A Research Proposal 

on

Multimodal Physical Therapy Approach for the Management of Patients with Temporomandibular Disorder: Randomized Control Trial

Submitted to

LOVELY PROFESSIONAL UNIVERSITY

in partial fulfillment of the requirements for the award of degree of

DOCTOR OF PHILOSOPHY (Ph.D.) IN PHYSIOTHERAPY

FACULTY OF APPLIED MEDICAL SCIENCES

LOVELY PROFESSIONAL UNIVERSITY

PUNJAB

1.    INTRODUCTION

1.1 INTRODUCTION

TMD is considered a musculoskeletal disorder of the masticatory system that affects more than 25% of the general population.6 It is estimated that between 85 to 95 percent of population will exhibit one or more of symptoms of TMD in their lifetime

with 5 to 6 % of the population reporting clinically significant TMD related jaw pain.7,8 Cross sectional epidemiological studies in specific population showed that about 75% have at least one sign of joint dysfunction (tenderness, joint noise etc) and about 33% have at least one symptom (face pain, joint pain, muscle pain etc). Clinical

population studies have, however shown that a smaller percentage of people have problems  severe  enough  to  seek  care  for  TMD  and  those  who  sought  treatment

included more women than men by about 8 to 1. Children are affected more than the adults.7,8. 

TMD accounts for a large percent of non dental pain in the oro-facial region, with pain being one of the most frequently presenting symptoms, usually involving the muscles of mastication (temporalis, masseter, and the medial and lateral pterygoids), the pre auricular area and / or the temporomandibular joint (TMJ) 9. 

TMD disorder occurs when the muscles used in chewing, and the joints of the fail to work in combination of each other. Pathology and pain occurs when the reparative capacity of the tissue is exceeded. The etiology of TMD is widely disputed in the literature, but two major concepts, morphofunctional and psycho-physiological haveevolved.3

The morphofunctional concept links occlusal factors with TMD. These include the number of teeth in contact, loss of vertical dimension and orthodontic malocclusion (poor bite). Occlusal interferences (contact between teeth that interrupt free sliding movement of mandible) and poor intercuspal contacts (the contact between cusps of

opposing  teeth)  have  been considered  of  prime  importance.1   As  the  TMJ  are  not

intended to be stress bearing, a fairly intact dentition with an adequate intercuspal position can dissipate forces produced by the masticatory muscles during function and parafunction, while a posterior teeth loss can predispose to overloading. The mode of function of interferences and deflective contacts inducts parafunction activity and changes in the functional movement of and mandibular posture that occur as result of

subconscious avoidance of aberrant tooth contact, called aberrant function.10 

The widely accepted psycho-physiological theory states that, an injury producing activity may be initiated, resulting in an overload of the TMJ and its supporting musculature and surrounding soft tissues. These include both acute trauma (any incident that stretches and loosens the disc attachment) and chronic trauma (any factor that cause overloading of the joint or masticatory muscles. Acute traumas are overstretching from iatrogenic dental and oral surgical procedures and direct injuries to the face and jaw. Chronic trauma can arise from unilateral chewing habits, frequent mastication of hard foods, lack of occlusal stability and stress-induced muscle tension and bruxism/clenching. Inflammatory and degenerative arthritis may also precipitate

TMD.11

Pain is primarily produced by direct or indirect micro or macro trauma to a specific group of tissues, such as the joint capsule, muscle, ligament or connective tissue and prolonged pain can result in shortening and restricted motion of articular and soft tissue structures, such as TMJ capsule, muscles of mastication etc.10

TMD can be classified as joint or muscular disorder or both. Joint disorders include internal derangement, dislocation, inflammatory conditions, arthritides, ankylosis and deviation in form. Myofacial pain, myositis, spasm, splinting, and muscle contracture

comprise the muscular group.5

TMD have a wide range symptoms including restricted range of mouth opening, locking, clicking, headaches and commonly joint and muscle pain. It is also commonly associated with other symptoms affecting the head and neck regions suchas  headache,  ear-related  symptoms  and  cervical  spine  disorders.6,10   Patients  withchronic TMD frequently report symptoms of depression, poor sleep quality, and low energy.11

As the pain may be aggravated by talking, yawning or chewing it is considered it is considered to have remarkably detrimental effect on ones’ quality of life and is considered to be a pathological clinical symptom representative of  TMD. Further, chronic TMD has been found to interfere with normal social activity and interpersonal relationships and negatively affect the ability to maintain employment.10

Management of TMD often involves a multidisciplinary approach; Dentists, orthodontists, physical therapists, physicians and psychologists work together.12 Conservative treatment is  considered to be the treatment of choice because of the symptomatology of the condition often is improved by use of occlusal splints, physical therapy, medication and orthodontic treatment.13 Current treatment of TMD includes pharmacological intervention, behavior modification, nutritional counseling,occlusal therapy, physical therapy and manual therapy, orthodontics, prosthetics, orthotics and surgery. Considering the complexity of TMD, certain patients  may benefit from more than one treatment modality at any one time.14

 Physical and manual therapy aims to relieve pain, reduce inflammation,  restore normal mandibular function, the proper function of the orofacial musculoskeletal complex and prevent recurrence through a number  of  physical  techniques.12 Numerous physical therapy interventions are potentially effective in managing TMD,including electrophysical modalities, exercise, and manual therapy techniques. Electrophysical modalities include interventions such as ultrasound, microwave, laser, and TENS.12 Oral exercise devices, such as the Therabite Jaw Motion Rehabilitation System are mechanical aids that provide passive stretch to the TMJ to improve mandibular range of motion.12

Physical therapy interventions often include therapeutic exercises for the masticatory or cervical spine muscles to improve strength and mobility in the region.15 Manual therapy techniques are commonly used to reduce pain and restore mobility.12 Physical and manual therapy is used in conjunction with other treatment modalities and for post surgical rehabilitation.16 The fact that physical and manual therapy techniques are non-invasive and does not appear to be fraught with irreversible changes makes it a very applicable modality in the area of clinical TMJ dysfunction management.17 One of the more popular and widely used manual therapy techniques in the management of

musculoskeletal disorders is the Muscle energy technique.

Many reviews of the conservative management of TMD have been published recently, often recommending a multidisciplinary approach, but the research  evidence supporting the approach is not provided. The American academy of Craniomandibular disorders and  the Minnesota Dental Association  have  cited  physical therapy as an

important treatment.18

Manual therapy is one of the most important physical therapy resources for TMD patient’s treatment. Carlsson G et al report that, the most useful techniques for re- education and rehabilitation of the masticatory muscles are manual therapy, musclestretching and muscle strengthening exercise.14  There are a host of manual therapytechniques available in the physical therapist’s arsenal, and now with the development of low intensity passive mobilization techniques of joint and soft tissue structures, they are increasingly used in the various musculoskeletal problems.18  However, fewstudies have verified the effect of these therapeutic interventions.19  Manual therapyhas also been showed to more cost effective and less prone to side effects than dental treatment.18 MET is found to be effective in reducing pain in different parts of the body as shown in longitudinal studies.20,21 But its effect on TMD is controversial.

 Hence this study is undertaken with the intention of determining the effects of MT in reducing pain, maximal mouth opening, reducing tenderness, to improving cervical range of motion, to  improving quality of life for  the management of patient with  Temporomandibular disorder (TMD).

1.2NEED OF 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 and Temporomandibular disorder (TMD)  is an important public health problem in all nations and day by day it is increasing. So need is arise to solve this problem.

1.4 OBJECTIVE OF STUDY

To study the effect of Muscle energy technique in reducing pain and increasing the range of mouth opening (MMO) in patients with TMD

To study the effect of dry needling in reducing pain and increasing the range of mouth opening (MMO) in patients with TMD

To study the effect of MET in combined with  dry needling in reducing pain and increasing the range of mouth opening (MMO) in patients with TMD

2. REVIEW OF LITERATURE

Muscle energy techniques (MET) are used to treat muscles with excessive tension, which limit joint motion and cause pain.²¹ MET can be used to lengthen a shortened, contractured or spastic muscle; to strengthen a physiologically weakened muscle; to reduce localized oedema and to relieve passive congestion.²² Treatment of TMJ using MET has been limited in its documentation, although MET may have beneficial outcome on the pain frequently seen in TMD. MET is useful in reducing tension in

the jaw muscle, improving joint motion and subsequently reducing pain, be it localized or referred to the face and head. MET is of considerable value in the resolution of the musculoskeletal component of TMJ pain and dysfunction.²³ As MET works on both the TMJ and the muscles of mastication (mainly the temporalis and masseter) it is considered to be appropriate for treating both the limitation of mouth opening and the muscular component (strain and/or hypertonicity) of TMD.²¹

The Golgi tendon receptors play an important role in MET. MET  stimulates  the muscle spindles and Golgi tendon organs reducing excessive activity.³ Stretching of the muscle fibers stimulates the Golgi tendon receptors, which  have an inhibitory influence on muscle tension, leading to muscle relaxation.²⁴ The principle is based on the theory that when a muscle is actively contracted, its antagonists are reflexively relaxed. Therefore, opening the mouth against resistance is inclined to  relax contracted elevator muscle and vice versa for opening muscles.²³      

Dijkstra et al (2007) conducted a study to assess the validity and reliability of 4 four different methods of assessing the TMJ mobility. At maximal mouth opening measurement of inter-incisal distance, angular displacement of the mandible relative to the closed mouth position of the mandible and angular displacement of the mandible relative to cranium, and assessment of the condylar position relative to the articular eminence performed on transpharangeal radiographs. The results showed that maximal mouth opening measurement of inter-incisal distance is a reliable and valid TMJ mobility assessment^.25

McNeely et al (2006) conducted a qualitative systemic review to assess the evidence of    effectiveness   of   physical   therapy   interventions    in   the    management    of  temporomandibular disorders. Results revealed that, among the six studies done to evaluate manual and exercise therapy, two studies supported the use of exercises, while only one study supported manual therapy in the management of TMD. They conclude that, since most of the studies were of very poor methodological quality, the findings should be interpreted with caution.¹²

Cleland and Palmer (2004) conducted a single case A1-B-A2 study to determine if manual physical therapy, therapeutic exercise, and patient education would be an effective management strategy for a patient with a disc displacement without reduction. They conclude that manual physical therapy, therapeutic exercise and patient education may be an effective management strategy for a patient with bilateral disc displacement without reduction of the TMJ and that further outcome studies in the form of RCT are needed to determine the clinical utility of this treatment approach in a larger population.²⁶

Nicolakis P et al (2002) conducted a prospective controlled study to evaluate the effectiveness of exercise therapy in 20 patients suffering from Myofacial pain dysfunction (MPD). The treatment consisted of active and passive jaw movement exercises, correction of body posture and relaxation techniques. Patients were evaluated for pain at rest, pain at stress, impairment and mouth opening at baseline, before and after treatment and at 6 month follow-up. Results showed after treatment pain at  stress, impairment and  incisal edge  clearance  improved  significantly. They concluded that exercise therapy seems to be useful in the treatment of MPD syndrome.²⁷

Nicolakis P et al (2001) conducted a prospective controlled study to evaluate the effectiveness of exercise therapy in 20 patients with internal derangement of the TMJ. The treatment consisted of active and passive jaw movement exercises, correction of body posture and relaxation techniques and home program. Results showed that pain, impairment and mouth opening improved significantly as a result of treatment, and four patients had no pain at all and only seven patients revealed an impaired incisal edge  clearance.  They  concluded  that  exercise  therapy  seems  to  be  useful  in  the treatment of anterior disc displacement without reduction.28

Scrimshaw and Maher (2001) conducted a randomized controlled trial to compare the responsiveness of the McGill Pain Questionnaire with the Visual Analogue Scale (VAS). All patients completed both a VAS and McGill pain scale to describe their pain over the last 24 hours and a separate VAS to describe their current pain. Results showed that the VAS was less responsive to clinical change when used to rate current pain in comparison with pain over the last 24 hours. The study found that the VAS was more responsive than the McGill Pain Questionnaire when both instruments were used to rate pain over the last 24 hours. They concluded that the VAS may be a better tool  than  the  McGill  Pain  Questionnaire  for  measuring  pain  in  clinical  trials  and clinical practice.²⁹

Nicolakis P et al (2000) conducted a prospective controlled study to evaluate the effectiveness of exercise therapy in 30 patients with reduced anterior disc displacement. The treatment consisted of active and passive jaw movement exercises, correction of body posture and relaxation techniques and home program. Results showed that pain, impairment and mouth opening improved significantly as a result of treatment. They concluded that exercise therapy seems to be useful in the treatment of anterior disc displacement with reduction.³⁰

Friedman MH et al (1993) in a single case study of TMJ hypomobility caused by capsular restrictions state that TMJ manipulation by condylar distraction during opening, protrusion, and lateral movements, and a simple stretching exercise, and resistive opening and closing exercises at full opening to relax the lateral pterygoid muscles, with each exercise repeated five times for five sessions a day resulted in the successful management in the form reduced pain and increased MMO of a child with presurgically and postsurgically hypomobile right TMJ.³¹

Lewit K and Simons DG (1984) systematically tested the effect of MET (post- isometric relaxation) on 351 tight and tender muscle groups that are commonly associated with musculoskeletal pain  in 244  patients. They report that the method produced immediate pain relief. They conclude that post isometric relaxation technique is useful in addition to, or in place of, local anesthetic injection or dry needling and they confirm other observations that increased tension of the affected muscles and the resulting pain and dysfunction are both relieved by restoring the full length of the muscle.³

3. MATERIALS AND METHODOLOGY        

3.1 Study Design

 The study used experimental design; single blinded, parallel randomized clinical trial which was used to determine the efficacy of MT and dry needling on. It was conducted from August 2017 to completed 2019 at Out Patient Department (OPD), Department of Physiotherapy, Lovely Professional University, Phagwara, India. The study received ethical clearance from the Institutional Human Ethical Committee (ethical clearance number LPU/IEC/01/09) and the study protocol was registered with the clinical trials.gov registry ( 000000). Written informed consent was taken from all participants.

3.2 Study Setting

Data for the study will obtain from Out Patient Department (OPD), Department of Physiotherapy Lovely Professional University campus, Phagwara, Punjab. and different different dental clinic from jalandhar. 

3.3 Population and Sampling

The participants who met the inclusion criteria were included in the study. Total 120 participants were selected from Out Patient Department (OPD), Department of Physiotherapy, Lovely Professional University campus, Phagwara, Punjab and allocated to three groups of 40 each for the study. Study group-A received combinationof dry needlingand manual therapy, study group-B received manual therapy and study group-C received dry needling. All the group were advised to do home exercise. Method of sampling was random sampling throgh lottery method.

3.4 Selection Criteria

3.4.1. Inclusion Criteria

The subjects were included according to the following criteria

1.      Persistent, sudden, disabling, limited MMO of less than 30mm (but not necessarily painful) clearly originating in the TMJ.

2.      Impeded lateral movements towards the unaffected side.

3.      Deviation towards the affected side on opening and protrusive movements

4.      Exacerbated pain or pressure in the affected side of the TMJ.

5.       Patient conditions proved to be refractory to nonsurgical treatment

3.4.1        Exclusion Criteria

The subjects were excluded according to the following criteria.

1.      Degenerative TMJ arthritis.Inflammatory TMJ arthritis

2.      Infective TMJ arthritis.

3.      Malignant tumours of the face and jaw

4.      History of dislocation of TMJ.

5.      History of fracture of jaw

6.      History of previous surgery of jaw or TMJ.

7.      Patients on anti inflammatory and analgesic drugs 

3.5 Group Allocation:

The subjects were randomly assigned into three groups by simple random sampling, such as group A, group B and group C and the treatment plan is allocated as follows:

Group-A dry needling combined with Manual Therapy

Group-B  received Manual Therapy.

Group-C received dry needling

3.7  Procedure

 The subjects who will fulfill the inclusion and exclusion criteria and willing to participate in the study will be randomly assigned one of two groups after obtaining written informed consent. Both groups undergone  treatment for four weeks and both group will be taken spinal and head stabilization exercise

Interventions

Manual Therapy in Combination With Dry Needling

Participants received a maximum of nine treatments over a time frame ranging from 2 to 5 weeks at a frequency of 1–2 sessions per week. Treatment included MWM directed at the TMJ and cervical spine, thoracic spine thrust manipulation, and TrP-DN.

Manual Therapy

The MWM technique followed the principles described by Oliver (2011). The therapist stood behind the seated patient, placing their palms on both sides of the patient’s head, with the thumbs over the zygomatic arches, to stabilize the head. The index fingers were placed parallel and immediately anterior to the posterior border of the mandible, passing over the TMJ. The third and fourth fingers of each hand were positioned behind the posterior border of the ramus of the mandible, just above the mandibular angle. This hand placement allowed the therapist to apply transverse force across the mandible as necessary, while at the same time allowing an anterior–inferior gliding force to the mandible on the side of restriction, while also controlling the unrestricted side, inhibiting any excessive mandibular forward gliding with the other hand.

The combination of these manual forces allowed the mandible to maintain a midline position during mouth opening, enabling a larger range of jaw motion. The therapist could select one or several different glide directions, depending on the patient’s clinical presentation and response to the application of the technique. Pain and movement were always the guide for technique modification. If increased pain-free movement was achieved, then three sets of 10 repetitions were performed at each subsequent session. Once full-range, pain-free movement was achieved, the patient applied overpressure into depression with his/her fingers on the chin, sustaining this force for three seconds. The cervical flexion-rotation test (FRT) was used to identify impairment of motion of the C1/2 motion segment and consequently an indicator to apply a C1/2 MWM technique (Hall, Briffa, and Hopper, 2008). For the FRT, the patients were positioned in supine lying and the therapist passively flexed the cervical spine to end-range. The therapist then rotated the head to the left and then to the right. A positive test was indicated by a limitation of rotation (Ogince, Hall, Robinson, and Blackmore, 2007). Range of rotation is usually 40–44° to each side (Hall and Robinson, 2004; Ogince, Hall, Robinson, and Blackmore, 2007) in asymptomatic subjects, while a range limited to 33° or less indicates a positive result (Hall, Briffa, Hopper, and Robinson, 2010). Previous reports indicate high intra-rater reliability for ROM measured by trained examiners using the FRT (ICC: 0.95, 95% CI: 0.90–0.98) (Hall, Briffa, Hopper, and Robinson, 2010). Furthermore, ROM recorded during the test and examiner interpretation of the test has been shown to be consistent over time with a κ of 0.92 and a minimal detectable change of at most 7° (Hall, Briffa, Hopper, and Robinson, 2010). When a positive test was identified, a C1/2 SNAG was applied according to the guidelines suggested by Mulligan (2010). A horizontal, anteriorly directed force was applied with the distal phalanx of the thumbs over the C1 transverse process on the contralateral side of the limited rotation. While sustaining this glide, the patient actively rotated the head in the direction of the limitation, based on the FRT as seen in Figure 2. This procedure was repeated on subsequent visits, ceasing when full range was achieved on the FRT. We will use the nomenclature suggested by Mintken, DeRosa, Little, and Smith (2008) in the description of the thoracic spine thrust manipulation used in this case series. At each session all patients received a high-velocity, end-range, anterior–posterior force applied through the elbows to the upper thoracic spine on the mid-thoracic spine in cervicothoracic flexion with the patient in supine as seen in Figure 3. The therapist used the manipulative hand to stabilize the inferior vertebra bone of the motion segment targeted and used the upper trunk to apply a force through the patient’s arms and performed a high-velocity, low-amplitude thrust. Patients received two manipulative interventions, each session targeting thoracic segments T1–T4

Dry Neeedling

During all treatment sessions, the patient received the TrP-DN technique directed at the temporalis and masseter muscles active TrPs. The TrP-DN procedure used was similar to the TrP injection described by Hong (1994). The TrP was compressed by the index finger or middle finger of the non-dominant hand of the therapist to direct the placement of the needle tip while inserting the needle. An acupuncture needle, 0.2 in. in length, was held by the therapist’s dominant hand. The needle was inserted into the skin at a point above the taut band over the TrP as seen in Figure 4. After penetration of the needle into the skin tissue, it was directed to the muscle TrP until a first local twitch response was provoked. Then, the needle was inserted and withdrawn from the TrP rapidly. With rapid movement of needle, a local twitch response can be elicited if the needle tip encounters a sensitive locus. The needle insertions were repeated to elicit as many local twitch responses as possible. On each session, 2–3 min was approximately required for the procedure.

EXERCISE:

Therapeutic Jaw Exercise

3.9. Outcome Measures Monitoring

Numeric Pain Rating Scale

The numeric pain rating scale (NPRS) was a self-stated pain measurement scale which needs the patients to verbally rate their pain on a 0-10 scale where “0 being no pain and 10 being worst pain imaginable” (Katz J and Melzack R, 2009). This scale is the most commonly used scale in medical profession (Jamison RN, 1996). The test-retest validity and reliability had been observed to be enough to utilize in patients among chronic low back ache (Jensen et al., 1999). The NPRS score might be evaluated among the VAS and should outcome in a like score as the VAS transformed from millimeters to centimeters. Ohnhaus and Adler observed when the NPRS and VAS were applied in tandem, the scores might be arithmetically controlled and the numeric values compare fit for pain rating (r = 0.85, p-value less than 0.01) and for pain relief (r = 0.83, p-value less than 0.01) (Ohnhaus EE and Adler R., 1965) .

 Maximal Mouth Opening

The secondary outcome included maximal painfree mouth opening (MMO). MMO was measured with patients in the seated position utilizing a 10-cm plastic ruler marked in millimeters. Patients were instructed to “open their mouth as wide as possible without causing an increase in their pain or discomfort” (Walker, Bohannon, and Cameron, 2000). At the end position of MMO, the distance between the upper and lower central incisors was assessed in millimeters. Intra-rater reliability has shown to be acceptable when measuring mandibular opening in millimeters (ICC: 0.90–0.98) (Dworkin, LeResche, DeRouen, and Von Korff, 1990). We assessed mouth opening since this is one of the most common limitations in this patient population. 

Quality of life

SF-36 (The MOS 36-item short form health survey) form is used as a general quality of life scale. This form was developed by Ware and his co-workers and its Turkish validity and reliability adaptation was made by Kocyigit and his co-workers(KocyiÄŸit et al., 1999). The form is composed of a total of 36 items that can be filled by the patient. These items include 8 different dimensions concerning health. Physical function (10 items), social function (2 items), physical problems-related role constraints (3 items), emotional problems-related role constraints (3 items), mental health (5 items), liveliness (4 items), pain (2 items) general health [general perspective (5 items) and alteration in health (1 item)]. Items are scored (0 = poorest health state, 100 = best health state) and are evaluated one by one. By subscales, it evaluates the health between 0-100; and 0 indicates poor health state, 100 indicates good health state.

Algometer Method:

The wagner FDX-25 Algometer was used to measure pressure pain threshold  i.e. to detect minimal pressure that induced pain. The patient was in sitting position. Firstly trigger points were identified in the occipital area. Minimal three trigger points were considered then algometer was placed on the identified trigger point at 90°. Apply the pressure in Kgf and asked the patient, "Let me know when your pain will convert from comfort to discomfort sensation or Let me know when your pain will not be tolerable by you or see the apprehension sign on the face of the patient."  Then the Therapist note the pressure in Kgf when patient says its intolerable. After the treatment protocol of 4 weeks again the algometer pressure reading were noted on the same trigger points and check the differences.

 Statistical tools used:

The statistical analysis is deliberated to be the essential part of any quantitative research. This type of analysis ensures the researcher in testing the hypothesis formulated in supporting the research objectives and generation of results subsequently in supporting the deductive approach endorsed in this study.  The following are the statistical tools that are majorly used for the quantitative analysis of gathered data:

Paired t-test

ANNOVA

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