Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome. A Randomized Clinical Trial

Conditions
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Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome

Intervention / Treatment
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* Other: Manual therapy and extracorporeal radial shock waves therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed of temporomandibular disorder by medical doctor. Exclusion Criteria: Subjects who due to their own characteristics are not able to carry out the study tests

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups: experimental one and placebo group, receiving the intervention at the same time
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blue<br>Four sessions (one per week along one month) of manual therapy (25 minutes of massage on temporal, masseter and pterygoid muscles and 5 minutes of joint passive mobilization) and 3 minutes (2000 shots approximately) of extracorporeal radial shock waves therapy on painful points of masseter and temporal muscles at 2 bars and 10 Hertzs. Participants will wear splint 23 hours/day | Other: Manual therapy and extracorporeal radial shock waves therapy<br>* 25 minutes of manual therapy, 5 minutes of temporomandibular joint mobilization and 3 minutes of extracorporeal radial shock waves therapy (real or placebo)<br>|
| Placebo Comparator: Red<br>Four sessions (one per week along one month) of manual therapy (25 minutes of massage on temporal, masseter and pterygoid muscles and 5 minutes of joint passive mobilization) and 3 minutes of placebo extracorporeal radial shock waves therapy on painful points of masseter and temporal muscles. Participants will wear splint 23 hours/day | Other: Manual therapy and extracorporeal radial shock waves therapy<br>* 25 minutes of manual therapy, 5 minutes of temporomandibular joint mobilization and 3 minutes of extracorporeal radial shock waves therapy (real or placebo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporomandibular joint pain | Actual local pain at temporomandibular joint measured with Numerical pain rating scale | Baseline | 
| Temporomandibular joint pain | Actual local pain at temporomandibular joint measured with Numerical pain rating scale | At one month | 
| Temporomandibular joint pain Temporomandibular joint pain | Actual local pain at temporomandibular joint measured with Numerical pain rating scale | At two months | 
| Neck function | Neck Disability Index, a 10 questions scale about neck function | Baseline | 
| Neck function | Neck Disability Index, a 10 questions scale about neck function | At one month | 
| Neck function | Neck Disability Index, a 10 questions scale about neck function | At two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain threshold | Beginning of pain feeling referred at pressure with algometer at temporomandibular joint | Baseline | 
| Pain threshold | Beginning of pain feeling referred at pressure with algometer at temporomandibular joint | At one month | 
| Pain threshold | Beginning of pain feeling referred at pressure with algometer at temporomandibular joint | At two months | 
| Headache impact in quality of life | Headache Impact Test (HIT-6) consisting on six questions | Baseline | 
| Headache impact in quality of life | Headache Impact Test (HIT-6) consisting on six questions | At one month | 
| Headache impact in quality of life | Headache Impact Test (HIT-6) consisting on six questions | At two months | 
| Dizziness | Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life | Baseline | 
| Dizziness | Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life | At one month | 
| Dizziness | Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life | At two months | 
| Quality of life Measured with SF-12 | 12 questions about quality of life perceived | Baseline | 
| Quality of life Measured with SF-12 | 12 questions about quality of life perceived | At one month | 
| Quality of life Measured with SF-12 | 12 questions about quality of life perceived | At two months | 
| Temporomandibular joint function | Fonseca Anamnesis Index, 10 questions about temporomandibular joint function | Baseline | 
| Temporomandibular joint function | Fonseca Anamnesis Index, 10 questions about temporomandibular joint function | At one month | 
| Temporomandibular joint function | Fonseca Anamnesis Index, 10 questions about temporomandibular joint function | At two months | 
| Temporomandibular joint function | Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function | Baseline | 
| Temporomandibular joint function | Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function | At one month | 
| Temporomandibular joint function | Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function | At two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular joint, temporomandibular joint syndrome, temporomandibular joint dysfunction, extracorporeal shock waves