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Rajiv Gandhi University of Health Sciences, Karnataka,
Bangalore.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 Name of Candidate
& Address ILLAHI ZAHOOR KINUCHATTABAL, GUZERBAL, SRINAGAR,KASHMIR, J &K.
2 Name of the Institution DAYANANDA SAGAR COLLEGE OF PHYSIOTHERAPY
3 Course of study and subject MASTER OF PHYSIOTHERAPY (Physiotherapy in Musculoskeletal disorders & Sports physiotherapy)
4 Date of admission to course June;2012
5 TITLE OF THE TOPIC:
EFFECT OF ULTRASOUND VERSUS TRANSCUTANEOUS ELECTRICAL NERVE
STIMULATION ON PAIN IN TEMPOROMANDIBULAR JOINT DYSFUNCTION
(OCCLUSIVE MUSCULAR LEVEL) –A COMPARATIVE STUDY.
6 Brief resume of the intended work:
6.1 INTRODUCTION
Temporomandibular joint disorder (TMD) is a generic term to describe a group of disorders or
diseases affecting masticatory muscles, the Temporomandibular joint (TMJ) and associated
structures1. Epidemiologic studies show that approximately 75% of the population have some TMD
sign, while 33% have at least one symptom.2
Study showed that people with TMD can experience severe pain and discomfort that can be
temporary or last for many years. More women (6.3%) than men (2.8%) experience TMD. TMD is
most common in people between the ages of 20-40. The prevalence of TMD is between 3-15% in the
General population with an incidence between 2-4%.3
Temporomandibular Disorders (TMD) is a collective term embracing all the problems relating to
Temporomandibular joint (TMJ) and related musculoskeletal masticatory structures4. It refers to a
cluster of disorders characterized by pain in the preauricular region, pain in TMJ, or the masticatory
muscles, limitation or deviations in mandibular range of motion and noises in the TMJ during
mandibular function. TMJ disorders are also sometimes referred to as Myofascial pain dysfunction,
Craniomandibular Disorder and Costen's syndrome.5
The Temporomandibular Joint (TMJ) is the site of articulation between the mandible and the skull,
specifically the area about the articular eminence of the temporal bone. The articulation consists of
parts of the mandible and temporal bones, which are covered by dense, fibrous connective tissue and
are surrounded by several ligaments. The TMJ is a synovial, condylar and hinge-type joint with fibro
cartilaginous surfaces rather than hyaline cartilage and an articular disc. The disc completely divides
each joint into two cavities. The joint connects the lower jaw (mandible) to the temporal bone of the
skull.6
The joints are flexible, allowing the jaw to move smoothly up and down and side to side and enabling
one to talk, chew and yawn. Muscles attach to and surround the jaw joint to control the position and
movement of the jaw. The muscles include masseter, temporalis, medial pterygoid and later
pterygoid.7 Because muscles and joints work together, a problem with either one can lead to following
TMJ disorders. Teeth grinding and teeth clenching (bruxism) increase the wear on the cartilage lining
of the TMJ. Many patients awaken in the morning with jaw or ear pain, Habitual gum chewing or
fingernail biting, Misalignment of the teeth (malocclusion), Trauma to the jaws: Previous fractures in
the jaw or facial bones can lead to TMJ disorders, Problematic relation between the jaw and
malocclusions with deflective contacts in the teeth, Stress frequently leads to unreleased nervous
energy. It is very common for people under stress to release this nervous energy by either consciously
or unconsciously grinding and clenching their teeth, Occupational tasks or habits such as holding the
telephone between the head and shoulder may contribute to TMJ disorders.8
Symptoms associated with TMD are: pain or tenderness of the aching pain in and around the ear,
difficulty chewing or discomfort while chewing, aching facial pain, locking of the joint, difficultly
with opening or closing of the mouth, headaches, uncomfortable bite, or uneven bite. Clicking,
popping or grating sounds in the joint with opening and closing of the mouth. Other common
symptoms include toothaches, neck pain, dizziness, earaches and hearing problems.9
Piper’s Classification Of TMJ Disorders:
Piper I: Normal disc and ligaments
Piper II: Normal disc position; ligaments torn or stretched
Piper IIIa: Partial displacement of the disc, reduces on opening; ligaments torn or stretched
Piper IIIb: Partial displacement of the disc, nonreducing on opening; ligaments torn or stretched
Piper IVa: Full dispacement of disc, reduces on opening; ligaments torn or stretched
Piper IVb: Full displacement of disc, nonreducing on opening; ligaments torn or stretched
Piper Va: Bone-to-bone contact; active degeneration
Piper Vb: Bone-to-bone contact; bone has become eburnated10
TMD handling may be simple or may require a multidisciplinary approach. Dentists, physicians,
psychologists and physical therapists work together to cope with such condition afflicting patients.
Clinical treatment is considered the first choice11. Numerous physical therapy methods are effective to
treat TMD, such as moist heat, ultrasound, TENS, microwaves, laser, exercises and manual therapy
techniques12. These methods aim at decreasing musculoskeletal load and pain effects, at decreasing
inflammation, at restoring normal joint function (strength, movement and resistance) and at helping
return to daily activities.13
TENS is the method by which controlled, low voltage electrical pulses are applied to the nervous
system. TENS is used to reduce the symptoms of pain. Secondary benefits, such as sedation and
increased tissue temperature, are noted; however, the primary effect of TENS is to produce analgesia.
TENS therapy stimulate large, fast ,myelinated, non-nociceptive neurons in the painful area “closing
the central gate” for those stimuli generated by pain specific fibers. This system, associated to the
activation of an endogenous opioid system is supposed to be responsible for the analgesic effect of the
TENS.14
Ultrasound therapy used by physical therapists that utilize high or low frequency sound waves. These
sound waves are transmitted to the surrounding tissue and vasculature. They penetrate the muscles to
cause deep tissue/muscle warming. This promotes tissue relaxation and the warming effect of the
sound waves also cause vessel vasodilatation and increase circulation to the area that assists in
healing, decrease in pain from the reduction of swelling and edema.15
Joint vibration analysis (JVA) or Electro vibrato graphy is based on simple principles of motion and
friction. When surfaces rub together, they cause vibration. The greater the surface roughness, the
greater the vibration, and this vibration can be captured by accelerometers. Human joints have
surfaces which rub together in function. Smooth, lubricated surfaces in a proper biomechanical
relationship in theory should produce little friction and little vibration. But surface changes, such as
those caused by tissue degeneration, tears, or displacements of the disc; are thought to produce greater
friction and greater vibration. Computer assisted vibration analyses is claimed to identify these
patterns and helps distinguish among various temporomandibular disorders.Vibration analysis of the
temporomandibular joint is thus, a quantitative process that measures the absolute intensity and
frequency distribution of vibratory waves emanating from the joint as it is exercised throughout its
full range of motion. Tissue vibrations (motions) are recorded down to the level of approximately one
micron.16
JVA is a device that: 1) objectively records all of the vibrations of the underlying tissue during
function, 2) distinguishes which side the vibration originates on, 3) creates a visual image of the
vibration, 4) measures the intensity of the vibration, 5) precisely quantifies the frequency content and
6) provides a permanent record for future comparison. JVA is less invasive and more accurate than
auscultation or palpation with a repeatable permanent record of TM joint function or dysfunction.
And, it can be recorded by a staff member in about a minute.17
JVA is a great screening test since it has such a high specificity. It is also the ideal, low cost way to
monitor joint function during the course of treatment. While it does not eliminate the need for
expensive imaging, it allows the practitioner to make a more informed decision whether the cost of
imaging is justified.17
6.2 Need for the study
Temporomandibular disorders (TMDs) refer to an aggregate of clinical pain conditions that involve
the craniofacial muscles, the Temporomandibular joint and associated structures. TMDs are
considered to be a subclass of the musculoskeletal disorders and are a major source of non-dental pain
in the orofacial region.Temporomandibular joint (TMJ) dysfunction is often the cause of varied
symptoms throughout the head and neck is becoming widely recognized among health professionals.
Currently dentists are the professionals involved in TMJ evaluation and treatment. However,
procedures such as ROM measurements, muscle tests, joint play test, cervical spine evaluation and
pain relief are not usually performed by dentists but by physical therapists.
TENS is a method by which controlled, low voltage electrical pulses are applied to the nervous
system. TENS is used to reduce the symptoms of pain. Several studies have been done to studies have
been done to study the effectiveness of TENS on pain relief in TMD.
Similarly therapeutic ultrasound has been a widely used and well accepted physical therapy adjunct
modality particularly for the management of musculoskeletal conditions. Few studies have been done
to study the efficacy of therapeutic ultrasound on pain in TMJ.
But no study has been done till date comparing which modality between therapeutic ultrasound and
TENS is more effective in reducing pain in TMJ dysfunction. So, this this study has been done to
compare whether therapeutic ultrasound or TENS is more effective in reducing pain in TMJ
dysfunction
6.3 Hypothesis :
Null Hypothesis: There will be no significant difference between Transcutaneous electrical nerve
stimulation and Ultrasound Therapy on pain in patients with Temporomandibular dysfunction at the
OML.
Experimental Hypothesis: There will be significant difference between Transcutaneous electrical
nerve stimulation and Ultrasound Therapy on pain in patients with Temporomandibular dysfunction
at the OML.
6.4 Review of Literature:
OUTCOME MEASURES
Joint Vibration Analysis:
Sharma, Sonia (2011). This observational study was designed to evaluate the clinical reliability and
diagnostic validity of the Joint Vibration Analysis (JVA) in patients with disc displacement with
reduction. The short term reliability of the JVA outcome variables showed excellent results, the
Intraclass correlation coefficients (ICCs) ranged from 0.63 to 0.90. A sensitivity of 48% and
specificity of 94% was obtained for the correct identification of subjects with and without disc
displacement with reduction.18
Visual Analogue Scale:
Polly E. Bijur, Phd, Wendy Silver, Ma, E. John Gallagher, Md;(2001). The objective of the study
was to assess the reliability of the VAS for measurement of acute pain. And it was concluded that
Reliability of the VAS for acute pain measurement as assessed by the ICC appears to be high.19
Ruler For ROM:
Nancy Walker, Richard W. Bohannon, Denise Cameron (2000). This study was done to determine
the discriminant validity and intrarater and interrater reliability of measurements of
temporomandibular joint (TMJ) range of motion (ROM) with ruler. Mouth opening was the only TMJ
ROM measurement to discriminate between subjects with and without TMJ disorders (mean 36.2 2
6.4 versus 43.5 2 6.1 mm). The technical error of measurement of the measures varied from .2 to 2.5
mm. lntrarater reliability coefficients (ICC 3,l) varied from .70 to .99. Interrater reliability coefficients
(ICC 2,k) varied from .90 to 1 .O. Although all TMJ ROM measurements tended to be reliable, only
mouth opening was found to be valid in discriminating between patients with and without a TMJ
disorder).20
TEMPOMANDIBULAR JOINT DYSFUNCTION
Shalender Sharma, D. S. Gupta, U. S. Pal, and Sunit Kumar Jurel ; (2011). This study concluded
that there is successful management of temporomandibular disorders is dependent on identifying and
controlling the contributing factors. The temporomandibular disorders are more common in females,
the reason is not clearly known.21
Edward F. Wright, Sarah L. North; (2009). This study concluded that routinely managed by
medical and dental practitioners, TMD may be more effectively cared for when physical therapists are
involved in the treatment process. Hence, a listing of situations when practitioners should consider
referring TMD patients to a physical therapist can be provided to the practitioners in each physical
therapist’s region.22
Milan Knežević, Miranda Guillermo, Mario Vicente1, Garcia Francisco, Sergio Dominguez,
Slađana Petrović et al;(2008). this study deals with conservative non-surgical treatment of painful
temporomandibular joint (TMJ) syndrome administered in thirty patients. The treatment involved
TENS applications, and particularly extension exercises of the masseter muscle, temporalis and
pterygoid muscles, as well as the local application of ultrasound. The result was an evident
improvement in a significant number of cases. Physical exercises represent a useful treatment
modality for TMPDS patients. TMPDS treatment should be organized in a multidisciplinary way,
with dentists, physiotherapists and psychologists being all equally involved.23
Marega S Medlicott and Susan R Harris;(2006). This systematic review analysed studies
examining the effectiveness of various physical therapy interventions for Temporomandibular
disorder and it was concluded that the following active exercises and manual mobilizations postural
training, mid-laser therapy, relaxation techniques and biofeedback, electromyography training, and
proprioceptive re-education and combinations may be effective.24
Margaret L McNeely, Susan Armijo Olivo and David J Magee ;( 2006). The purpose of this
qualitative systematic review was to assess the evidence concerning the effectiveness of physical
therapy interventions in the management of Temporomandibular Disorders. Most of the studies
included in this review were of very poor methodological quality, there is a clear need for well-
designed RCTs examining physical therapy interventions for TMD. Trials should be large enough to
be clinically meaningful and include valid and reliable outcome measures. Based on the positive
effects of active and passive exercise, postural exercises, and manual therapy, high-quality trials with
larger sample sizes are clearly warranted in these areas.25
INTERVENTION
Eduardo Grossmann, Joseane Steckel Tambara, Thiago Kreutz Grossmann, José Tadeu
Tesseroli de Siqueira;(2012). This article aimed at reviewing the scientific literature on the use of
TENS in Temporomandibular joint patients. TMD has different aetiologies and specific treatments,
among them the transcutaneous electrical nerve stimulation (TENS) is used which administers
electrical current to the skin surface, to relax hyperactive muscles and promote pain relief. And futher
it was concluded that Although there are controversies about the use of TENS to control chronic pain,
its use for masticatory muscle pain is still relevant. However, an accurate diagnosis is needed to
prevent its inadequate use. There is still need of controlled randomized studies including selected
samples to homogenize the use of TENS in TMD patients.26
Ali Jakubowski;(2010). This study compares articles using manual therapy and exercise in treating
adults with Temporomandibular mandibular joint . Both studies yielded evidence for incorporating
manual therapy directed at the cervical spine and TMJ as an intervention for adults with TMD or TMJ
pain. However, further research is needed with a more appropriate control group, in order to accept
any potential results and generalize the results to general clinical population.27
Bart Craane, Antoon De Laat, Pieter Ulrike Dijkstra, Karel Stappaerts, Boudewijn Stegenga;
(2009).The objectives of the study was to determine the effectiveness of physical therapy in (specific
subgroups of ) Temporomandibular disorder (TMD). And to investigate the relative effectiveness of
the different physical therapy modalities and it was concluded that due to lack of blinding process and
further limitations there were no significant results found to prove effectiveness of various physical
therapy interventions over each other.28
Rita A Wong, Britta Schumann, Rose Townsend, Crystal A Phelps;(2007). This study aims to
find out effectiveness on Ultrasound for management of various musculoskeletal conditions as there
is a lack of scientific evidence on its effectiveness. And it was concluded that Ultrasound continues to
be a popular adjunctive modality in orthopaedic physical Therapy, the respondents indicated that they
were likely to use US to decrease soft tissue inflammation (eg, tendinitis, bursitis) (83.6% of the
respondents), increase tissue extensibility (70.9%), enhance scar tissue remodelling (68.8%), increase
soft tissue healing (52.5%), decrease pain (49.3%), and decrease soft tissue swelling (eg, edema, joint
effusion) (35.1%). The study provides summary data of the most frequently chosen machine
parameters for duty cycle, intensity, and frequency. These findings may help researchers prioritize
needs for future research on the clinical effectiveness of US.29
Melissa Thiemi Kato; Evelyn Mikaela Kogawa; Carlos Neanes Santos; Paulo César Rodrigues
Conti ;(2006). This research compared two treatments in a sample of 18 patients with chronic TMD
of muscular origin, divided into two groups (LASER and TENS). Pain relief and reestablishment of
normal jaw function are the main goals of conservative management of Temporomandibular
Disorders (TMD).And it was concluded that Within the limitations of this study, Both therapies were
effective for decreasing the symptoms of TMD patients, regardless of the type of device used. The
cumulative effect may be responsible for this improvement, since it is just observed after several
sessions, whereas the immediate effect was not significant. Further clinical studies must be performed
to evaluate the real efficacy of physical therapy modalities.30
Debora Bevilaqua Grossi1, Thais Cristina Chaves ;(2004). This systemic review focuses on to a
correct approach for effective physiotherapeutic intervention for treatment of Temporomandibular
joint intervention. And it was concluded that Manual therapy, therapeutically resources (like as ultra-
sound, TENS) and postural re-education must be applied in a physical therapy treatment for TMD
patients are effective, but an appropriate intervention should be related not only to symptoms relief,
but look for TMD´s etiology.31
P Nicolakis,B Erdogmus, M Nicolakis,E Piehslinger , V Fialka-Moser;(2002). The objective of
this study is to find out effectiveness of exercise therapy in patients with myofascial pain dysfunction
syndrome, the treatment protocol consisted of active passive jaw movement exercises, correction of
body postures and relaxation techniques and further it was concluded that exercise therapy seems to
be useful in the treatment of MPD syndrome.32
R J Gray, A A Quayle, C A Hall & M A Schofield;(1994). This study aims a comparative
evaluation of four different physiotherapy treatments and placebo in the management of TMJPDS and
comments on their cost benefit aspects compared with that of splint therapy. The four methods of
physiotherapy tested were short-wave diathermy, megapulse, ultrasound and soft laser. And it was
concluded that there was no statistically significant difference in success rate between any of the four
tested (range 70.4–77.7%) although each individually was significantly better than placebo
treatment.33
6.5 Objectives of the study:
To find out effect of Ultrasound therapy on pain in patients with Temporomandibular joint
dysfunction
To find out effect of Transcutaneous nerve stimulation on pain in patients with
Temporomandibular joint dysfunction
To compare the effect of Ultrasound versus Transcutaneous electrical nerve stimulation on
pain in patients with Temporomandibular joint dysfunction
7 Materials and Methods:
7.1 Source of Data
Physiotherapy Clinic, Dayananda Sagar College of Physiotherapy, Bangalore.
Dayananda Sagar Dental Hospital And Research Centre, Bangalore.
7.2 Method of collection of data:
Population :Subjects with Temporomandibular joint Dysfunction
Setting :Hospital and Out Patient Department
Sample design : Convenience Sampling
Sample size : 50
Type of Study : Experimental with pre-post test design (Comparative)
Duration of the study : 6 months
7.3 Inclusion Criteria:
Those who were willing to participate in the study and willing to take treatment for 10 days
Unilateral involvement
Clinically patients diagnosed with Temporomandibular joint dysfunction
Age group = 19 - 60 years
Both genders included in the study
Piper’s Classification II, IIIa and IIIb are included
7.4 Exclusion Criteria:
History of trauma or injury around Temporomandibular joint
Patient on Analgesic and Anti-inflammatory Drugs
Patient wearing any removable prosthesis
Patients with Degenerative TMJ Arthritis
Patients with Inflammatory TMJ Arthritis
Patients with Infective TMJ Arthritis
Malignant Tumors or Cancer of face and Jaws
History of dislocation of Jaw
History of previous surgery of Jaw and TMJ
Ankylosed of TMJ
Hypermobile TMJ
Neurological involvement
7.5 Material used:
Couch/Treatment table
TENS Machine
Therapeutic Ultrasound Machine
Ultrasound Gel
Cotton
Micropore Tape
Towels
Pen/Paper
Measuring tools: Visual Analogue Scale (VAS).
Ruler
JVA (Joint vibration analyser or Electro vibrato graphy)
7.6 Methodology
Intervention to be conducted on the participants:
Subjects will first be screened and those diagnosed with TMD disorders using JVA will be included
for the study. Patients who meet the inclusion criteria will be assigned to two groups based on
convenient sampling, group A and group B. Informed consent will be taken from all subjects prior to
participation. Instructions will be given to the patients about technique performed. This will be
followed by subjective as well as objective assessment of the involved TMJ area for tenderness,
temperature, swelling, pain and its intensity in terms of the Visual analogue scale (VAS). In addition
to this functional assessment based on ROM will be carried out using ruler.
A total of 50 participants will be selected and will be assigned into Group A (n=25) and Group B
(n=25) by simple random sampling. Interventions will be given for 3 days/week for 4 weeks. At the
completion physical therapy sessions outcome measures will be re-evaluated and pre and post scores
will be compared.
Group A: Ultrasound therapy and Relaxations techniques for facial muscles.
Therapeutic Ultasound: The skin surface to be treated should be clean, free of oil and dirt, properly
exposed and inspected; inflammatory skin conditions should be avoided, and the nature of treatment
will be explained to the patient. Ultrasound will be applied over the TMJ area. The patient should be
in the comfortable position so that the area to be treated is accessible. The couplant should be applied
to the skin surface. The treatment head is moved continuously over the surface while even pressure is
maintained in order to iron out the irregularities in a sonic field the emitting surface must be kept
parallel to the skin surface. Participants will be treated with Ultrasound with the output of
0.5W/cm2 for 5 minutes using a pulsed mode 1: 4 ratio with frequency of 3MHz for 3 days/week for 4
Sweeks.34
The following facial muscle Relaxation exercises will be followed:
Position of the patient will be sitting.
o Place the tip of the tongue on hard palate behind the front teeth and draw little circles
on the palate.
o Place the tip of the tongue on the hard palate and blow air out to vibrate the tongue
making an “r r r” sound.
o Fill the cheeks with air (mouth closed); then let the air out in a puff.
o Make a “clicking” sound with the tongue on the roof of the mouth.35
Frequency: 3 times a day, 8-10 repetitions, for 4 weeks.35
Group B: TENS and Relaxation techniques for facial muscles.
TENS: The skin surface to be treated should be clean, free of oil and dirt, properly exposed and
inspected; inflammatory skin conditions should be avoided, and the nature of treatment will be
explained to the patient. The patient should be in the comfortable position so that the area to be
treated is accessible. Participants will be treated with TENS which will be given through 2 carbon
electrodes(40 x 54 mm2) will be placed over TMJ region with frequency at 50Hz, with pulse width of
0.5mSec, where intensity as per patient tolerance for 15 minutes for 3days/week for 4 weeks.36
The following facial muscle Relaxation exercises will be followed:
o Place the tip of the tongue on hard palate behind the front teeth and draw little circles
on the palate.
o Place the tip of the tongue on the hard palate and blow air out to vibrate the tongue
making an “r r r” sound.
o Fill the cheeks with air (mouth closed); then let the air out in a puff.
o Make a “clicking” sound with the tongue on the roof of the mouth.35
Frequency: 3 times a day, 8-10 repetitions, for 4 weeks.35
Outcome measures:
Visual Analogue Scale (VAS).
Range Of Motion
JVA (Joint vibration analyser or Electro vibrato graphy)
Statistics: Statistical analysis will be performed by using SPSS software for windows (version 17) &
probability value (p value) will be set as 0.05
Descriptive statistics will be used to find out mean, standard deviation for demographic & outcome variable.
Paired t-test will be used to find out homogenecity for baseline & demographic & ratio outcome variable within the group.
Unpaired t-test will be used to find out homogenecity for baseline & demographic & ratio outcome variable between the group.
Wilcoxon Signed Rank test will be used to find out the significant difference for ordinal scale within the groups.
Mann-Whitney U test will be used to find out the significant difference for ordinal scales between the groups.
Microsoft word, excel will be used to generate graphs & tables, etc.
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9 Signature of Candidate
10 Remarks of the Guide
11 Name and Designation of
11.1 Guide : Dr. Anil T. John
11.2 Signature
11.3 Co-Guide : Dr. Sujoy Kumar
11.4 Signature
11.5Head of Department : Dr. Anil T. John
11.6 Signature
12 12.1Remarks of the Chairman & Principal
12.2Signature
DAYANANDA SAGAR COLLEGE OF PHYSIOTHERAPY
THE INSTITUTIONAL ETHICAL COMMITTEE
ETHICAL CLEARENCE CERTIFICATE
The Institutional Ethical Committee of Dayananda Sagar College of Physiotherapy
has reviewed the research proposal of Mr. ILLAHI ZAHOOR KINU, MPT
student, Dayananda Sagar College of Physiotherapy, Kumaraswamy layout,
Bangalore –78, certificates that the research proposal is ethically satisfactory.
Reference: Ethical guide lines for biomedical resource on human Council Of
Medical Research.
New Delhi- 2000
CHAIR PERSON SECRETARY
Basic medical scientists:-
1)
2)