA = Transcutaneous electrostimulation and splint, GB = Percutaneous 
electrostimulation and splint, and CG = Occlusal splint) during DTM treatment (T0 = Baseline, T1 = 7 
days, T2 = 14 days, T3 = 21 days, T4 = 28 days , T5 = 35 days, T6 = 42 days) in patients from the DEP 
Physiology Laboratory eI UNAM, admitted during the period from August to December 2020. 
o Identify the changes in neuromuscular electrical activity (RMS) and muscle fatigue (Hurst Index) of 
the masseter muscles in each group (GA = Transcutaneous electrostimulation and splint, GB = 
percutaneous electrostimulation and splint, and CG = Occlusal splint) during the treatment of TMD 
according to the sociodemographic and clinical variables (age, sex, TMD, BMI, systemic diseases, use 
of prostheses, number of teeth present, drug intake), in patients from the DEPeI UNAM Physiology 
Laboratory, admitted during the period from August to December 2020. 
o Compare the changes in neuromuscular electrical activity (RMS) and muscle fatigue (Hurst index) 
of the masseter muscles by group (GA = Transcutaneous electrostimulation and splint, GB = 

percutaneous electrostimulation and splint, and GC = Occlusal splint) during treatment of TMD 
according to the sociodemographic and clinical variables (age, sex, TMD, BMI, systemic diseases, use 
of prostheses, number of teeth present, drug intake), in patients of the Physiology Laboratory of 
DEPeI, UNAM, admitted during the period from August to December 2020. 
 
Hypothesis 
Ha1: There will be a greater decrease in neuromuscular electrical activity (RMS) and muscle fatigue 
(Hurst index) of the masseter muscles in the treatment group with percutaneous electrostimulation 
(GB = percutaneous electrostimulation and splint) compared to the values of the electrostimulation 
groups transcutaneous (GA = transcutaneous electrostimulation and splint) and the control group 
(CG = Occlusal splint) of patients from the Physiology Laboratory of the Division of Postgraduate 
Studies and Research (DEPeI), UNAM, admitted during the period from August to December 2020 . 
 Ho1: There will be no decrease in neuromuscular electrical activity (RMS) and muscle fatigue (Hurst 
index) of the masseter muscles in the treatment group with percutaneous electrostimulation (GB = 
percutaneous electrostimulation and splint) compared to the values of the electrostimulation groups 
transcutaneous (GA = transcutaneous electrostimulation and splint) and the control group (CG = 
Occlusal splint) of patients from the Physiology Laboratory of the Division of Graduate Studies and 
Research (DEPeI) UNAM, admitted during the period from August to December 2020. 
 
Material and methods 
Type of study 
Randomized clinical trial 
Study population 
Patients with TMD who will enter the Physiology Laboratory of the Division of Graduate Studies and 
Research (DEPeI) UNAM, during the period from August to December 2020. 
The DEPeI UNAM Physiology Laboratory attends approximately 900 patients per year, of which 168 
first-time patients are referred from other specialty clinics at DEPeI UNAM. Around 100 appointments 
are scheduled per month, most of them are for treatment controls through occlusal splint adjustment 
and electromyographic records. The patients received by the Physiology Laboratory are referred by 
the Reception and Diagnosis Clinic (Postgraduate), the specialty clinics of the DEPeI, stomatological 
services of hospitals and private clinics, among others. 
Selection and sample size 
The selection of the sample will be carried out by a convenience sampling which will be carried out 
based on the clinical evaluation (considering the inclusion and exclusion criteria) in patients with a 
diagnosis of TMD who will enter the DEPeI Physiology Laboratory during the period from August 2020 
to December 2020. 

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. 
The recruitment period will be carried out during the period from August to December 2020, patients 
with a diagnosis of temporomandibular dysfunction (TMD) will be recruited who will enter the 
Physiology Laboratory of the Division of Postgraduate Studies and Research (DEPeI) UNAM, during 
the period from August to December 2020. The diagnosis of TMD will be carried out by the main 
researcher (Doctoral Student of the Master's and Doctoral Program in Dental and Health Medical 
Sciences) using the Diagnostic and Research Criteria for Temporomandibular Disorders (CDI / TTM) . 
(50) (Annex 1 and 2) 
Sample size calculation 
The characteristic analysis used to analyze the comparison of means in more than two groups 
corresponds to the one-way analysis of variance (ANOVA). (51) The sample size was estimated for 
ANOVA (Sample size For ANOVA). 
Since the means are unknown, the background of the research is used: Camargo in 2018 (48), reports 
the electromyographic changes (RMS) of the trapezius muscles of four study groups with different 
treatments (G1 = superficial electro acupuncture, G2 = deep stimulation of trigger points, G3 = 
combination of acupuncture and electro acupuncture and G = 4 control group), before and after 
treatment. 
For the sample size calculation, only the RMS values after the treatment used in groups 1, 2 and 4 
were taken. 
Electromyographic values (RMS) of the trapezius muscle of the three groups studied. 
Group 1 (Transcutaneous) 
Group 2 (Percutaneous) 
Control group  
96.55µV.  
85.38 µV.  
86.82 µV.  
87.45 µV.  
65.37 µV.  
80.25 µV.  
92.51 µV.  
95.1 µV.  
83.02 µV.  
84.31 µV.  
74.11 µV.  
74.99 µV.  
 
DESCRIPTION 
Alpha 
0.05 
Group 
Count 
Sum 
Mean 
Variance 
SS 
Std Err 
Lower 
Upper 
grupo 1 
4 
360.82 
90.205
29.3043667 
87.9131 4.30742221 
80.460934 
99.949066 

grupo 2  
4 
319.96 
79.99
168.561 
505.683 4.30742221 
70.245934 
89.734066 
grupo control 
4 
325.08 
81.27
24.7812667 
74.3438 4.30742221 
71.525934 
91.014066 
ANOVA 
Sources 
SS 
df 
MS 
F 
P value 
F crit 
RMSSE 
Omega Sq 
Between Gro u 247.758467 
2 123.879233 1.66918176 0.24178662 4.25649473 0.6459840 9 0.10033941 
Within 
Groups 
667.9399 
9 
74.2155444
Total 
915.698367 
11 83.2453061 
 
Sample size calculation for three-group ANOVA. 
The total sample size calculated for this study was 75.46 patients, 25 for each group. As it is a 
longitudinal study, losses are considered for the duration of treatment (6 weeks). An oversampling 
of the general n was estimated, increasing the n by 10%, having a final sample size of: n total = 84 
patients in total n group = 28 patients in each group 
Inclusion, exclusion and elimination criterio: 
 
Inclusion criteria: 
 o Patients assigned to the DEPeI Physiology Laboratory admitted during the period from August to 
December 2020. 
o Patients without prior TMD or TMD treatment o Patients in an age range between 18 to 60 years o 
Patients with permanent dentition o Patients with malocclusion o Patients with deviation when 
opening or closing the mandible o Patients with presence of articular noises in function 
o Patients with myofascial or joint pain o Patients with prosthetic or implant treatments o Patients 
with partially edentulous arches o Bruxist patients 
Exclusion criteria: 
 o Patients with periodontal problems o Patients with orthodontic treatment or use of dental braces 
o Patients with apparent neurological or sensory disabilities o Patients with bleeding disorders or 
with ingestion of anticoagulants o Patients with pacemakers, defibrillators or cardiac pathologies o 
Patients with epilepsy, thrombophlebitis, Active or uncontrolled phlebitis o Patients with the 
presence of facial wounds or severe acne o Patients with neurological or muscular disorders o 
Patients allergic to metal o Patients with infections or acute inflammatory processes o Pregnant 
patients o Patients with a history of joint surgery o Patients with malignancies o Patients with 
degenerative bone diseases o Patients with fibromyalgia o Patients with mental disorders 
Elimination criteria: 
  

o Patients who do not wish to continue with electrostimulation therapies and / or the use of a splint. 
o Patients who, during TMD treatment, require dental restorations or root canals. 
o Patients who during TMD treatment suffer from some type of dental trauma or fracture. 
Control group selection 
The randomization of the total sample (84 patients) will be carried out to obtain the three study 
groups (28 patients per group) including the control group (CG = Occlusal splint). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients who will enter the DEPeI Physiology 
Laboratory 
(January-August 2021) 
Patients diagnosed with DTM by CDI / TTM 
Study sample 
(n = 84 patients) 
Inclusion, exclusion and 
elimination criteria 
Randomization by: 
Balanced Blocks 
Study Group (GA) 
(n = 28 patients) 
Transcutaneous electrostimulation and 
occlusal splint 
Study Group (GB) 
(n = 28 patients) 
Percutaneous electrostimulation and 
occlusal splint 
Control Group (GC) 
(n = 28 patients) 
Occlusal splint 

 
Variables (identification, definition, measurement scale) 
 
 
 
 
 
 
 
 
 
 
 
 
Systemic diseases 
Diagnosed systemic alteration that the patient responds to 
the question "Do you have any systemic disease?" when 
making the medical history. 
➢ 
Information obtained from the medical history 
1. 
Diabetes 
2. 
Arterial hypertension 
3. 
Rheumatoid arthritis 
4. 
Diabetes and Hypertension 
Drug intake 
Taking medications prescribed by medical indication for 
some type of systemic alteration. 
➢ 
Information obtained from the medical history 
1. 
Not 
2. 
Yes 
Use of prosthetics 
Use or presence of removable oral prosthesis at the time of 
clinical evaluation. 
➢ 
Information obtained when conducting the 
clinical evaluation 
1. 
Total upper arch prosthesis 
2. 
Total lower arch prosthesis 
3. 
Total prosthesis both arches 
4. 
Removable partial upper arch prosthesis 
5. 
Removable lower arch partial denture 
6. 
Removable partial denture both arches 

Number of teeth 
present 
Number of teeth present in the mouth at the time of the 
clinical examination 
➢ 
Information obtained when conducting the 
clinical evaluation 
1. 
1 to 8 teeth 
2. 
9 to 16 teeth 
3. 
17 to 24 teeth 
4. 
25 to 32 teeth 
DTM Treatment 
Type of therapy that the patient receives for 6 weeks for the 
treatment of DTM. 
1. 
Transcutaneous electrostimulation therapy and 
occlusal splint 
2. 
Percutaneous electrostimulation therapy and 
occlusal splint 
3. 
Occlusal splint 
 
Variables of signs and symptoms of DTM 
Variable 
Definición operacional 
Escala de medición 
Muscle pain 
Amount of muscular pain reported by the patient when applying a 
pressure of 1.5 Kg / cm2 in masseter muscles and 2.4 Kg / cm2 in 
temporal muscles using a circular tip of a Baseline brand pressure 
algometer. (52) 
➢ 
Information obtained with visual analog scale when 
conducting the clinical evaluation. 
0 to 10 
Where 0 represents the absence of perceived pain, and 10 
the maximum amount of pain 
Joint pain 
Amount of joint pain reported by the patient when applying a pressure 
of 1.5 Kg / cm2 to the surface area of the ATM using a circular tip of a 
baseline pressure algometer. (52) 
➢ 
Information obtained with visual analog scale when 
conducting the clinical evaluation. 
0 to 10 
Where 0 represents the absence of perceived pain, and 10 
the maximum amount of pain 
Limitation of 
mouth opening  
Amount of millimeters measured from the incisal edge of the upper 
anterior teeth to the incisal edge of the lower anterior teeth with a 
TeraBite ruler. 
➢ 
Information obtained when conducting the clinical 
evaluation 
Millimeters (mm) 
1. 
Normal opening (> 40mm) 
2. 
Opening limitation (<40mm.) 
Presence of joint 
noises  
Sound detected and recorded by the operator using a stethoscope 
placed in the anterior atrial area above the TMJ when making 
mandibular opening and closing movements. 
➢ 
Information obtained when conducting the clinical 
evaluation 
1) 
Not 
2) 
Yes 

Heart rate  
Number of times the heart beats for one minute, measured with  using 
a finger oximeter Pulox Oxímetro de Pulso PO-200  
Information obtained when conducting the clinical evaluation 
Number of beats 
Norm (60-100 beats) 
 
Information gathering methods (selection of sources, methods, techniques and 
procedures): 
 Convenience samplings will be carried out, based on the evaluation of the clinical history, radiological 
studies (orthopantomography and comparative radiography of the TMJ open and closed mouth) and 
clinical examination, in patients of the Physiology Laboratory of the DEPeI UNAM, who will be 
admitted during the period from August to December 2020. 
The diagnostic process of Temporomandibular Dysfunction (TMD) will be carried out by the Principal 
Investigator (Doctoral Student of the Master's and Doctoral Program in 
Medical, Dental and Health Sciences) in patients who come to request service from the 
Laboratory of Physiology of the Division of Postgraduate Studies and Research (DEPeI) of the School 
of Dentistry UNAM (UNAM) during the period from August to December 2020. Mtra. Claudia Ivonne 
Rodríguez Castañeda (Principal Investigator) carried out the calibration process for the diagnosis of 
temporomandibular disorders based on the diagnostic criteria of the American Dental Association, 
under the mentorship of Doctor Marcelo Kreiner at the Laboratory of Physiology of Dentistry of the 
University of the Republic, Uruguay. (Annexed 2) 
The use of diagnostic criteria for the investigation of temporomandibular disorders (CDI / TMD) will 
be used (54). The instrument allows a physical examination and medical history in two axes. Axis I, 
based on a clinical examination divided into: a) muscular disorders b) disc displacements and, c) 
arthralgia, arthritis, osteoarthritis. The second axis comprises a questionnaire based on disabilities 
due to chronic pain and psychological aspects. (fifty) 
Once the diagnosis is made, a protocolized algorithm is used for CDI / TMD scores (axis I and axis II) 
and thus determine the Diagnostic classification of TMD. (1.- muscular TMD, 2.- joint TMD, 3.- 
inflammatory TMD) (50) 
After the diagnosis of TMD, a general clinical evaluation will be carried out to establish whether they 
meet the inclusion criteria, all patients who meet the characteristics described and who wish to 
participate in the study will sign an informed consent. After being included, a general, regional and 
local clinical examination will be carried out to collect baseline data for the study variables. 
Data collection will be by primary technique and direct method through interviews (series of 
questions asked during the anamnesis for the complete record of the clinical history), observation 
(dental clinical evaluation) and digital surface electromyography, all carried out in a chair. at the DEPeI 
Physiology Laboratory, UNAM. This procedure will be performed by a previously trained and 

standardized examiner and annotator (Cohen's Kappa 0.7), for a clearer performance of the clinical 
examination and the reduction of bias by the examiner for clinical methods. For the clinical 
examination, it will be performed in clockwise order, starting with the upper right quadrant. The first 
review will correspond to the presence of mixed dentition, use of prostheses, number of teeth, 
muscle pain (with a pressure algometer applying 1.5 kg / cm2 in masseter muscles, and 2.4 kg / cm2 
in temporal muscles), joint pain (with algometer pressure applying 1.5 kg / cm2), presence of noises, 
limitation to mouth opening (with Terabite) and heart rate. 
 To assess pain by means of muscle and joint palpation with an algometer, the patient will be seated 
in a relaxed position, the evaluator will place the fine circular surface of the algometer perpendicular 
to the skin and an increasing pressure of 0.5 kg / cm2 will be applied increasing gradually over one 
minute until reaching 1.5 kg / cm2. 
The patient will be instructed to verbalize the moment when pressure was exerted if a painful 
sensation was caused by muscle and in the joint area. 
 The treatment for TMD will be carried out by means of the conventional treatment with an occlusal 
splint and as an auxiliary method, transcutaneous and percutaneous electrostimulation therapies will 
be applied by the same operator during the period from August 2020 to June 2021. The appointments 
for clinical control for signs and symptoms of TMD , splint adjustment, electromyographic records 
and application of electrostimulation therapy as an adjunct to the use of splint, will be scheduled 
once a week in the Physiology Laboratory from 9:00 am to 1:00 pm and from 2:00 pm to 6:00 pm: 
00pm for six consecutive weeks. 
• Electromyographic recording technique 
The registration system (hardware and software) that will be used for the electromyographic 
evaluation is the Electromyograph 1.2 UNAM-CINVESTAV, which consists of a two-channel system for 
the analysis of the electromyographic signal that offers greater precision and facilitates muscle 
assessment through the estimation made by the software of the RMS for its acronym in English (Root 
Mean Square) and Hurts Index. (53) 
The RMS and Hurts Index will be recorded using three electrodes: one placed at the muscular origin, 
another at the insertion, and finally one in the behind-the-ear area as a ground or neutral electrode. 
The RMS recording is performed at maximum intercuspation for 30 seconds; the action potential that 
is expressed in electrical energy will be recorded in microvolts per second (μV / s). 
 6 electromyographic recordings will be performed on each patient (one record each week) during 
the time of splint use. Electromyographic recordings will be scheduled as well as follow-up control 
appointments, to make adjustments to the physiological occlusal splint. 
Occlusal splint fabrication technique 
The occlusal splints for the treatment of TMD will be the same for all the participants, they will be 
made by the Principal Investigator in the Physiology Laboratory of DEPeI, UNAM. The indications for 
the use of a splint and hygiene will be the same in all patients (the splint is worn 24 hours a day, it is 

removed for eating and brushing teeth). The splint is washed with neutral liquid hand soap, no 
brushing or scrubbing). 
To make the occlusal splint, an impression of the maxillary dental arches will be taken with alginate; 
the positive will be obtained with type IV stone plaster. Once the plaster has set, the models will be 
obtained to make the splint with a thermoplastic vacuum machine. A .060 "acetate sheet will be 
placed, and the second acetate will be a .080" caliber. Once the acetate sheet has been adapted to 
the working model, it will be cut with a carbide disk on the design previously made on the plaster 
model, marking the middle part of all the upper teeth on the buccal part to have the guide cutting. 
Surpluses will be removed with the help of a bur and polished to avoid damage to the soft tissues 
with a blanket wheel. Once this is done, he will test the patient to check that it does not generate any 
discomfort. Later it will be adjusted again to the working model to carry out the relining. 
Relining is done with self-curing acrylic on the occlusal surface of the splint, leveling the amount of 
material on a glass tile. Then the occlusal adjustment is made with the help of articulating paper and 
thus achieve a homogeneous occlusal bite. Excess acrylic will be removed and placed back in the 
mouth to verify the dimension of the splint (interdental unocclusion), taking care that it does not 
interfere with any mandibular movement. It is finished by polishing the splint with the help of a 
blanket wheel and polyacril. 
Transcutaneous electrical stimulation technique 
The transcutaneous electrostimulation therapies will be carried out by the Principal Investigator, who 
will be trained in the ISSSTE Clinic Specialties East Leonardo Bravo Complex in the acupuncture service 
under the supervision of Dr. Roberto Sánchez Ahedo. (Surgeon, Specialist in Family Medicine. Training 
in acupuncture in different institutions. Master's in Medical Education, Doctorate in Education, 
Professor of various courses in acupuncture from a medical perspective. Academic of the Faculty of 
Medicine of UNAM.) 
For transcutaneous electro stimulation therapy, Kendall® MediTrace 100 conductive adhesive ECG 
electrodes (pediatric) with a diameter of 2.4 cm, and portable electro-stimulator equipment KWD-
808 (professional equipment for electroacupuncture and rehabilitation) will be used. 
The patient will be positioned on the dental chair, the superficial area of the skin of the masseter 
muscle will be cleaned with alcohol and cotton. Two Kendall® MediTrace 100 electrodes will be 
placed in each masseter muscle (right and left), considering the same references that were used for 
the electrodes placed for the electromyographic recording; the first electrode is placed at the origin 
of the masseter muscle or superficial area of the mandibular condyle and the second at the insertion 
of the masseter muscle at the angle of the mandible. After placing the electrodes, the KWD-808 
electroacupuncture device will be connected to the patient by means of two double alligator cables; 
the alligators will be pressed to the metal head of each electrode: the positive pole (red color) will be 
connected at the origin of the masseter muscle and the negative pole (black color) at the insertion of 
the masseter muscle. 
Before nerve stimulation, all patients will be informed of the perceived sensation, which in some 
patients will range from imperceptible to barely noticeable or not very noticeable. 

The parameters to be used will be: pulse duration until sensory activation and high intensities, but 
with an established limit to prevent muscle contraction and that allows maximum comfort for 20 
minutes. Current will be transmitted with square or rectangular waveform, the stimulation 
frequency: two frequency bands (low: 210Hz and high 10140Hz.); wave amplitude: 3050 volts, pulse 
duration: 40100 msec; and the output intensity: 0.70 (for 100Hz). The treatment time will be 20 
minutes; the equipment has the quality of timing itself and after time it will stop transmitting a signal 
to the patient. The treatment will consist of the application of six consecutive therapies programs 
weekly. 
Percutaneous electrical stimulation technique 
The transcutaneous electrostimulation therapies will be carried out by the Principal Investigator, who 
will be trained in the ISSSTE Clinic Specialties East Leonardo Bravo Complex in the acupuncture service 
under the supervision of Dr. Roberto Sánchez Ahedo. (Surgeon, Specialist in Family Medicine. Training 
in acupuncture in different institutions. Master's in Medical Education, Doctorate in Education, 
Professor of various courses in acupuncture from a medical perspective. Academic of the Faculty of 
Medicine of UNAM.) 
For percutaneous electrostimulation therapies, sterile steel acupuncture needles of 0.25x13mm, 
disposable AcuBEST brand (FDA 510K), and portable electrostimulator equipment KWD-808 
(professional equipment for electroacupuncture and rehabilitation) will be used. 
Prior to the placement of therapy, the superficial area of the skin of the masseter muscle will be 
cleaned with alcohol and cotton. The puncture technique will be carried out by taking the needle 
through the body (not by the handle), the lower part is held between the thumb and index finger of 
the right hand, allowing the tip of the needle to pass. Directing the needle to the acupuncture point 
to insert it quickly (penetrating 5 mm). 
Two needles will be placed in the right masseter muscle and two in the left masseter muscle each at 
the reference trigger points (local TMD points), following the 
"Practical recommendations for the treatment of Temporomandibular Disorders" (55); 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 (proximal acupuncture points: Gb3, Si 19, Gb 2, 
St 7), insertion of the masseter muscle at the angle of the mandible (Proximal acupuncture points: 
St6, St5). For this study, distal stitches will not be placed. 
After placing the needles, the KWD-808 electroacupuncture device will be connected to the patient; 
The two double alligator cables will be connected to each patient by means of the alligators that will 
directly press the head of the needles. The positive pole (red color) will be connected at the origin of 
the masseter muscle and the negative pole (black color) will be placed at the insertion of the masseter 
muscle. 
Before nerve stimulation, all patients will be informed of the perceived sensation, which in some 
patients will range from imperceptible to barely noticeable or not very noticeable. 

The parameters to be used will be: pulse duration until sensory activation and high intensities, but 
with an established limit to prevent muscle contraction and that allows maximum comfort for 20 
minutes. Current will be transmitted with square or rectangular waveform, the stimulation 
frequency: two frequency bands (low: 210Hz and high 10140Hz.); wave amplitude: 3050 volts, pulse 
duration: 40100 msec; and the output intensity: 0.70 (for 100Hz). The treatment time will be 20 
minutes: The equipment has the quality of timing itself and after time it will stop transmitting a signal 
to the patient. 
The treatment will be carried out every week with a total of six continuous therapies or if the patient 
deserves it until the remission of symptoms. 
Pilot test 
 A pilot test of transcutaneous and percutaneous electrical stimulation therapies will be carried out 
in a selection of 8 patients who wish to participate in the study at the DEPeI Physiology Laboratory. 
The appropriate placement of the points to be stimulated during therapy, the patient preparation 
time for therapy, the clinical examination to collect the independent variables, and the 
electromyographic recording method will be identified. 
The electromyography will identify the RMS and Hurts Index values of each recording and the changes 
in the electrical activity of the masseter muscles will be evaluated during electrostimulation and splint 
appointments. The criteria for the electromyographic recording method and its duration (30 seconds, 
measured in microvolts (µV)) will be evaluated. 
Processing record methods 
 The registration of data processing will be carried out in two stages: 
 • During the first stage, the information obtained with respect to the variables of interest will be 
recorded in the Clinical History of the Physiology Laboratory of each patient, which will be filled out 
during the clinical evaluation, electrostimulation therapies and electromyographic record in 
maximum intercuspation. 
• In the second stage, the database will be created, transferring the data recorded in the Information 
Collection Instruments format for each patient to an Excel spreadsheet, to later perform the 
statistical analysis in the statistical software Stata version 14. 
Statistical data analysis plan 
 o A descriptive analysis of the main clinical characteristics of the population studied will be carried 
out in the case of continuous variables, the mean and standard deviation or the median and its 
interquartile range will be reported according to its distribution normal and antagonistic as n and 
percentage (%). 
o The muscle effect of electrostimulation therapies within and between groups over time (before and 
during the 6 weeks of treatment), will be calculated using two-way ANOVA for repeated measures. 
Furthermore, the significant effect size of the comparison is calculated according to Cohen's effects 
(small (0.20), moderate (0.50) and large (0.80)). 

o To identify the changes in the electromyographic activity of the multifractal analysis (Hurts Index 
and RMS) recorded by time of the right and left masseter muscles of all subjects, since each subject 
will be evaluated in 6 instances weekly, multilevel models will be adjusted (56 ) to describe the effect 
of the passage of time (T0 = Baseline, T1 = 7 days, T2 = 14 days, T3 = 21 days, T4 = 28 days, T5 = 35 
days, 
T6 = 42 days) of splint use and electrostimulation therapy and the effect of different explanatory 
variables on this change as on the initial value. 
o All statistical calculations will be carried out in Stata 14 software (StataCorp., 2015). 
Organization 
a) Human resources 
 Tutor: Dr. Fernando Ángeles Medina 
Tutorial Committee: Dra. Aida Borges Yáñez and Dr. Eduardo LLamosas Hernández 
Operator: Mtra. Claudia Ivonne Rodríguez Castañeda 
External advisors: Dr. Marcelo Kreiner and Dr. Roberto Sánchez Ahedo 
b) Material resources: 
 
EQUIPOS 
INSTRUMENTAL  
MATERIAL  
STATIONERY 
(1) Unidad odontológica  
(1) Electroestimulador de 
presión “Baseline” (1) 
Electromiógrafo digital 
CINVESTAV-UNAM  
(1) Electroestimulador KWD- 
808  
(1) Computadora  
(1) Impresora  
(1) Cámara fotográfica  
(10) Diagnostic 
equipment (mirror, 
caliper, scanner) 
(3) Therbite 
(2) Algometer 
 (100) Slay Tongues 
(50) (25 packs) 
Kendall® Electrodes 
(50) (10 packs) 
Acupoint® needles 
0.025mm x 25mm 
(65) (2 boxes) Manhole covers 
(4 boxes) Gloves (5) Aerosol 
disinfectant 
(3 packs) Gauze 
(1) Alcohol 
(2 packs) Cotton 
(50) 
Medical 
record 
formats - 
Laboratory of 
Physiology 
(50) Informed consent 
forms 
(50) Data collection 
sheets 
 

c) Research development stages: 
  
I. Training stage: 
During the first, a review of the literature will be carried out and the methods of applying the 
therapies will be described. 
The training process for the application of electrostimulation therapies will be completed based on 
the WHO Guidelines established in the Official Mexican NOM-172-SSA1-1998, which specifies the 
operating criteria for the practice of human acupuncture and related methods (electrostimulation 
therapies). The Standard governs that the training of a Physician or Health Personnel to fully exercise 
these therapies requires training of at least 350 academic hours. For this reason, the main researcher 
will complete during this stage the theoretical, practical and clinical preparation course taught by the 
UNAM Faculty of Medicine "Diploma in Complementary Medicine and 
Acupuncture ”with a total of 450 academic hours lasting one year (August 2019-September 2020), to 
comply with the basic training and training guidelines for the application of electrostimulation 
therapies. 
The pilot test of transcutaneous and percutaneous electrostimulation therapies will be carried out in 
8 patients from the Physiology Laboratory. 
The recruitment phase of the sample will be carried out by evaluating the patients, the TMD 
diagnostic process and the evaluation of inclusion criteria who attend the Physiology Laboratory of 
the DEPeI UNAM during the period from August to December 2020. The randomization will be carried 
out of patients recruited during this period. 
II. Clinical stage 
The sociodemographic, clinical, signs and symptoms of TMD and neuromuscular variables of the 
patients will be measured and recorded. 
Occlusal splints will be made to start with TMD treatments 
Transcutaneous and percutaneous electrostimulation therapies will be applied 
Scheduled electromyographic recordings will be performed weekly for a period of 6 weeks. 
 III. Results analysis stage 
The database and statistical analysis of the results will be carried out 
Knowledge dissemination exercises (Article writing) 
BUDGET 
PAPIIT IT201320 project 
a) Ethical aspects: 
  

In accordance with article 17 of the regulation of the General Health Law on Health Research (SS) in 
its second title, this project is considered Research with a risk greater than the minimum: since they 
are considered: radiological studies and with microwaves and modalities that are defined in article 
65 of these Regulations, trials with new devices, procedures that use random methods of assignment 
to therapeutic schemes, for which the signing of informed consent will be essential. 
 The protocol will be submitted to the Research and Ethics Committee of the UNAM School of 
Dentistry for approval. 
The clinical methodology for the application of the therapies Transcutaneous electrical nerve 
stimulation and Percutaneous Neuromodulation Therapy will be carried out based on: 
 • OFFICIAL MEXICAN STANDARD NOM-017-SSA3-2012. Regulation of health services for the practice 
of human acupuncture and related methods. 
• Official Mexican STANDARD NOM-197-SSA1-2000. That establishes the minimum infrastructure and 
equipment requirements for hospitals and specialized medical care offices. 
 
References 
1. Muñoz A. SE, ZJ. Morphological analysis of the multifractal spectrum for the early detection of 
cardiac pathologies. Generation of new techniques for Diagnosis and Treatment; National Congress 
of Technology Applied to Health Sciences, Mexico. p. 16-18. 
2. R. C. Fractal diagnosis applied to cardiology. Rev. Colomb. Cardiol. Oct 2012; vol.19 (no.5). 
3. E. A. Fractals as a multidisciplinary reality: A projection on the field of health. Multidisciplinary 
meeting (Mathematics and Fractal Networks); 2012. p. 41. 
4. Okeson. Treatment of occlusion and temporomandibular conditions. Madrid: Elsevier Mosby; 
2003. 
5. Davies SJ GR. The pattern of splint usage in the management of two common temporomandibular 
disorders. Part III: Long-term follow up in an assessment of splint therapy in the management of disc 
displacement with reduction and pain dysfunction syndrome. Br Dent J. 1997; p. 183-200. 
6. Okeson JP. Managment of temporomandibular disorders and occlusion. 8th ed. 
Copyrighted Material: Elsevier; 2020. 
7. B. Thilander and K. Bjerklin. Posterior crossbite and temporomandibular disorders (TMDs): need 
for orthodontic treatment? European Journal of Orthodontics. 2012; p. 667673. 
8. Rodríguez N c. Temporomandibular joint dysfunction in patients aged 9 to 14 years before 
orthodontic treatment. Rev. Odont. Mex [online]. 2011 ;: p. 72-76. 

9. E. B. Effectiveness of transcutaneous electrical nerve stimulation in patients with 
temporomandibular disorder: Systematic review. Thesis. Spain: University of Lleida, Physiotrapy; 
2018. 
10. Corsini G. Temporomandibular disorders signs and symtoms determination of 13 to 18 years old 
students from a school in Temuco ,. J. Morphol .. 2005; 23 (4). 
11. Ferrario VF TG. The influence of occlusion on jaw and neck muscle activity: a surface EMG study 
in healthy young adults .. Journal of Oral Rehabilitation. 2006 .; 33 (3). 
12. Merletti & Parker A.RMP. Electromyography Physiology ,. Engineering, and Noninvasive 
Applications WileyInterscience ,. 2004. 
13. Hehan Talebinejad ADCAM. Fatigue estimation using a novel multifractal detrended fluctuation 
analysis based approach. Journal of Electromyography and Kinesiology. 2009.; 4 (3). 
14. List T HMnSCG .. Acupuncture and occlusal splint therapy in the treatment of. Swed Dent. 
1992; p. 125-141. 
15. R´e CPLDJFCaJO. The cclusal splint therapy. International Journal Stomatology and Occlusion 
Medicine ,. 2009 ;: p. 82–86. 
16. B. E. Cairns AKEWea. The use of opioid analgesics in the management of acute and chronic 
orofacial pain in Canada: the need for further research. Journal of the Canadian Dental Association. 
2014 ;: p. 49-60. 
17. Carrara PCRCaJSB. Statement of the 1st consensus on temporomandibular disorders and orofacial 
pain. Dental Press Journal of Orthodontics. 2010 ;: p. 114-120. 
18. Quiroz-González-Segura-Alegría JCGOIJEI. Cord dorsum potentials evoked by electroacupuncture 
applied to the hind limbs of rats. J Acupunct Meridian Stud. 2014,;: p. 
25-32. 
19. Disorders. Chun-En Aurea Kuo1, Szu-Ying Wu1, Yu-Chiang Hung1,2,3 and Wen-Long Hu. Taiwan: 
University College of Medicine, Fooyin University College of Nursing, Kaohsiung, Taiwan, Department 
of Chinese Medicine ,; 2017. 
20. Collazo E. Current Foundations of Acupuncture Therapy. Spanish Pain Society Magazine. 2012; p. 
325-340. 
21. Ferreira.DOGCaDP. Laser acupuncture in patients with temporomandibular dysfunction: a 
randomized controlled trial. Lasers in Medical Science. 2013 ;: p. 1549–1558. 
22. Y. C. Villalobos SHHSMDGea. Efficacy of acupuncture in temporomandibular apparatus pain-
dysfunction syndrome. Camaguey Medical Archive. 2006; p. 65-69. 

23. Administration FD. http://www.accessdata.fda.gov/scripts/medwatch/; 2017 [cited 2020 April 04. 
Available from: http://www.accessdata.fda.gov/scripts/medwatch/. 
24. La Touche. Effectiveness of acupuncture in the treatment of temporomandibular disorders 
ofmuscular origin: a systematic review of the last decade. The Journal of Alternative and 
Complementary Medicine. 2010 ;: p. 107-112. 
25. Vera Z. CM, GM. Accupunture Effect on Pain, mouth opening limitation and on the Energy 
Meridians in Patients with Temporomandibular Dysfunction: A Randomized control triall. 
Journal of Acupunter and Meridians Studies. 2017 ;: p. 351-359. 
26. Grillo CM, Could Acupuncture Be Useful in the Treatment of Temporomandibular Dysfunction ?. 
Journal of Acupuncture and Meridian Studies ,. 2015 ;: p. 192-199. 
27. Haake Mea, G. "Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, 
blinded parallei-group trial with 3 groups". Arch Intern Med. 2007 ;: p. 18921898. 
28. Barrero. The efficacy of acupuncture and decompression splints in the treatment of 
temporomandibular joint pain-dysfunction syndrome. Journal section: Orofacial PainTMJD 
Publication Types: Research. 2012 ;: p. 1028-1035. 
29. Borin G. CE, T. Acupuncture as therapeutic resource in the pain and in the severity of the 
temporomandibular disorder. Fisioterapia e Pesquisa, São Paulo ,. 2011; p. 217-22. 
30. Ferreira L. Ear acupuncture therapy for masticatory myofascial and temporomandibular pain: a 
controlled clinical trial. Hindawi Publishing Corporation. 2015 ;: p. 1-9. 
31. Okeson JP. Orofacial pain: guidelines for evaluation, diagnosis, and management. 3rd ed. 
Publishing Q, editor. Chicago (IL):: American Academy of Orofacial Pain. ; nineteen ninety six. 
32. Shedden Mora MC. Biofeedback-based cognitive-behavioral treatment compared with occlusal 
splint for temporomandibular disorder: a randomized controlled trial .. Clin J Pain.2013; 29. (1057-
1065). 
33. Conti P. Behavioral changes and occlusal splints are effective in the management of masticatory 
myofascial pain: a short-term evaluation. J Oral Rehabil. 2012; 39 (754–60.). 
34. Pierce CJ. Dental splint prescription patterns: a survey. J Am Dent Assoc. nineteen ninety five; 126 
(248-54.). 
35. Lobbezoo F AJGAKTKKLGea. Bruxism defined and graded: an international consensus .. 
J Oral Rehabil. 2013; 40 (2-4). 
36. DW. N. Intraarticular pressure in the functioning human temporomandibular joint and its 
alteration by uniform elevation of the occlusal plane .. J Oral Maxillofac Surg. 1994; 52 (7). 

37. Lundh H. Temporomandibular joint disk displacement without reduction: treatment with flat 
occlusal splint versus no treatment .. Oral Surg Oral Med Oral Pathol. 1992; 73. 
38. Macedo C. Occlusal splints for treating sleep bruxism (tooth grinding) Cochrane. 
Database Syst Rev. 2007; Four. 
39. Zhang RXea. "Electroacupuncture attenuates inflammation in a rat model". Journal Altern 
Complement Med. 2005 ;: p. 135-42. 
40. Quiroz-Gonzalez S, Depressing effect of electroacupuncture on the spinal non-painful sensory 
input of the rat. Exp Brain Res. 2014,;: p. 2721-2729. 
41. Seifi M. Comparative effectiveness of low level laser therapy and transcutaneous electric nerve 
stimulation on temporomandibular joint disorders. J Lasers Med Sci. 2017; 8 (1). 
42. Rezazadeh. Comparison of the Effects of Transcutaneous Electrical Nerve Stimulation and Low-
Level Laser Therapy on Drug-Resistant Temporomandibular Disorders. J Dent. 
Shiraz, Iran. 2017; 18 (3). 
43. Ferreira AP de L. Short-term transcutaneous electrical nerve stimulation reduces pain and 
improves the masticatory muscle activity in temporomandibular disorder patients: a randomize. J 
Appl Oral Sci. 2017; 25 (2). 
44. Rai S R. Management of myofascial pain by therapeutic ultrasound and transcutaneous electrical 
nerve stimulation: A comparative study .. Eur J Dent. 2016; 10 (1). 
45. De Giorgi I. The use of conventional transcutaneous electrical nerve stimulation in chronic facial 
myalgia patients. Clin Oral Investig .. 2017; 21 (1). 
46. Barrero M. Acupuncture and decompression splint in temporomandibular joint dysfunction. 
Journal section: Orofacial Pain-TMJD Med Oral Patol Oral Cir Bucal .. 2012 Nov; 1 (17). 
47. L. Jh. Clinical Study of Multipal Treatment on Treating Tempromandilbular Disorders. 
Chinese Archives of Traditional Chinese Medicine. 2009; 12 (2639-2641.). 
48. Camargo P. The effect of auricular and systemic acupunture on the electromyographic activity of 
the trapezius muscle with trigger points. Journal of Acupunture and Meridian Studies. 2018 Nov; 11 
(1). 
49. Yiu-kai Wong JC. A Case Series of Temporomandibular Disorders treated with 
Acupunture, Occlusal splint and Point Injection therapy. Research Gate. 2013 December; 21 (4). 
50. González Y. CE, OJ. Diagnostic Criteria for Temporomandibular Disorders. Assessment Instrument 
(Spanish). International Network and Orofacial Pain and Relades Disorders Methodology. 2014 
October. 

51. Cardenas C. AH. Statistical power and effect size calculating in g * power: complementary analysis 
of statistical significance testing and its application in psychology. health and society. 2014 May- 
August; 5 (2). 
52. Dos Santos R. PRJP. Pressure pain threshold in the detection of masticatory myofascial pain: an 
algometer-based study .. J. Orofacial Pain. 2005.; 19 (318-324.). 
53. Garcia L. Design and Construction of Electromyograph for the Surface EMG Recording of Masseter 
Muscles and Implementation of the Mutifractal Analysis by DFA. CDMX :. Thesis. CDMX: Center for 
Research and Advanced Studies of the IPN, Physiological Engineering; 2011. 
54. González Yoly. Cross-cultural adaptation of the diagnostic criteria for the investigation of 
temporomandibular disorders (CDI / TMD). Rev Fac Odontol Univ Antioq. 2013; 25 (1). 
55. Rosted. Practical recommendations for the use of acupuncture in the treatment of 
temporomandibular disorders based on the treatment of tempomandibular disorders based on the 
outcome of published controlled studies. Oral Diseases. 2001 ;: p. 109-115. 
56. Hox J. Multilevel analysis: techniques and applications. Multilevel analysis: techniques and 
applications. Erlbaum. 2002. 
57. Montalvo F&BR. Efficacy of the Mulligan movement mobilization technique in the routine 
treatment of temporomandibular dysfunction. Madrid: Comillas Madrid. 
2017 .. 
58. Savigny P, ea. Low Back Pain: early management of persistent non-specific low back pain. London: 
National Collaborating Center for Primary Care and Royal College of General Practitioners. 2009. 
59. Macpherson Hea. STRICTA Revision Group. Revised Standards for Reporting Interventions in 
Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement ”. PLoS Med. 2010,;: p. 
100-261. 
60. I RC. Evaluation of changes in electromyographic differences of masseter muscles during 
deprogramming therapy in orthodontics. Thesis. Mexico: National Autonomous University of Mexico, 
Orthodontics; 2019.