Clinical trial NCT04477122: Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome.
Official title: Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Keywords: temporomandibular joint
temporomandibular joint syndrome
temporomandibular joint dysfunction
extracorporeal shock waves
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: experimental one and placebo group, receiving the intervention at the same time
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Temporomandibular joint pain
timeFrame: Baseline
measure: Temporomandibular joint pain
timeFrame: At one month
measure: Temporomandibular joint pain Temporomandibular joint pain
timeFrame: At two months
measure: Neck function
timeFrame: Baseline
measure: Neck function
timeFrame: At one month
measure: Neck function
timeFrame: At two months
Secondary outcomes:
measure: Pain threshold
timeFrame: Baseline
measure: Pain threshold
timeFrame: At one month
measure: Pain threshold
timeFrame: At two months
measure: Headache impact in quality of life
timeFrame: Baseline
measure: Headache impact in quality of life
timeFrame: At one month
measure: Headache impact in quality of life
timeFrame: At two months
measure: Dizziness
timeFrame: Baseline
measure: Dizziness
timeFrame: At one month
measure: Dizziness
timeFrame: At two months
measure: Quality of life Measured with SF-12
timeFrame: Baseline
measure: Quality of life Measured with SF-12
timeFrame: At one month
measure: Quality of life Measured with SF-12
timeFrame: At two months
measure: Temporomandibular joint function
timeFrame: Baseline
measure: Temporomandibular joint function
timeFrame: At one month
measure: Temporomandibular joint function
timeFrame: At two months
measure: Temporomandibular joint function
timeFrame: Baseline
measure: Temporomandibular joint function
timeFrame: At one month
measure: Temporomandibular joint function
timeFrame: At two months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Clinica Fisiomedic
Study officials:
References: