Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome.
Condition: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to assess the effects of radial shock wave therapy in the treatment
      of temporomandibular joint syndrome. For this objective, subjects recruited will be allocated
      in an experimental group or a placebo group. Both groups will receive one manual therapy and
      radial shock waves therapy (real for experimental group, a sham device for placebo group)
      session per week along one month. Pain, neck function and quality of life measured will be
      performed before the intervention, after the last treatment and at one month follow-up.
    

Detailed description: 
      Temporomandibular Disorders (TMDs) are a subgroup of painful orofacial disorders of the
      stomatognathic system, characterized by TemporoMandibular Joint (TMJ) pain, fatigue of the
      cranio-cervico-facial muscles (especially the masticatory muscles), limitation of mandibular
      movement and the presence of a click or crackling sound in the ATM.

      The main signs and symptoms associated with TMDs are bruxism (33%), myofascial pain (14%),
      headache (96%) and functional limitation (93%), the latter being related to posture.

      The quality of life of patients with TMD involvement is diminished in various facets of their
      lives, leading to a private expense for the patient as well as a public expense resulting
      from a poor referral due to the lack of adequate treatment for TMDs. This expense ranges in
      Spanish public hospitals at € 146.9 with a minimum of € 52 and a maximum of € 425.

      From this study, we are going to carry out a non-invasive, analgesic, anti-inflammatory
      treatment and without negative side effects for the patient through radial extracorporeal
      shock waves (rESWT), and manual therapy (TM).

      Among the effects produced by shock waves we find that they improve circulation due to
      increased blood flow and oxygenation, at tissue level the permeability of the membrane
      increases and its metabolic process, therefore facilitating the activation of tissue
      regeneration processes experiencing dystrophic changes. Furthermore, shock waves cause
      anti-inflammatory effects and muscle relaxation.

      The main objective of the study is to evaluate the capacity of the shock waves to improve the
      alterations due to temporomandibular disorders. To meet the above objective, a single-blind
      randomized clinical trial study has been designed. The selected subjects will be of legal age
      diagnosed with temporomandibular disorder and those subjects that due to their own
      characteristics are not able to carry out the study will be excluded. Subjects will receive a
      weekly physical therapy session for four weeks. Subjects will be randomly assigned to two
      groups: T1 intervention group consisting of subjects who will receive manual therapy
      treatment and shock waves and T2 placebo group in which the subjects will receive manual
      therapy and placebo shock waves.

      Subjects will be evaluated using sociodemographic variables such as age, sex, weight, height,
      Body Mass Index, educational level, work, smoking, alcohol and physical activity and function
      tests and quality of life questionnaires will be used. Measurements will be made pre and
      post-treatment, one month after the last evaluation, the measurements will be made again for
      follow-up. The intervention will be one day a week for four consecutive weeks.

      The data will be collected using a self-implementing questionnaire, these data will be
      transferred to an excel table and then transferred to SPSS 19.0 (SPSS Inc., Chicago, IL) and
      MedCalc 19.1 (MedCalc Software Bv, Ostend, Belgium, http: // wwww .medcalc.org; 2019) for the
      subsequent statistical analysis, the data being stripped of any direct reference to the
      subject to preserve confidentiality.

      The descriptive analysis will be carried out with means and standard deviations for
      continuous variables, frequencies and percentages for categorical variables. The normality of
      the continuous variables will be calculated with the Kolmogorov-Smirnov test and the
      homocedasticity of the sample with the Levene test.

      All the statistical analysis will be carried out with a confidence level of 95% (p <0.05),
      for the comparison of the two groups we will use the Student's t-test and the Chi-square
      test. Comparisons between treatment group and placebo group will be made using repeated
      measures analysis of variance and ANOVA, followed by Bonferroni to compare measures
      replicated over time.
    

Intervention name(s): Manual therapy and extracorporeal radial shock waves therapy
Intervention type(s): Other
Intervention description(s): 25 minutes of manual therapy, 5 minutes of temporomandibular joint mobilization and 3 minutes of extracorporeal radial shock waves therapy (real or placebo)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups: experimental one and placebo group, receiving the intervention at the same time
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: temporomandibular joint; temporomandibular joint syndrome; temporomandibular joint dysfunction; extracorporeal shock waves