Effectiveness of Manual Therapy in Patients With Tinnitus and Temporomandibular Joint Disorder.
Condition: Tinnitus
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Tinnitus
Study type: Interventional

Summary: 
      Tinnitus is one of the most prevalent symptoms that causes more disability in patients with
      temporomandibular disorder (TMD). The present study postulates a possible link between
      temporomandibular joint (TMJ) and inner ear based on their anatomical, biomechanical and
      physiological relationship, proposing a physiotherapy treatment for the temporomandibular
      joint to improve tinnitus. The aim of the study is to evaluate the effectiveness of adding
      specific manual therapy to a multimodal physiotherapy treatment in patients with tinnitus and
      temporomandibular disorder.
    

Detailed description: 
      1. - INTRODUCTION

           Tinnitus is one of the most prevalent symptoms that causes more disability in patients
           with temporomandibular disorder (TMD).

           According to various studies, the incidence varies between 19-69%, with a 2:1 ratio
           between women and men, being higher in Western industrialized countries. Frequent
           conjunction between TMJ problems and tinnitus has led to propose the existence of a link
           between these two clinical entities. However, the mechanism linking TMD and this
           otologic symptom is unknown.

           The present study postulates an association based on the anatomical relationship between
           the TMJ and the inner ear. The ligaments of the inner ear bones are close to TMJ
           ligaments so the movements of the mandibular condyle may influence on them. The
           discomallear ligaments (DML) and the anterior mallear ligament (AML) can be considered
           as intrinsic ligaments of the TMJ.

           TMJ blood supply depends on the tympanic and auricular arteries, and in its innervations
           are involved nerve branches of the masseter, lateral and temporal/ internal pterygoid,
           key muscles for the condylar movements (open and close the mouth and lateral movements).

           The hypothesis supporting the link between the TMJ and the tinnitus is that the forced
           movements of the mandibular condyle produce a ligaments stretching and muscles tension,
           being the cause of otologic problems such as tinnitus.

           Tinnitus is defined as the perception of a sound that does not exist in the environment.
           It is often described as "a buzz, a beep, a noise". Most conservative treatments for
           tinnitus have focused on pharmacological treatments (particularly antidepressants),
           cognitive-behavioral treatments, medical low strength laser therapies, acupuncture,
           cranial magnetic stimulation, music therapy and environmental sounds reduction
           technologies. However, there is controversial evidence on the effectiveness of these
           techniques given the heterogeneity of protocols and of the response variables.

           Is understood as TMJ pathology, those organic or functional nosological entities
           affecting the craneomandibular system relationship. They encompass a large number of
           disorders, not only traumatic, neoplastic, autoimmune or infectious, but also those
           deriving from dysfunctional alteration of its internal structure, both muscle and
           joints.

           TMJ disorders with a myofascial or joint dysfunction origin are those whose origin is in
           myofascial muscle disorders or in joint by mechanical causes. Myofascial trigger points
           pain, described by Travell and Simons, corresponds to a noninflammatory regional muscle
           pathology that can occur in any striated muscle of the body. Its main feature is the
           presence of a hypersensitive area called trigger point, which is present in a palpable
           taut band of muscle tissue and has the ability to refer pain to distant areas. Joint
           dysfunction is defined as one in which occurs an abnormal relationship between the joint
           disk and the condyle, the fossa and the TMJ eminence.

           Many treatments have been applied to the TMJ with varying degrees of evidence: the
           prevention of bad habits and parafunctions; contract/relax muscles and mental exercises;
           heat / cold in pain or contracture areas; physiotherapy; psychotherapy; biofeedback
           techniques with self-relaxation procedures; resting splints, muscle discharge or
           recapture; transcutaneous electrical nerve stimulation and ultrasound and drug
           treatment: NSAIDs, analgesics, anxiolytics, hypnotics, muscle relaxants and
           antidepressants.

           In most cases, the physiotherapy in patients with TMD is focused on myofascial treatment
           and massage and, at present, in manual therapy (for pain control and improving joint
           movement). All of this, usually combined with splints or bite plates (for pain control,
           bruxism and improving occlusion), although there is little evidence supporting their
           use.

           In relation to myofascial therapy, massage applied on the masticatory muscles, protocols
           of manual therapy on TMJ, as well as mobilization and manipulation techniques of the
           upper cervical spine, there is a wide and proven evidence of the improvement occurring
           in pain, mouth maximum mouth opening and in pressure pain threshold in patients with
           TMD; although systematic reviews on all manual therapy techniques present a
           controversial evidence, given the heterogeneity of the studies.

           In the literature review made, it has not been found any paper issuing a proposal or
           treatment protocol of the TMJ presenting among its main objectives the control of the
           intensity of TMJ pain and the decrease of disability that tinnitus produces.

           Only one found study proposes a treatment to reduce the intensity of TMJ pain and to
           improve the disability that tinnitus produces by using a bite splint, without performing
           a manual intervention therapy and exercises.

           The purpose of the present study is to raise a proposal of treatment with manual therapy
           and exercise aiming to reduce the disability caused by tinnitus and the intensity of
           pain and disability caused by the TMD.

        2. - JUSTIFICATION

           Tinnitus is one of the most prevalent symptoms that causes more disability in patients
           with temporomandibular dysfunction (TMD).

           The frequency with which concur the problems of the temporomandibular joint (TMJ) and
           tinnitus, has led to propose the existence of an association between these two clinical
           entities.

           The present study postulates the possible link developing an
           anatomical-pathophysiological hypothesis based on the relationship between TMJ and inner
           ear, proposing a treatment applied to temporomandibular joint for improving TMJ pain and
           tinnitus.

        3. - HYPOTHESIS AND OBJECTIVES

      Hypothesis:

      The addition of specific manual therapy techniques (TM) within a multimodal physiotherapy
      treatment is more effective in improving TMJ pain and disability that causes tinnitus that
      the isolated application of multimodal treatment.

      Objectives:

      General:

      Evaluate the effectiveness of adding specific manual therapy to a multimodal physical therapy
      in patients with tinnitus and TMD with a myofascial origin or joint dysfunction.

      Specific:

        1. Evaluate the effectiveness of adding specific manual therapy to a multimodal physical
           therapy in patients with tinnitus and TMD in reducing pain intensity and disability
           caused by TMD.

        2. Evaluate the effectiveness of adding specific manual therapy to a multimodal physical
           therapy in patients with tinnitus and TMD in reducing the intensity of tinnitus and
           disability caused by tinnitus.

        3. Evaluate the effectiveness of adding specific manual therapy to a multimodal physical
           therapy in patients with tinnitus and TMD in increasing the range of motion of the TMJ.

        4. Evaluate the effectiveness of adding specific manual therapy to a multimodal physical
           therapy in patients with tinnitus and TMD in the painful rise by pressuring the
           masseter, temporal and lateral pterygoid muscles.

        5. Evaluate the effectiveness of adding specific manual therapy to a multimodal physical
           therapy in patients with tinnitus and TMD in the quality of life, level of anxiety /
           depression and health.

      4. METHODOLOGY

      Type of study: randomized and controlled pilot study, multicenter, blinded randomization,
      patient assessment and data analysis. Treatment characteristics themselves prevent their
      blinded application.

      Location: 3 private consultation rooms of specialized physiotherapy in TMD. Study subjects:
      56 patients with temporomandibular dysfunction and tinnitus.

      The patient will receive six treatment sessions, two sessions in the first week and a weekly
      session to complete the intervention. The total duration of the intervention shall be one
      month. Before starting the study, all patients will be asked to sign an informed consent.

      The statistical analysis will be performed using SPSS 22.0 program (IBM statistical
      software). The average and the standard deviation of quantitative variables will be
      calculated for the descriptive analysis of the sample if normally distributed.

      For the comparative analysis, developed according to the intention to treat:

        1. An ANOVA for repeated measure test should be carry out to evaluate the interaction
           between levels of inter - subject factor (treatment) and the intra- subject (main
           variables response in time) to be interpreted in case it is significant.

        2. To confirm whether this interaction effect is significant, pairwise comparisons will be
           made of the inter-subjects factor levels (treatment) for each level of main response
           variables over time using the Bonferroni method.

      Limitations of the study - Masking: The nature of the applied treatments prevents masking
      therapists and patients. This limitation is inherent to the type of treatment evaluated and
      common with other forms of treatment with similar characteristics, in which therapist should
      inevitably know the type of treatment that is applied. However, this limitation does not
      prevent the controlled clinical trials carried out on these technologies from being of higher
      methodological quality. Thus, in this study, randomization of patients will be blinded,
      allocation of the random sequence, the assessment of patient evolution and analysis of
      results.
    

Intervention name(s): Conventional Physiotherapy; Specific Manual Therapy
Intervention type(s): Other; Other
Intervention description(s): Leaflet care and health habits of the temporomandibular joint.
Program of cranio-cervical and temporomandibular exercises.
Massage of the cervical muscles and self care document for home.; Leaflet care and health habits of the temporomandibular joint.
Program of cranio-cervical and temporomandibular exercises.
Massage of the cervical muscles and self care document for home.
Specific manual therapy techniques focusing on the temporomandibular joint and temporomandibular muscles.
Other intervention name(s): Multimodal Group; Manual Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: physiotherapy, Temporomandibular Joint Disorder, tinnitus.