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

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477122
• Other study ID #: UJaen Posture
• Status: Completed
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: January 2021
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 25, 2021
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Syndrome
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Manual therapy and extracorporeal radial shock waves therapy
25 minutes of manual therapy, 5 minutes of temporomandibular joint mobilization and 3 minutes of extracorporeal radial shock waves therapy (real or placebo)

Locations

Country	Name	City	State
Spain	Clinica Fisiomedic	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temporomandibular joint pain	Actual local pain at temporomandibular joint measured with Numerical pain rating scale	Baseline
Primary	Temporomandibular joint pain	Actual local pain at temporomandibular joint measured with Numerical pain rating scale	At one month
Primary	Temporomandibular joint pain Temporomandibular joint pain	Actual local pain at temporomandibular joint measured with Numerical pain rating scale	At two months
Primary	Neck function	Neck Disability Index, a 10 questions scale about neck function	Baseline
Primary	Neck function	Neck Disability Index, a 10 questions scale about neck function	At one month
Primary	Neck function	Neck Disability Index, a 10 questions scale about neck function	At two months
Secondary	Pain threshold	Beginning of pain feeling referred at pressure with algometer at temporomandibular joint	Baseline
Secondary	Pain threshold	Beginning of pain feeling referred at pressure with algometer at temporomandibular joint	At one month
Secondary	Pain threshold	Beginning of pain feeling referred at pressure with algometer at temporomandibular joint	At two months
Secondary	Headache impact in quality of life	Headache Impact Test (HIT-6) consisting on six questions	Baseline
Secondary	Headache impact in quality of life	Headache Impact Test (HIT-6) consisting on six questions	At one month
Secondary	Headache impact in quality of life	Headache Impact Test (HIT-6) consisting on six questions	At two months
Secondary	Dizziness	Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life	Baseline
Secondary	Dizziness	Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life	At one month
Secondary	Dizziness	Dizziness measured with Dizziness Handicap Inventory, 25 questions about the impact of dizziness in patient's life	At two months
Secondary	Quality of life Measured with SF-12	12 questions about quality of life perceived	Baseline
Secondary	Quality of life Measured with SF-12	12 questions about quality of life perceived	At one month
Secondary	Quality of life Measured with SF-12	12 questions about quality of life perceived	At two months
Secondary	Temporomandibular joint function	Fonseca Anamnesis Index, 10 questions about temporomandibular joint function	Baseline
Secondary	Temporomandibular joint function	Fonseca Anamnesis Index, 10 questions about temporomandibular joint function	At one month
Secondary	Temporomandibular joint function	Fonseca Anamnesis Index, 10 questions about temporomandibular joint function	At two months
Secondary	Temporomandibular joint function	Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function	Baseline
Secondary	Temporomandibular joint function	Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function	At one month
Secondary	Temporomandibular joint function	Short form of Fonseca Anamnesis Index, 5 questions about temporomandibular joint function	At two months