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

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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Intervention / Treatment: Other: Manual therapy and extracorporeal radial shock waves therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41000
    • Clinica Fisiomedic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Blue; 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; 25 minutes of manual therapy, 5 minutes of temporomandibular joint mobilization and 3 minutes of extracorporeal radial shock waves therapy (real or placebo)
PLACEBO_COMPARATOR: Red; 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; 25 minutes of manual therapy, 5 minutes of temporomandibular joint mobilization and 3 minutes of extracorporeal radial shock waves therapy (real or placebo)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Jaen

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2020
• Primary Completion (ACTUAL): December 29, 2020
• Study Completion (ACTUAL): January 25, 2021

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (ACTUAL): July 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: temporomandibular joint dysfunction; temporomandibular joint; temporomandibular joint syndrome; extracorporeal shock waves
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Syndrome; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: UJaen Posture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available under request to the authors/promotor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No